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NCT00065429 · ClinicalTrials.gov registry record · Phase 1
Safety Study Using Weekly Infusions of BB-10901 in Patients With Small Cell Lung Cancer
A Phase 1 study, sponsored by ImmunoGen.
- Completed
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
NCT00065429: Completed Phase 1 study, sponsored by ImmunoGen.
NCT00065429 is a Phase 1 study that has completed, run by ImmunoGen. The registered enrollment target is 64 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00065429, a Phase 1 study, has completed, sponsored by ImmunoGen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
Study Summary
This study was a Phase I/II trial primarily focused on efficacy of BB-10901 in relapsed small cell lung cancer and other solid tumors.
Primary Outcome
Dose limiting toxicities graded according to common terminology criteria for advers events, version 2.0 and defined as AEs (probably/definitely related to study drug) meeting the NCI CTC criteria, assessed on the basis of the first cycle of therapy (4 weeks of weekly dosing/2 week fu): Hematologic Tox (Grade 4 neutropenia ≥ 5 days, Grade 4 thrombocytopenia, neutropenic infection); Non-Hem Toxicity: (Any grade 3 or 4 non-hematologic toxicity, excluding nausea, vomiting, diarrhea and alopecia); To
Interventions
- DRUG BB-10901
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2003-04 |
| Est. Completion | 2008-12 |
| Phase | Phase 1 |
What the finished NCT00065429 record still lists
NCT00065429 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which BB-10901 is the first listed.
NCT00065429 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00065429 about?
NCT00065429 is a clinical study titled "Safety Study Using Weekly Infusions of BB-10901 in Patients With Small Cell Lung Cancer". This study was a Phase I/II trial primarily focused on efficacy of BB-10901 in relapsed small cell lung cancer and other solid tumors.
What is the current status of trial NCT00065429?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2003-04. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00065429?
The interventions under investigation include: BB-10901 (DRUG).
Who is sponsoring clinical trial NCT00065429?
This trial is sponsored by ImmunoGen, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00065429's enrollment target sits among peer trials
64 808th of 2000 higher than 1,181 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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