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NCT01630733 · ClinicalTrials.gov registry record · Phase 3
A Multinational, Randomized, Open-Label Study of Custirsen In Patients With Advanced or Metastatic (Stage IV) Non-Small Cell Lung Cancer
A Phase 3 study, sponsored by Achieve Life Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 664
- Enrollment target
NCT01630733: Completed Phase 3 study, sponsored by Achieve Life Sciences.
NCT01630733 is a Phase 3 study that has completed, run by Achieve Life Sciences. The registered enrollment target is 664 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01630733, a Phase 3 study, has completed, sponsored by Achieve Life Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 664 participants
- Enrollment target
Study Summary
The primary objective of the study is to compare overall survival of participants randomized to receiving custirsen in combination with docetaxel with participants randomized to receive docetaxel alone.
Primary Outcome
Overall survival time is defined as the number of days from the date of randomization until the date of death from any cause. Participants who did not achieve the event (death) at the time of the analysis or who dropped out before completing the survival follow-up period will be censored at the date they were last known to be alive (i.e., right censored). Partial or missing dates of death or last contact were imputed.
Interventions
- DRUG Docetaxel
- DRUG Custirsen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 664 participants |
| Start Date | 2012-10-24 |
| Est. Completion | 2016-11-17 |
| Phase | Phase 3 |
What the finished NCT01630733 record still lists
NCT01630733 is an interventional study that assigns participants to a tested intervention. The registered 664 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% lower).
The record links to 0 conditions, and to 2 interventions - of which Docetaxel is the first listed.
NCT01630733 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01630733 about?
NCT01630733 is a clinical study titled "A Multinational, Randomized, Open-Label Study of Custirsen In Patients With Advanced or Metastatic (Stage IV) Non-Small Cell Lung Cancer". The primary objective of the study is to compare overall survival of participants randomized to receiving custirsen in combination with docetaxel with participants randomized to receive docetaxel alone.
What is the current status of trial NCT01630733?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 664 participants. The study started on 2012-10-24. Estimated completion is 2016-11-17.
What interventions are being tested in trial NCT01630733?
The interventions under investigation include: Docetaxel (DRUG), Custirsen (DRUG).
Who is sponsoring clinical trial NCT01630733?
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 NCT01630733's enrollment target sits among peer trials
664 553rd of 2000 higher than 1,448 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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