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NCT00405951 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of Obatoclax Mesylate (GX15-070MS)in Combination With Docetaxel for the Treatment of Non-Small Cell Lung Cancer
A Phase 1 study, sponsored by Gemin X.
- Completed
- Registry status
- Phase 1
- Development phase
- 47
- Enrollment target
NCT00405951: Completed Phase 1 study, sponsored by Gemin X.
NCT00405951 is a Phase 1 study that has completed, run by Gemin X. The registered enrollment target is 47 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00405951, a Phase 1 study, has completed, sponsored by Gemin X.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 47 participants
- Enrollment target
Study Summary
Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogneic signal is present. Obatoclax is designed to restore apoptosis through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process of cell death that is often inhibited in cancer cells. This is a multi-center, open-label, Phase I/II study of obatoclax administered in combination with docetaxel in 3-week cycles to patients with relapsed or refractory Non-Small Cell Lung Cancer. Treatment may be administered on an outpatient basis. No investigation or commercial agents or therapies other than those described herein may be administered with the intent to treat the patient's malignancy. Supportive care measures including those directed at controlling symptoms resulting from Non-Small Cell Lung Cancer are allowed.
Primary Outcome
Determine the response rate to obatoclax in combination with docetaxel and characterize the safety profile.; Determine the steady-state pharmacokinetic parameters and pharmacodynamic response.
Interventions
- DRUG Docetaxel
- DRUG Obatoclax mesylate 250 ml
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2006-10 |
| Est. Completion | 2009-09 |
| Phase | Phase 1 |
What the finished NCT00405951 record still lists
NCT00405951 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower).
The record links to 0 conditions, and to 2 interventions - of which Docetaxel is the first listed.
NCT00405951 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00405951 about?
NCT00405951 is a clinical study titled "Safety and Efficacy of Obatoclax Mesylate (GX15-070MS)in Combination With Docetaxel for the Treatment of Non-Small Cell Lung Cancer". Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogneic signal is present. Obatoclax is designed to restore apoptosis through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process of cell death that is often...
What is the current status of trial NCT00405951?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2006-10. Estimated completion is 2009-09.
What interventions are being tested in trial NCT00405951?
The interventions under investigation include: Docetaxel (DRUG), Obatoclax mesylate 250 ml (DRUG).
Who is sponsoring clinical trial NCT00405951?
This trial is sponsored by Gemin X, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00405951's enrollment target sits among peer trials
47 1053rd of 2000 higher than 943 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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