Trials / Terminated
TerminatedNCT00051584
Safety/Efficacy Study of SGN-15 (Antibody-Drug Conjugate) Combined With Gemcitabine in Patients With Ovarian Cancer
A Phase II Study of SGN-15 (cBR96 - Doxorubicin Immunoconjugate) Combined With Gemzar® Versus Single-Agent Gemzar® in Patients With Advanced Ovarian Cancer
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (planned)
- Sponsor
- Seagen Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label, randomized phase II trial comparing treatment with a monoclonal antibody (mAb) drug immunoconjugate, SGN-15, administered weekly in combination with weekly Gemzar® (Gemcitabine) to treatment with Gemzar® alone. The primary objectives of this study are to determine the toxicity and safety profile of the combination of SGN-15 and Gemzar®, to estimate the clinical response rate and to estimate the duration of response of this combination therapy administered to patients with advanced ovarian cancer, compared to treatment with Gemzar® alone.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SGN-15 (cBR96-Doxorubicin Immunoconjugate) | |
| DRUG | Gemzar (Gemcitabine) |
Timeline
- Completion
- 2003-05-01
- First posted
- 2003-01-15
- Last updated
- 2011-10-24
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00051584. Inclusion in this directory is not an endorsement.