Trials / Completed
CompletedNCT00704158
Study of CR011-vcMMAE to Treat Locally Advanced or Metastatic Breast Cancer
A Phase I/II Study of CR011-vcMMAE in Patients With Locally Advanced or Metastatic Breast Cancer
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- CuraGen Corporation · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the safety and tolerability of CR011-vcMMAE in patients with locally advanced and metastatic breast cancer. CR011-vcMMAE will be administered intravenously (IV) once every 3 weeks (q3w) to cohorts of 3-6 patients to confirm the maximum tolerated dose (MTD) in breast cancer patients. Once the MTD is confirmed, up to 25 patients with locally advanced or metastatic breast cancer will be enrolled into the Phase II portion of the trial to further evaluate the safety and efficacy of CR011-vcMMAE.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CR011-vcMMAE | administered as an intravenous infusion on Day 1 of a 21 day cycle. |
Timeline
- Start date
- 2008-06-01
- Primary completion
- 2010-11-01
- Completion
- 2011-06-01
- First posted
- 2008-06-24
- Last updated
- 2015-02-19
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00704158. Inclusion in this directory is not an endorsement.