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NCT00138658 · ClinicalTrials.gov registry record · Phase 1
A Study of OGX-011/Gemcitabine/Platinum-Based Regimen in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)
A Phase 1 study, sponsored by Achieve Life Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 85
- Enrollment target
NCT00138658: Completed Phase 1 study, sponsored by Achieve Life Sciences.
NCT00138658 is a Phase 1 study that has completed, run by Achieve Life Sciences. The registered enrollment target is 85 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00138658, a Phase 1 study, has completed, sponsored by Achieve Life Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 85 participants
- Enrollment target
Study Summary
This clinical study will help determine if giving OGX-011 (custirsen sodium) in combination with gemcitabine (GEM) and cisplatin (CIS) or carboplatin (CARB) is a safe and effective treatment for patients with lung cancer. This study will help to assess the safety and anti-tumor effect of OGX-011 when given to patients in combination with GEM and CIS/CARB.
Primary Outcome
Per RECIST Criteria V 1.0 and based on radiographic evaluations a subject was defined as having an objective response (OR) if the subject achieved either a confirmed partial response (PR) or confirmed complete response (CR). The evaluations were conducted after every two cycles of treatment for a maximum of 6 cycles. CR: disappearance of clinical/radiological evidence of tumor. PR: \>= 30% decrease in the sum of the longest diameter of target lesions. SD: did not fulfill the criteria for CR
Interventions
- DRUG custirsen sodium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2004-11 |
| Est. Completion | 2010-03 |
| Phase | Phase 1 |
What the finished NCT00138658 record still lists
NCT00138658 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% higher).
The record links to 0 conditions, and to 1 intervention - of which custirsen sodium is the first listed.
NCT00138658 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00138658 about?
NCT00138658 is a clinical study titled "A Study of OGX-011/Gemcitabine/Platinum-Based Regimen in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)". This clinical study will help determine if giving OGX-011 (custirsen sodium) in combination with gemcitabine (GEM) and cisplatin (CIS) or carboplatin (CARB) is a safe and effective treatment for patients with lung cancer. This study will help to assess the safety and anti-tumor effect of OGX-011 whe...
What is the current status of trial NCT00138658?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 85 participants. The study started on 2004-11. Estimated completion is 2010-03.
What interventions are being tested in trial NCT00138658?
The interventions under investigation include: custirsen sodium (DRUG).
Who is sponsoring clinical trial NCT00138658?
This trial is sponsored by Achieve Life Sciences, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00138658's enrollment target sits among peer trials
85 656th of 2000 higher than 1,342 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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