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Trial record 1 of 1 for:    SOLO3
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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)

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by AstraZeneca
Sponsor:
Collaborator:
Myriad Genetic Laboratories, Inc.
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT02282020
First received: October 20, 2014
Last updated: June 8, 2017
Last verified: June 2017
October 20, 2014
June 8, 2017
February 6, 2015
December 22, 2017   (Final data collection date for primary outcome measure)
Progression Free Survival (PFS) by blinded independent central review using Response Evaluation Criteria In Solid Tumours (RECIST) data [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months ]
To determine the efficacy of olaparib vs. physician's choice single agent chemotherapy by assessment of PFS using blinded independent central review
Same as current
Complete list of historical versions of study NCT02282020 on ClinicalTrials.gov Archive Site
  • Efficacy of olaparib vs. physician's choice single agent chemotherapy by assessment of Overall Survival (OS) [ Time Frame: Up to 60 months ]
    To determine the efficacy of olaparib vs. Physician's choice single agent chemotherapy by assessment of OS
  • Efficacy in patients following platinum based chemotherapy by assessment of time from randomisation to second progression [ Time Frame: From date of randomization until the date of second documented progression or date of death from any cause, whichever came first, assessed up to 60 months ]
    To determine the efficacy of olaparib vs. Physician's choice single agent chemotherapy by assessment of time from randomisation up to second progression
  • Efficacy in patients following platinum based chemotherapy by assessment of time to earliest progression by Cancer Antigen (CA-125) or death [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months ]
    To determine the efficacy of olaparib vs. Physician's choice single agent chemotherapy by assessment of time to earliest progression by CA-125 or death.
  • Time to deterioration of Health-Related Quality of Life (HRQoL) as assessed by trial outcome index (TOI) and the Functional Assessment of Cancer Therapy - Ovarian (FACT-O) [ Time Frame: Up to 48 weeks ]
    To determine the effects of olaparib vs. