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NCT01497470 · ClinicalTrials.gov registry record · Phase 1
A Clinical Study in Cancer Patients to Investigate the Potential Impact of Custirsen, on the Blood Levels of the Chemotherapeutic Drug, Paclitaxel, When Given Together as Part of a Treatment Regimen
A Phase 1 study, sponsored by Achieve Life Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT01497470: Completed Phase 1 study, sponsored by Achieve Life Sciences.
NCT01497470 is a Phase 1 study that has completed, run by Achieve Life Sciences. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01497470, a Phase 1 study, has completed, sponsored by Achieve Life Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
The primary goal of this study is to determine if custirsen has an effect on the way the body distributes and gets rid of paclitaxel, the standard administered chemotherapy. The study will also evaluate if custirsen influences the way the body distributes and gets rid of carboplatin (another standard administered chemotherapy) and will measure custirsen blood levels in this cancer population. Finally, the study will evaluate the safety and tolerability of adding custirsen to the standard paclitaxel/carboplatin chemotherapy.
Primary Outcome
The maximum peak concentration of paclitaxel after administration.
Interventions
- DRUG Custirsen, paclitaxel and carboplatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2012-04 |
| Est. Completion | 2013-10 |
| Phase | Phase 1 |
What the finished NCT01497470 record still lists
NCT01497470 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 1 intervention - of which Custirsen, paclitaxel and carboplatin is the first listed.
NCT01497470 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01497470 about?
NCT01497470 is a clinical study titled "A Clinical Study in Cancer Patients to Investigate the Potential Impact of Custirsen, on the Blood Levels of the Chemotherapeutic Drug, Paclitaxel, When Given Together as Part of a Treatment Regimen". The primary goal of this study is to determine if custirsen has an effect on the way the body distributes and gets rid of paclitaxel, the standard administered chemotherapy. The study will also evaluate if custirsen influences the way the body distributes and gets rid of carboplatin (another standar...
What is the current status of trial NCT01497470?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2012-04. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01497470?
The interventions under investigation include: Custirsen, paclitaxel and carboplatin (DRUG).
Who is sponsoring clinical trial NCT01497470?
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 NCT01497470's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 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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