Clinical Trial Results:
A Phase II, Open-Label Trial of Bortezomib (Velcade®) in Combination with Gemcitabine and Cisplatin in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer.
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Summary
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EudraCT number |
2006-004963-68 |
Trial protocol |
GR |
Global end of trial date |
25 Oct 2013
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Results information
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Results version number |
v1(current) |
This version publication date |
10 Jul 2019
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First version publication date |
10 Jul 2019
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Other versions |
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Summary report(s) |
Bortezomib Abstract |
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 |
26866138-LUC-2006
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
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WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
Hellenic Oncology Research Group
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Sponsor organisation address |
Gr. Theologou 5, Athens, Greece, 11471
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Public contact |
Evagelia Ageli, Hellenic Oncology Research Group, secretary@horg.gr
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Scientific contact |
Vasilis Georgoulias, Hellenic Oncology Research Group, georgouliasv@gmail.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 |
13 Dec 2013
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
25 Oct 2013
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Global end of trial reached? |
Yes
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Global end of trial date |
25 Oct 2013
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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 |
The primary objective of this study is to establish the objective response rate (complete response [CR] + partial response [PR]) following treatment with VELCADE in combination with cisplatin plus gemcitabine in patients with locally advanced Stage IIIb not amenable to curative treatment or metastatic (stage IV) non-small cell lung cancer (NSCLC) who have not received prior antineoplastic therapy for advanced disease.
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Protection of trial subjects |
none
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Background therapy |
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Evidence for comparator |
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Actual start date of recruitment |
07 Jul 2009
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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 |
Greece: 53
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Worldwide total number of subjects |
53
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EEA total number of subjects |
53
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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) |
18
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From 65 to 84 years |
35
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85 years and over |
0
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Recruitment
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Recruitment details |
Pts with stage IIIB or metastatic (stage IV) NSCLC , age ≥18 years, measurable disease according to RECIST vrs 1.0, life expectancy >3 months, and ECOG performance status of 0–1. | ||||||||||||||||
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Pre-assignment
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Screening details |
One prior line of anti-neoplastic therapy allowed if given as adjuvant or neo-adjuvant, at least 6 months earlier. | ||||||||||||||||
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Period 1
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Period 1 title |
Entire trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||
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Arms
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Arm title
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Intent to treat subjects | ||||||||||||||||
Arm description |
One arm with all subjects participating into the Trial and have signed ICF | ||||||||||||||||
Arm type |
Experimental | ||||||||||||||||
Investigational medicinal product name |
Bortezomib
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Investigational medicinal product code |
179324-69-7
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Other name |
velcade
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Pharmaceutical forms |
Powder for solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
1 mg/m2 i.v. on days 1 and 8, and starting on day 21 (cycle 2), bortezomib (days 1 and 8) in combination with gemcitabine 1000 mg/m2, (days 1 and 8), and cisplatin 70 mg/m2 (day 1) in cycles of 21 days. Up to 8 cycles of combination therapy could be administered; single-agent bortezomib was continued until disease progression or unacceptable toxicity.
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Baseline characteristics reporting groups
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Reporting group title |
Entire trial
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Reporting group description |
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Subject analysis sets
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Subject analysis set title |
Efficacy of Bortezomib
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Subject analysis set type |
Modified intention-to-treat | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Pts with histologically or cytologically confirmed, locally advanced (stage IIIB) or metastatic (stage IV) NSCLC. Prior systemic anti-neoplastic therapy for stage IIIB/IV disease was not allowed (one prior line was allowed if given as adjuvant or neo-adjuvant therapy at least 6 months earlier). Age ≥18 years with measurable disease according to RECIST version 1.1 Criteria, life expectancy >3 months, and ECOG performance status of 0–1. All patients treated at least for 1 cycle with the IMP and evaluated according to RECIST criteria version 1.1, were included into this analysis set.
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End points reporting groups
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Reporting group title |
Intent to treat subjects
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Reporting group description |
One arm with all subjects participating into the Trial and have signed ICF | ||
Subject analysis set title |
Efficacy of Bortezomib
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Subject analysis set type |
Modified intention-to-treat | ||
Subject analysis set description |
Pts with histologically or cytologically confirmed, locally advanced (stage IIIB) or metastatic (stage IV) NSCLC. Prior systemic anti-neoplastic therapy for stage IIIB/IV disease was not allowed (one prior line was allowed if given as adjuvant or neo-adjuvant therapy at least 6 months earlier). Age ≥18 years with measurable disease according to RECIST version 1.1 Criteria, life expectancy >3 months, and ECOG performance status of 0–1. All patients treated at least for 1 cycle with the IMP and evaluated according to RECIST criteria version 1.1, were included into this analysis set.
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End point title |
Objective Response Rate (ORR) [1] | |||||||||
End point description |
Objective response rate (ORR) is defined as the percentage (%) of patients that achieved Complete response (CR) or Partial response (PR) to the treatment, as measured by RECIST 1.1 CRITERIA. ORR= (CR+PR)/total number of patients, expressed as % percentage.
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End point type |
Primary
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End point timeframe |
July 2009 - April 2013
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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 2 step Simon's design that yields a type I error rate of 0.05 and power of 80% when the true overall response rate is 40% was used. The null hypothesis will be rejected if 12 or more responses are observed in 43 evaluable pts. This is an one arm trial that compares ORR with bibliographic data. The system does keeps asking for comparison group. |
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End point title |
Progression free survival (PFS) | ||||||||||||
End point description |
PFS was measured from the first day of treatment until the day of the first evidence of disease progression or death from any cause.
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End point type |
Secondary
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End point timeframe |
July 2009 - April 2013
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Overall Survival (OS) | ||||||||||||
End point description |
OS was measured from the first day of treatment until death or last follow-up.
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End point type |
Secondary
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End point timeframe |
July 2009 -April 2013
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Attachments |
OS Kaplan Meier |
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Adverse events information
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Timeframe for reporting adverse events |
July 2009 - April 2013
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
16.0
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Reporting groups
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Reporting group title |
Bortezomib treated patients
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Reporting group description |
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| Frequency threshold for reporting non-serious adverse events: 0.01% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
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 | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/26994909 |
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