Safety/Efficacy Study of SGN-15 (Antibody-Drug Conjugate) Combined With Gemcitabine in Patients With Ovarian Cancer

Seagen

Status and phase

Terminated

Phase 2

Conditions

Ovarian Neoplasms

Treatments

Drug: SGN-15 (cBR96-Doxorubicin Immunoconjugate)

Drug: Gemzar (Gemcitabine)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00051584

SG015-0003

Details and patient eligibility

About

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.

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Brief Overview of Inclusion Criteria:

Patients must have pathologically confirmed ovarian cancer, which is advanced or recurrent carcinoma, who have failed at least two, but no more than three prior therapies for metastatic disease
Patients must have > 20% Lewis-y antigen expression documented by immunohistochemistry
LVEF > 50% by echo or MUGA
Must be platinum resistant as defined by:
- Progression while on initial platinum therapy or
- Progression while on retreatment with initial platinum regimen or
- Relapse < 6 months after initial therapy

Brief Overview of Exclusion Criteria:

Patients who have had prior therapy with Gemzar®
Cumulative anthracycline exposure > 300 mg/m2
More than three prior chemotherapy regimens for ovarian cancer (Retreatment with Taxane/Platinum after initial combination is considered only one regimen)