Clinical Trial Results:
Randomised Phase II Study comparing, as first-line chemotherapy, single-agent Oral Vinorelbine administered with two different schedules (metronomic and weekly schedules) in patients with Advanced Breast Cancer.
Summary
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EudraCT number |
2014-003860-19 |
Trial protocol |
PT ES AT HU RO CZ DE |
Global end of trial date |
28 Sep 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
03 Oct 2021
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First version publication date |
03 Oct 2021
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
PM0259CA233B0
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
Pierre Fabre Médicament
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Sponsor organisation address |
45 place Abel Gance, Boulogne , France, 92100
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Public contact |
Christine TA THANH MINH, PIERRE FABRE MEDICAMENT, +33 (0)149108121, christine.ta.thanh.minh@pierre-fabre.com
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Scientific contact |
Christine TA THANH MINH, PIERRE FABRE MEDICAMENT, +33 (0)149108121, christine.ta.thanh.minh@pierre-fabre.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
07 Nov 2019
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
28 Sep 2020
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To evaluate the Disease Control Rate (CR + PR + SD) in both arms (metronomic and weekly schedules) assessed during study treatments.
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Protection of trial subjects |
This study was conducted in accordance with the ethical principles that have their origin in the current Declaration of Helsinki and was consistent with International Conference on Harmonisation Good Clinical practice (ICH GCP) and applicable regulatory requirements. The study was conducted in compliance with the protocol. The protocol, amendments, the subject information leaflet and the subject informed consent were approved by the appropriate independent Ethics Committee(s) in the involved countries prior to implementation.
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Background therapy |
Preventive medication with an oral 5-HT3 antagonist was recommended before each oral vinorelbine administration. The primary prophylactic use of Colony Stimulating Factor (CSF) was allowed during the treatment period. Granulocyte stimulating growth factors were permitted for patients experiencing febrile neutropenia, Grade 4 asymptomatic neutropenia or neutropenic infection, according to institutional rules. Pre-menopausal patients were allowed to receive LHRH analogues in order to block ovarian functions. Patients received full supportive care throughout the study, including treatment when required with antibiotics, anti-diarrhoeals, analgesics, antiemetics, and transfusion of blood products, according to local guidelines and the investigator’s opinion. Treatment with a bisphosphonate was allowed during the study period. | ||
Evidence for comparator |
This study evaluated two schedules of administration of oral vinorelbine: the metronomic and the weekly schedules.The currently registered and approved regimen of Oral Vinorelbine delivered in a weekly schedule was used as reference arm. | ||
Actual start date of recruitment |
03 Aug 2015
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Italy: 21
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Country: Number of subjects enrolled |
Poland: 29
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Country: Number of subjects enrolled |
Portugal: 16
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Country: Number of subjects enrolled |
Romania: 4
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Country: Number of subjects enrolled |
Spain: 49
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Country: Number of subjects enrolled |
Austria: 5
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Country: Number of subjects enrolled |
Czechia: 5
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Country: Number of subjects enrolled |
France: 22
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Country: Number of subjects enrolled |
Germany: 3
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Country: Number of subjects enrolled |
Hungary: 9
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Worldwide total number of subjects |
163
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EEA total number of subjects |
163
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
76
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From 65 to 84 years |
83
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85 years and over |
4
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Recruitment
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Recruitment details |
A total of 43 centres in 10 countries screened 218 hormone-receptor-positive (HRc) and HER2 negative patients with advanced breast cancer between the 22 of December 2015 and the 13 of December 2017. Of these 218 patients, 164 patients were randomised and 163 patients received at least one dose of study drug. | |||||||||||||||||||||||||||
Pre-assignment
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Screening details |
A 28-day screening period was planned before randomisation and screened HRc-positive and HER2 negative patients with advanced breast cancer. Once the screening period was successfully completed, patients who fulfilled the eligibility criteria were randomised in a 1:1 ratio in the 2 arms. | |||||||||||||||||||||||||||
Period 1
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Period 1 title |
Treatment period (overall trial) (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Arm A: metronomic schedule | |||||||||||||||||||||||||||
Arm description |
Patients received Oral Vinorelbine at metronomic schedules, i.e. three times weekly. | |||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||
Investigational medicinal product name |
Oral vinorelbine
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Investigational medicinal product code |
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Other name |
Navelbine
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Patients received a fixed dose of 50 mg of Oral Vinorelbine (one capsule of 20mg plus one of 30mg) three times weekly (on Mondays, Wednesdays and Fridays or Tuesdays, Thursdays and Saturdays) continuously until disease progression, unacceptable toxicity, patient’s refusal or investigator’s decision. Each 3 weeks of treatment was considered as a separate cycle, therefore in Treatment Arm A, a cycle consisted of 9 fixed doses of 50 mg at days 1, 3, 5, 8, 10, 12, 15, 17 and 19.
