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NCT00760929 · ClinicalTrials.gov registry record · Phase 2
A Study of the Effect of R1507 in Combination With Tarceva (Erlotinib) on Progression-Free Survival in Patients With Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC).
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 2
- Development phase
- 171
- Enrollment target
NCT00760929: Clinical Trial Phase 2 study, sponsored by Hoffmann-La Roche.
NCT00760929 is a Phase 2 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 171 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00760929, a Phase 2 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 171 participants
- Enrollment target
Study Summary
This 4 arm study in patients with advanced Stage IIIb/IV non-small cell cancer (NSCLC) who failed at least one standard chemotherapy regimen will determine the proportion of patients with progression-free survival at 12 weeks following combination therapy with R1507 and Tarceva or placebo and Tarceva. Patients will be randomized to one of four treatment arms to receive R1507 (9mg/kg iv) or placebo weekly or R1507 (16mg/kg iv) or placebo every 3 weeks. Tarceva (150mg oral daily) will be administered in all treatment arms. Other disease-related endpoints including overall survival, objective response rate, time to response, time to progressive disease and duration of response will also be evaluated. The anticipated time on study treatment is 1-2 years, and the target sample size is \<500 individuals.
Primary Outcome
PFS was defined as the time at which half of the participants have progressed (progressive disease \[PD\]) based on RECIST tumor response criteria or died from any cause, whichever occurred first. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Parti
Interventions
- DRUG Placebo
- DRUG RG1507
- DRUG erlotinib [Tarceva]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 171 participants |
| Start Date | 2008-11-10 |
| Est. Completion | 2010-06-25 |
| Phase | Phase 2 |
Why NCT00760929 stopped before completion
NCT00760929 is an interventional study that assigns participants to a tested intervention. The registered 171 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00760929 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00760929 about?
NCT00760929 is a clinical study titled "A Study of the Effect of R1507 in Combination With Tarceva (Erlotinib) on Progression-Free Survival in Patients With Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC).". This 4 arm study in patients with advanced Stage IIIb/IV non-small cell cancer (NSCLC) who failed at least one standard chemotherapy regimen will determine the proportion of patients with progression-free survival at 12 weeks following combination therapy with R1507 and Tarceva or placebo and Tarcev...
What is the current status of trial NCT00760929?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 171 participants. The study started on 2008-11-10. Estimated completion is 2010-06-25.
What interventions are being tested in trial NCT00760929?
The interventions under investigation include: Placebo (DRUG), RG1507 (DRUG), erlotinib [Tarceva] (DRUG).
Who is sponsoring clinical trial NCT00760929?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00760929's enrollment target sits among peer trials
171 398th of 2000 higher than 1,602 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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