Olaparib Treatment in relapsed germline Breast Cancer susceptibility gene (BRCA) Mutated Ovarian Cancer Patients who have progressed at least 6 months after last platinum treatment and have received at least 2 prior platinum treatments - SOLO3

Study identifier:D0816C00010

ClinicalTrials.gov identifier:NCT02282020

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase III, Open Label, Randomised, Controlled, Multi-centre Study to assess the efficacy and safety of Olaparib Monotherapy versus Physician’s Choice Single Agent Chemotherapy in the Treatment of Platinum Sensitive Relapsed Ovarian Cancer in Patients carrying germline BRCA1/2 Mutations.

Medical condition

relapsed ovarian cancer, BRCA mutation, Platinum sensitivity

Phase

Phase 3

Healthy volunteers

Study drug

OLAPARIB, Single agent chemotherapy

Sex

Female

Actual Enrollment

266

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 06 Feb 2015

Primary Completion Date: 10 Oct 2018

Study Completion Date: 19 Jul 2022

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: -
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Jul 2022 by AstraZeneca

Collaborators

Myriad Genetics - BRACAnalysis test for FDA Premarket Approval (PMA), Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Inclusion and exclusion criteria

Inclusion Criteria

- Patients must be ≥ 18 years of age
- Patients with histologically diagnosed relapsed high grade serous ovarian cancer (including primary peritoneal and/or fallopian tube cancer) or high grade endometrioid cancer. Patients are eligible to undergo BRCA testing even if they have not yet had recurrence or progression of disease >6 months (>/=183 days) after completion of their last platinum therapy.
- Documented germline mutation in Breast Cancer susceptibility genes: BRCA1 and/or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)
- At least one lesion that can be accurately assessed at baseline by CT/MRI and is suitable for repeated assessment.
- Patients must have received at least 2 prior platinum based lines of chemotherapy - Patients must be partially platinum sensitive or platinum sensitive
- Patients must be suitable to start treatment with single agent chemotherapy based on physician’s choice
- Patients must have normal organ and bone marrow function measured within 28 days of randomisation,
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Patients must have a life expectancy ≥ 16 weeks
- Formalin fixed, paraffin embedded tumour sample from the primary or recurrent cancer must be available for central testing.

Exclusion Criteria

- BRCA 1 and/or BRCA2 mutations that are considered to be non detrimental
- Exposure to any investigational product within 30 days or 5 half lives (whichever is longer) prior to randomisation
- Any previous treatment with a Polyadenosine 5'diphosphoribose polymerisation (PARP) inhibitor, including olaparib.
- Patients who have platinum resistant or refractory disease
- Patients receiving any systemic chemotherapy within 3 weeks prior to first dose of study treatment
- Previous single agent exposure to the selected chemotherapy regimen for randomisation. - Prior malignancy in the last 5 years, unless curatively treated and recurrence free (few exceptions apply).

No locations available

Arms	Assigned Interventions
Experimental: 1/OLAPARIB olaparib 300mg oral tablets; twice daily	Drug: OLAPARIB 300 mg olaparib tablets taken orally twice daily. All patients should continue to receive study treatment until objective radiological disease progression as per RECIST 1.1 as assessed by the investigator or the patient experiences unacceptable toxicity or they meet any other discontinuation criteria.
Active Comparator: 2/CHEMOTHERAPY Physician's choice single agent chemotherapy	Drug: Single agent chemotherapy Treatment of relapsed disease with single agent chemotherapy based on physician’s choice of weekly paclitaxel, topotecan, pegylated liposomal doxorubicin, or gemcitabine. All patients should continue to receive study treatment until objective radiological disease progression as per RECIST 1.1 as assessed by the investigator or the patient experiences unacceptable toxicity or they meet any other discontinuation criteria

Arms

Assigned Interventions

Experimental: 1/OLAPARIB
olaparib 300mg oral tablets; twice daily

Drug: OLAPARIB
300 mg olaparib tablets taken orally twice daily. All patients should continue to receive study treatment until objective radiological disease progression as per RECIST 1.1 as assessed by the investigator or the patient experiences unacceptable toxicity or they meet any other discontinuation criteria.

Active Comparator: 2/CHEMOTHERAPY
Physician's choice single agent chemotherapy

Drug: Single agent chemotherapy
Treatment of relapsed disease with single agent chemotherapy based on physician’s choice of weekly paclitaxel, topotecan, pegylated liposomal doxorubicin, or gemcitabine. All patients should continue to receive study treatment until objective radiological disease progression as per RECIST 1.1 as assessed by the investigator or the patient experiences unacceptable toxicity or they meet any other discontinuation criteria

Documents available

AstraZeneca Cancer Study Locator Service Phone 677 400 4656 Email [email protected]
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CSR Synopsis addendum
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Contact Backup

Elizabeth Lowe

[email protected]

Investigators

Principal Investigator

Richard T Penson

Harvard Medical School