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Arm title
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Arm B: weekly schedule | |||||||||||||||||||||||||||
Arm description |
Patients received Oral Vinorelbine at weekly schedules, i.e. once a week. | |||||||||||||||||||||||||||
Arm type |
Active comparator | |||||||||||||||||||||||||||
Investigational medicinal product name |
Oral vinorelbine
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Investigational medicinal product code |
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Other name |
Navelbine
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Patients received Oral Vinorelbine at the dose of 60 mg/m² on day 1, day 8 and day 15 of the first cycle. At the second and following cycles, the day 1, day 8 and day 15 were increased to 80 mg/m², according to haematological tolerance. The dosage was calculated according to BSA, using the Dubois and Dubois formula. Treatment was administered until disease progression, unacceptable toxicity, patient’s refusal or investigator’s decision. Each 3 weeks of treatment was considered a cycle, therefore in Treatment Arm B a cycle consisted of 3 doses at days 1, 8 and 15.
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Baseline characteristics reporting groups
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Reporting group title |
Arm A: metronomic schedule
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Reporting group description |
Patients received Oral Vinorelbine at metronomic schedules, i.e. three times weekly. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Arm B: weekly schedule
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Reporting group description |
Patients received Oral Vinorelbine at weekly schedules, i.e. once a week. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Arm A: metronomic schedule
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Reporting group description |
Patients received Oral Vinorelbine at metronomic schedules, i.e. three times weekly. | ||
Reporting group title |
Arm B: weekly schedule
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Reporting group description |
Patients received Oral Vinorelbine at weekly schedules, i.e. once a week. |
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End point title |
Disease control rate (DCR) [1] | ||||||||||||
End point description |
DCR, defined as the sum of CR, PR and SD rates was observed in 52/82 patients (63.4% [95% CI: 52.0, 73.8]) in Arm A and 59/81 patients (72.8% [95% CI: 61.8, 82.1]) in Arm B.
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End point type |
Primary
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End point timeframe |
DCR according to investigator was calculated among the BOCR responders in the ITT analysis set on the treatment period (from the date of randomisation until the documentation of progression or death due to any cause.
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The study was designed to evaluate the disease control rate in each arm of oral vinorelbine but not to compare the two schedules (metronomic / weekly). No statistical analysis was performed on the primary efficacy endpoint |
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No statistical analyses for this end point |
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End point title |
Duration of disease control | ||||||||||||
End point description |
Overall, for patients who achieved PR or SD (no CR was observed in any arm), 43 (82.7%) patients in Arm A and 44 (74.6%) patients in Arm B experienced disease progression or death. The median time to disease progression or death was 6.9 months (95% CI: 4.2, 8.6) in Arm A and 7.9 months (95% CI: 5.7, 10.0) in Arm B. The distribution of DCR was described by treatment arm using Kaplan-Meier methods, reporting estimated median (in months) with 95% CI, 25th and 75th percentiles and Kaplan-Meier estimated probabilities with corresponding 95% CIs at several time points.
