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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 is a Phase 2 study that has completed, run by Medivation. The registered enrollment target is 103 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01435369
The ClinicalTrials.gov registry entry for NCT01435369 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 103 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medivation, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CT-011 is the first listed.
NCT01435369 reports 0 study locations.
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.
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