Study to Compare the Efficacy and Safety of Olaparib When Given in Combination With Carboplatin and Paclitaxel, Compared With Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

A Phase II Open Label Randomised Comparative Multicentre Study to Compare the Efficacy and Tolerability of Olaparib in Combination With Paclitaxel and Carboplatin Versus Paclitaxel and Carboplatin Alone in Patients With Platinum Sensitive Advanced Serous Ovarian Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01081951
• Other study ID #: D0810C00041
• Secondary ID: 2009-015970-36
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: February 4, 2010
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the efficacy of olaparib in combination with paclitaxel and carboplatin (AUC4) when compared with carboplatin (AUC6) and paclitaxel alone in patients with advanced ovarian cancer.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 162
• Est. completion date: December 31, 2024
• Est. primary completion date: October 10, 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 125 Years

Eligibility

Inclusion Criteria:

• Diagnosed with serous ovarian cancer

• Patients who have received no more than 3 previous platinum containing treatments and were progression free for at least 6 months following the end of the last platinum treatment

• At least one lesion that is suitable for accurate repeated measurements

Exclusion Criteria:

• Patients receiving any systemic anticancer chemotherapy, radiotherapy (except palliative) within two weeks from the last dose prior to study treatment

• Hypersensitivity to pre medications required for treatment with paclitaxel/carboplatin

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• olaparib
Tablets Oral BID
• paclitaxel
175mg/m2 iv for 6 cycles (18 weeks) day 1 of 21 day cycle
• carboplatin
AUC6 iv for 6 cycles (18 weeks) day 1 of 21 day cycle
• paclitaxel
175mg/m2 iv for up to 6 cycles (18 weeks)
• Drug: carboplatin
AUC4 iv for up to 6 cycles (18 weeks)

Locations

Country	Name	City	State
Australia	Research Site	Parkville
Australia	Research Site	Randwick
Belgium	Research Site	Brussels
Belgium	Research Site	Leuven
Belgium	Research Site	Namur
Belgium	Research Site	Wilrijk
Canada	Research Site	Hamilton	Ontario
Canada	Research Site	Quebec
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Vancouver	British Columbia
Czechia	Research Site	Brno
Czechia	Research Site	Hradec Kralove
Czechia	Research Site	Olomouc
Germany	Research Site	Essen
Germany	Research Site	Frankfurt
Germany	Research Site	Hamburg
Germany	Research Site	München
Germany	Research Site	Solingen
Italy	Research Site	Genova
Italy	Research Site	Milan
Italy	Research Site	Monza
Italy	Research Site	Torino
Japan	Research Site	Chuo-ku
Japan	Research Site	Fukuoka-shi
Japan	Research Site	Matsuyama-shi
Japan	Research Site	Morioka-shi
Japan	Research Site	Shinjuku-ku
Japan	Research Site	Yamagata-shi
Netherlands	Research Site	Amsterdam
Netherlands	Research Site	Nijmegen
Netherlands	Research Site	Rotterdam
Peru	Research Site	Lima
Peru	Research Site	Lima
Spain	Research Site	Madrid
Spain	Research Site	Valencia
United Kingdom	Research Site	Birmingham
United Kingdom	Research Site	Edinburgh
United States	Research Site	Boston	Massachusetts
United States	Research Site	New York	New York
United States	Research Site	Orlando	Florida
United States	Research Site	Portland	Oregon
United States	Research Site	West Hollywood	California

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Czechia,  Germany,  Italy,  Japan,  Netherlands,  Peru,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS)	PFS (based on independent central review) was defined as the time from randomisation until objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST) v1.1 (=20% increase in the sum of the diameters of target lesions from minimum, clinically significant progression in non-target lesions or the presence of a new lesion) or death (by any cause in the absence of progression).	Radiologic scans performed at weeks 9 and 18 (+/-1 week) and every 12 weeks thereafter relative to the date of randomisation until the primary analysis (approximately 20 months)
Secondary	Overall Survival (OS)	OS was defined as the time from randomisation until death by any cause. Patients who had not died at the time of analysis were censored at the last date the patient was known to be alive.	Following disease progression, patients will be contacted every 12 weeks to assess survival status until the final analysis (approximately 50 months)
Secondary	Percentage Change in Tumour Size	The total tumour size was defined as the sum of the longest diameters of the target lesions. At week 9, the percentage change in tumour size was calculated as [(week 9 sum of target lesions - baseline sum of target lesions)/baseline sum of target lesions]*100 for each patient. Imputations were used for missing data where possible.	Week 9 (+/- 1 week)

External Links

•   CSR-D0810C00041.pdf
•   Redacted Protocol