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End point type |
Secondary
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End point timeframe |
Duration of disease control was defined as the period from the date of randomisation until date of PD or death from any cause, whichever occurred first. Only responders (patients with BOCR of CR or PR) and stable patients were included in the analysis.
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Attachments |
Duration of disease control (months) |
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No statistical analyses for this end point |
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End point title |
DCR without grade 3-4 toxicity | ||||||||||||
End point description |
DCR without grade 3-4 toxicity, defined as the sum of CR, PR and SD without grade 3-4 toxicity rates, was observed in 24/82 patients (29.3% [95% CI: 19.7, 40.4]) in Arm A and 18/81 patients (22.2% [95% CI: 13.7, 32.8]) in Arm B.
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End point type |
Secondary
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End point timeframe |
DCR without grade 3-4 toxicity was calculated among the BOCR responders and stable patients without grade 3-4 toxicity in the ITT population from the date of randomisation until the documentation of progression or death or first grade 3 or 4 AE.
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No statistical analyses for this end point |
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End point title |
DCR without grade 3-4 neutropenia | ||||||||||||
End point description |
DCR without grade 3-4 neutropenia, defined as the sum of CR, PR and SD without grade 3-4 neutropenia rates, was observed in 35/82 patients (42.7% [95% CI: 31.8, 54.1]) in Arm A and 25/81 patients (30.9% [95% CI: 21.1, 42.1]) in Arm B.
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End point type |
Secondary
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End point timeframe |
DCR without grade 3-4 neutropenia was calculated among the BOCR responders and stable patients without grade 3-4 neutropenia in the ITT population from the date of randomisation until the documentation of progression, first grade 3-4 neutropenia or death.
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No statistical analyses for this end point |
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End point title |
Objective Response Rate (ORR) | ||||||||||||
End point description |
ORR, defined as the sum of CR and PR rates, was observed in 14/82 patients (17.1% [95% CI: 9.7, 27.0]) in Arm A and 17/81 patients (21.0% [95% CI: 12.7, 31.5]) in Arm B.
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End point type |
Secondary
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End point timeframe |
ORR according to investigator was calculated among the BOCR responders (CR and PR) in the ITT population from the date of randomisation until the documentation of progression or death.
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No statistical analyses for this end point |
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End point title |
ORR without grade 3-4 toxicity | ||||||||||||
End point description |
ORR without grade 3-4 toxicity, defined as the sum of CR and PR without grade 3-4 toxicity rates, was observed in 8/82 patients (9.8% [95% CI: 4.3, 18.3]) in Arm A and 6/81 patients (7.4% [95% CI: 2.8, 15.4]) in Arm B.
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End point type |
Secondary
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End point timeframe |
ORR without grade 3-4 toxicity was calculated among the BOCR responders (CR and PR) who had not experienced grade 3-4 toxicity in the ITT population from the date of randomisation until the documentation of progression, first grade 3 or 4 AE or death.
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No statistical analyses for this end point |
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End point title |
ORR without grade 3-4 neutropenia | ||||||||||||
End point description |
ORR without grade 3-4 neutropenia, defined as the sum of CR and PR without grade 3-4 neutropenia rates, was observed in 10/82 patients (12.2% [95% CI: 6.0, 21.3]) in Arm A and 6/81 patients (7.4% [95% CI: 2.8, 15.4]) in Arm B.
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End point type |
Secondary
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End point timeframe |
ORR without grade 3-4 neutropenia was calculated among the BOCR responders (CR and PR) who hadn't experienced grade 3-4 neutropenia in the ITT population from the date of randomisation until the documentation of PD, first grade 3-4 neutropenia or death
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No statistical analyses for this end point |
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End point title |
Duration of response (DOR) | ||||||||||||
End point description |
Overall, for patients who achieved PR (no CR was observed in any arm), 12 (85.7%) patients in Arm A and 10 (58.8%) patients in Arm B experienced disease progression or death. The median DOR was 8.5 months (95% CI: 4.2, 11.4) in Arm A and 9.3 months (95% CI: 6.8, 19.2) in Arm B. The distribution of duration of response was described by treatment arm using Kaplan-Meier methods, reporting estimated median (in months) with 95% CI, 25th and 75th percentiles and Kaplan-Meier estimated probabilities with corresponding 95% CIs at several time points.
