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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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival (PFS)

Outcome Description:

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).

Outcome Time Frame:

Radiologic scans performed at weeks 9 and 18 (+/-1 week) and every 12 weeks therafter relative to the date of randomisation

Safety Issue:

No

Principal Investigator

Jane Robertson, BSc, MBCHB, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

D0810C00041

NCT ID:

NCT01081951

Start Date:

February 2010

Completion Date:

June 2013

Related Keywords:

  • Ovarian Cancer
  • Poly(ADP ribose)
  • polymerisation (PARP)
  • Platinum sensitive
  • Advanced Serous Ovarian cancer
  • olaparib
  • PARP inhibitors
  • Platinum Sensitive Advanced Serous Ovarian Cancer
  • Ovarian Neoplasms

Name

Location
Research Site Anaheim, California  
Research Site Boca Raton, Florida  
Research Site Bloomington, Indiana  
Research Site Beverly, Massachusetts  
Research Site Albany, New York  
Research Site Bend, Oregon