Trial Information

Summary: A Study to Evaluate the Effect of the Combination of Pertuzumab With Carboplatin-Based Standard Chemotherapy in Patients With Recurrent Ovarian Cancer

Status: Recruiting

Protocol Number: BO17931

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open-label study of the effect of Omnitarg in combination with carboplatin-based chemotherapy versus carboplatin-based therapy alone on treatment response in patients with platinum-sensitive recurrent ovarian cancer

Brief Summary: This study will evaluate the efficacy and safety of pertuzumab in combination with carboplatin-based standard chemotherapy in patients with platinum-sensitive recurrent ovarian cancer. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals. Target sample size is 148.

Study Phase: II

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Open Label
• Control: Active
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

Condition: Ovarian Cancer

Intervention Type: Drug

Intervention Name: pertuzumab

Primary Outcome: 1. Efficacy: Response Evaluation Criteria in Solid Tumors

Key Secondary Outcomes: 1. Safety: Adverse events, laboratory parameters

Inclusion Criteria:

Exclusion Criteria:

Gender: Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: December, 2005

Trial Registration Date: 10/26/2005

Date Last Updated: 10/17/2008

Link To Trial Results

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Trial listings updated: November 17, 2008 at 2:30:28 PM