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End point type |
Secondary
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End point timeframe |
Duration of response was calculated among the BOCR responders (CR and PR) in the ITT population from the date of randomisation until the documentation of progression or death from any cause, whichever occurred first.
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Attachments |
Duration of response (months) (ITT analysis set) |
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No statistical analyses for this end point |
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End point title |
Time to first response | ||||||||||||
End point description |
Overall, 14 patients in Arm A and 17 patients in Arm B achieved a PR (no CR). The median Time to first response was 2.8 months (95% CI: 1.3, 3.9) in Arm A and 2.8 months (95% CI: 1.4, 4.2) in Arm B. The distribution of Time to first response was described by treatment arm using Kaplan-Meier methods, reporting estimated median (in months) with 95% CI, 25th and 75th percentiles and Kaplan-Meier estimated probabilities with corresponding 95% CIs at several time points.
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End point type |
Secondary
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End point timeframe |
Time to first response, defined as the time from the date of randomisation to the date of first CR or PR after randomisation, whichever occurred first was measured until the documentation of progression or death from any cause, whichever occurred first.
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Attachments |
Time to first response (months) (ITT analysis set) |
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No statistical analyses for this end point |
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End point title |
Duration of stable disease | ||||||||||||
End point description |
A total of 38 patients in Arm A and 42 patients in Arm B achieved SD. Of these, 31 (81.6%) patients in Arm A and 34 (81.0%) patients in Arm B experienced disease progression or death. The median duration of SD was 4.2 months (95% CI: 4.0, 6.7) in Arm A and 5.7 months (95% CI: 5.0, 7.8) in Arm B. The distribution of duration of stable disease was described by treatment arm using Kaplan-Meier methods, reporting estimated median (in months) with 95% CI, 25th and 75th percentiles and Kaplan-Meier estimated probabilities with corresponding 95% CIs at several time points.
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End point type |
Secondary
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End point timeframe |
Duration of Stable Disease was measured from the date of randomisation until the date of PD or death from any cause, whichever occurred first.
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Attachments |
Duration of stable disease (months) (ITT analysis |
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No statistical analyses for this end point |
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End point title |
Progression-free survival (PFS) | ||||||||||||
End point description |
Overall, disease progression or death was reported in 80/82 (97.6%) patients in Arm A and 73/81 (90.1%) patients in Arm B. The median PFS was 4.0 months (95% CI: 2.8, 5.4) in Arm A and 5.6 months (95% CI: 4.4, 7.8) in Arm B. The distribution of progression-free survival was described by treatment arm using Kaplan-Meier methods, reporting estimated median (in months) with 95% CI, 25th and 75th percentiles and Kaplan-Meier estimated probabilities with corresponding 95% CIs at several time points.
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End point type |
Secondary
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End point timeframe |
The progression-free survival (PFS) was measured from randomisation until the first radiographically documented progression of disease or death from any cause, whichever occurred first.
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Attachments |
PFS (months) (ITT analysis set) |
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No statistical analyses for this end point |
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End point title |
Progression-free survival without grade 3-4 toxicity | ||||||||||||
End point description |
Overall, grade 3-4 toxicity, disease progression or death was reported in 77 (93.9%) patients in Arm A and 74 (91.4%) patients in Arm B. The median PFS without grade 3-4 toxicity was 1.7 months (95% CI: 1.4, 2.8) in Arm A and 1.4 months (95% CI: 1.3, 2.1) in Arm B. The distribution of Progression-free survival without grade 3-4 toxicity was described by treatment arm using Kaplan-Meier methods, reporting estimated median (in months) with 95% CI, 25th and 75th percentiles and Kaplan-Meier estimated probabilities with corresponding 95% CIs at several time points.
