Trials / Completed
CompletedNCT00306631
A Study to Determine the Antitumor Activity and Evaluate the Safety of MKC-1
A Phase 2 Study of Oral MKC-1 Administered Twice Daily for 14 Consecutive Days Every 4 Weeks in Patients With Advanced or Metastatic Breast Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 65 (actual)
- Sponsor
- CASI Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase 2 study will determine the antitumor activity, based on the objective rate, of oral MKC-1, administered twice daily for 14 consecutive days every 4 weeks, in patients with advanced or metastatic breast carcinoma. The study will also evaluate the safety and response duration in patients, time to tumor progression, and overall survival in patients following MKC-1 therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MKC-1 | Oral capsules, 30 mg and 100 mg capsule strengths; administered twice daily for 14 days in a 28 day cycle |
Timeline
- Start date
- 2006-01-01
- Primary completion
- 2008-04-01
- Completion
- 2008-11-01
- First posted
- 2006-03-24
- Last updated
- 2009-06-03
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00306631. Inclusion in this directory is not an endorsement.