Clinical Trial Results:
Cabazitaxel in patients with Recurrent Ovarian Cancer after failure of standard therapy- A phase II trial
|
Summary
|
|
EudraCT number |
2015-002296-18 |
Trial protocol |
DK |
Global end of trial date |
05 Dec 2018
|
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
19 Nov 2020
|
First version publication date |
19 Nov 2020
|
Other versions |
|
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
|
Trial identification
|
|||
Sponsor protocol code |
CaTo-ROC
|
||
|
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT02560337 | ||
WHO universal trial number (UTN) |
- | ||
|
Sponsors
|
|||
Sponsor organisation name |
Vejle Hospital
|
||
Sponsor organisation address |
Beriderbakken 4, Vejle, Denmark,
|
||
Public contact |
Clinical Trial Unit, Vejle Hospital, kfe.onko@rsyd.dk
|
||
Scientific contact |
Clinical Trial Unit, Vejle Hospital, kfe.onko@rsyd.dk
|
||
|
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
|
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
13 May 2019
|
||
Is this the analysis of the primary completion data? |
No
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
05 Dec 2018
|
||
Was the trial ended prematurely? |
No
|
||
|
General information about the trial
|
|||
Main objective of the trial |
The primary objective is to investigate the effect of cabazitaxel in patients with recurrent ovarian cancer.
|
||
Protection of trial subjects |
Infusions and monitorering were performed according to institutional guidelines.
Anamnesis, clinical examination, blood pressure, quality of life and toxicity assessments were performed before each cycle.
Biochemistry with hematology, CA-125, creatinine, Na, K, Mg, Ca, bilirubin, ALAT, alkaline phosphatase, KFNT, LDH was measured before each cycle and hematology weekly for the first cycle.
CT of thorax/abdomen was performed after every 3rd cycle.
|
||
Background therapy |
Premedication: Iv Clemastin 2 mg Iv Solu-Medrol 40 mg Iv Ranitidin 50 mg Antiemetic prophylaxis was given according to institutional guidelines. Primary prophylaxis with granulocyte colony-stimulating factor (G-CSF) was prescribed to all patients on day two of each cycle to reduce the risk of febrile neutropenia. | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
24 Sep 2015
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
|
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Denmark: 26
|
||
Worldwide total number of subjects |
26
|
||
EEA total number of subjects |
26
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
18
|
||
From 65 to 84 years |
8
|
||
85 years and over |
0
|
||
|
|||||||
|
Recruitment
|
|||||||
Recruitment details |
- Danish women with ovarian cancer - Enrollment from September 2015 until november 2018 | ||||||
|
Pre-assignment
|
|||||||
Screening details |
- Platinum resistant ovarian cancer with at least two previous cytostatic regimens or platinum-refractory disease defined as progression while receiving the last line of platinum based therapy or within 4 weeks of last platinum dose. Screened patients: 39 | ||||||
|
Period 1
|
|||||||
Period 1 title |
Overall trial (overall period)
|
||||||
Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
|
||||||
Blinding used |
Not blinded | ||||||
Blinding implementation details |
Not blinded
|
||||||
|
Arms
|
|||||||
|
Arm title
|
Cabazitaxel | ||||||
Arm description |
- | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Cabazitaxel
|
||||||
Investigational medicinal product code |
|||||||
Other name |
|||||||
Pharmaceutical forms |
Concentrate and solvent for solution for infusion
|
||||||
Routes of administration |
Intravenous use
|
||||||
Dosage and administration details |
25 mg/m2 administered as a one hour intravenous infusion on day 1 of 3-week cycles.
|
||||||
|
|||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Overall trial
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
|
End points reporting groups
|
|||
Reporting group title |
Cabazitaxel
|
||
Reporting group description |
- | ||
|
|||||||||
End point title |
The fraction of patients alive and without progression after three months of treatment with cabazitaxel [1] | ||||||||
End point description |
The fraction of patients alive and without progression after three months of treatment with cabazitaxel
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
3 months
|
||||||||
| 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: In this program it is not possible to use statistical analyses for fraction of patients alive at three months. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||||
End point title |
Progression free survival | ||||||||||
End point description |
Progression free survival (PFS)
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Months
|
||||||||||
|
|||||||||||
Attachments |
Untitled (Filename: PFS Eudract..pdf) |
||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Response rate | ||||||||||
End point description |
Patients were evaluable by both Response Evaluation Criteria in Solid Tumors (RECIST1.1) and by GCIG modified criteria for CA125 response,
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
NA
|
||||||||||
|
|||||||||||
Attachments |
Untitled (Filename: Respons rate Eudract..pdf) |
||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||
End point title |
Overall survival | ||||||||
End point description |
Overall survival (OS)
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Months
|
||||||||
|
|||||||||
Attachments |
Untitled (Filename: OS Eudract..pdf) |
||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||
End point title |
Toxicity of the treatment. | ||||||
End point description |
To investigate the potential toxicity of the treatment.
Toxicities were reported and graded using the National Cancer Institute’s Common Toxicity Criteria (NCI-CTC) version 4.0, year 2010.
|
||||||
End point type |
Secondary
|
||||||
End point timeframe |
During treatment
|
||||||
|
|||||||
Attachments |
Untitled (Filename: Toxicities Eudract..pdf) |
||||||
| No statistical analyses for this end point | |||||||
|
|||||||||
End point title |
Quality of life | ||||||||
End point description |
The tool was EORTC QLQ-C30 questionnaire (C29+C30) version 3.0. (19). The recorded
answers were transformed into dimensions ranged 0-100 according to the EORTC scoring instructions.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Global quality of life was assessed before start of treatment, at every response evaluation, and at the end of treatment.
|
||||||||
|
|||||||||
Attachments |
Untitled (Filename: Quality of life Eudract..pdf) |
||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Toxicities were recorded at baseline, before every cycle and 30 days after the first day in the last cycle
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse event reporting additional description |
Toxicities were graded using The National Cancer Institute’s Common Toxicity Criteria (NCI-CTC) version 4.0, year 2010.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
CTCAE | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
4.0
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Toxicity
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Toxicity collected at baseline, before every cycle and 30 days after the first day in the last cycle. Total number of deaths are collected as number of deaths to date (23.10.20) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||
Substantial protocol amendments (globally) |
|||||||
| Were there any global substantial amendments to the protocol? Yes | |||||||
Date |
Amendment |
||||||
03 Apr 2017 |
Initially, the study included two arms; one with cabazitaxel and the other with tocotrienol. At progression or unacceptable toxicity of either of the treatments, cross-over to the other arm was allowed, although the study was not designed to compare the two treatment arms. Tocotrienol failed to reach its primary endpoint and the arm was closed at the time of the interim analysis. The Danish Medicines Agency decided that a new protocol and patient-information were needed. The study continued with a new protokol version 2, date 27.04.2017
|
||||||
Interruptions (globally) |
|||||||
| Were there any global interruptions to the trial? Yes | |||||||
|
|||||||
Limitations and caveats |
|||||||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||||||
| None reported | |||||||
