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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 is a Phase 2 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 171 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00760929
The ClinicalTrials.gov registry entry for NCT00760929 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 171 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00760929 reports 0 study locations.
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.
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