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NCT01435369 · ClinicalTrials.gov registry record · Phase 2
Safety, Tolerability and Efficacy Study of the Monoclonal Antibody, CT-011, in Patients With Metastatic Melanoma
A Phase 2 study, sponsored by Medivation.
- Completed
- Registry status
- Phase 2
- Development phase
- 103
- Enrollment target
NCT01435369: Completed Phase 2 study, sponsored by Medivation.
NCT01435369 is a Phase 2 study that has completed, run by Medivation. The registered enrollment target is 103 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01435369, a Phase 2 study, has completed, sponsored by Medivation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 103 participants
- Enrollment target
Study Summary
The purpose of this research study is to see if the study drug, CT-011, is safe to give and if it helps people with melanoma that has spread to other areas of their body. CT-011 is a monoclonal antibody. Monoclonal antibodies are a type of drug that is typically given by infusion into a vein (intravenously). Monoclonal antibodies are antibodies made in a lab instead of by the immune system which then recruit the immune system to help fight cancer cells. All final eligible subjects will receive an intravenous infusion of CT-011. This study will test two dose levels of the study drug: Group 1: Patients in this group will be given the study drug at dose level 1 (1.5 mg/kg). Group 2: Patients in this group will be given the study drug at dose level 2 (6.0 mg/kg). Each group will be given the study drug through an IV (a needle put into a vein in the arm) on day 1. After day 1, the study drug will be given every other week. Patients may be given a total of up to 27 study drug infusions for about 12 months while they are in the study. Approximately 100 patients will participate in this study.
Interventions
- DRUG CT-011
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2011-11 |
| Est. Completion | 2013-08 |
| Phase | Phase 2 |
What the finished NCT01435369 record still lists
NCT01435369 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 1 intervention - of which CT-011 is the first listed.
NCT01435369 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01435369 about?
NCT01435369 is a clinical study titled "Safety, Tolerability and Efficacy Study of the Monoclonal Antibody, CT-011, in Patients With Metastatic Melanoma". The purpose of this research study is to see if the study drug, CT-011, is safe to give and if it helps people with melanoma that has spread to other areas of their body. CT-011 is a monoclonal antibody. Monoclonal antibodies are a type of drug that is typically given by infusion into a vein (intrav...
What is the current status of trial NCT01435369?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 103 participants. The study started on 2011-11. Estimated completion is 2013-08.
What interventions are being tested in trial NCT01435369?
The interventions under investigation include: CT-011 (DRUG).
Who is sponsoring clinical trial NCT01435369?
This trial is sponsored by Medivation, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01435369's enrollment target sits among peer trials
103 664th of 2000 higher than 1,333 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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