Trial information
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 type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
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:
- histologically confirmed ovarian, primary peritoneal, or fallopian tube cancer;
- only 1 previous regimen, which must be platinum-based;
- platinum-sensitive disease which is defined by a progression-free interval of greater than 6 months after completion of platinum-based chemotherapy.
Exclusion criteria:
- previous radiotherapy;
- previous treatment with an anti-cancer vaccine or any targeted therapy;
- major surgery or traumatic injury within 4 weeks of study;
- history or evidence of central nervous system metastases.
Gender: Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: December, 2005
Trial registration date: 10/26/2005
Date last updated: 12/2/2008
Link to trial result
This trial is being conducted at the following locations:
Belgium
Canada
- Calgary, AB
- Kelowna, BC
- Vancouver, BC
Hungary
Italy
Netherlands
Poland
Russian Federation
- Kazan
- Moscow
- St Petersburg
- Tomsk
Spain
- Barcelona
- Madrid
- Valencia
United Kingdom
- Birmingham
- London
- Manchester
- Plymouth
- Sutton
- Yeovil