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End point type |
Secondary
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End point timeframe |
PFS without grade 3-4 toxicity was measured from randomisation until the first radiographically documented progression of disease, first AE with grade 3 or 4 toxicity or death from any cause, whichever occurred first.
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Attachments |
PFS without grade 3-4 toxicity (months) |
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No statistical analyses for this end point |
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End point title |
Progression-free survival without grade 3-4 neutropenia | ||||||||||||
End point description |
Overall, grade 3-4 neutropenia, disease progression or death was reported in 76 (92.7%) patients in Arm A and 70 (86.4%) patients in Arm B. The median PFS without grade 3-4 neutropenia was 2.7 months (95% CI: 1.4, 3.9) in Arm A and 2.1 months (95% CI: 1.4, 2.6) in Arm B. The distribution of Progression-free survival without grade 3-4 neutropenia was described by treatment arm using Kaplan-Meier methods, reporting estimated median (in months) with 95% CI, 25th and 75th percentiles and Kaplan-Meier estimated probabilities with corresponding 95% CIs at several time points.
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End point type |
Secondary
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End point timeframe |
PFS without grade 3-4 neutropenia was measured from randomisation until the first radiographically documented progression of disease, first grade 3 or 4 neutropenia or death from any cause, whichever occurred first.
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Attachments |
Progression-free survival without grade 3-4 neutro |
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No statistical analyses for this end point |
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End point title |
Overall survival (OS) | ||||||||||||
End point description |
Death was reported in 50 (61.0%) patients in Arm A and 42 (51.9%) patients in Arm B. Median OS were 22.3 months (95% CI: 19.0, 27.3) in Arm A and 26.7 months (95% CI: 22.2, 37.8) in Arm B. The distribution of Overall Survival was described by treatment arm using Kaplan-Meier methods, reporting estimated median (in months) with 95% CI, 25th and 75th percentiles and Kaplan-Meier estimated probabilities with corresponding 95% CIs at several time points.
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End point type |
Secondary
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End point timeframe |
Overall survival was measured from the date of randomisation until the date of death, regardless of the cause of death.
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Attachments |
Overall survival (months) (ITT analysis set) |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Any AE that first occurred during the treatment period (i.e. from first study treatment administration date up to last administration date + 30 days) was recorded in the CRF and included in the analysis of AEs (on-study AE).
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Adverse event reporting additional description |
At the cut-off date (07-NOV-2019), 2 patients were still on treatment. Death was reported for 88 patients, while 60 patients were still being followed for survival. Four patients were lost to follow-up. All patients in the safety analysis set received at least one cycle with a median number of cycle of 4.0 (1-41) in Arm A and 7.0 (1-45) in Arm B.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
22.0
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Reporting groups
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Reporting group title |
Arm A: metronomic schedule (Safety analysis set)
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Reporting group description |
All patients who received at least one dose of study drug and with at least one post-baseline safety data were included in the safety analysis set. A total of 82 patients were included in the safety analysis set. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Arm B: weekly schedule (Safety analysis set)
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Reporting group description |
All patients who received at least one dose of study drug and with at least one post-baseline safety data were included in the safety analysis set. A total of 80 patients were included in the safety analysis set. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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05 Nov 2019 |
Considering all data collected during the time period of the study, the sponsor decided to anticipate the end of study and to proceed with the final statistical analysis earlier.
This decision was based on the following considerations observed on September 10th, 2019:
• After 45 months of study duration, among the 165 randomised patients (164 treated), 152 events (progression or death) were observed. For 12 randomised patients, neither disease progression nor death were recorded (1 patient never received the study drug, 3 patients did not yet progress, 4 drop out patients and 4 patients with only non-radiological progression), and 1 patient was removed from clinical database (no local data privacy form available).
• The maturity of PFS data could thus be considered as being reached.
• 85 deaths were observed, and it was estimated that maturity of OS data (i.e. at least 80% of events) would not be reached by the end-of-study (with the current definition in the protocol). The study was not designed to get mature OS data, however the median OS was reached.
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |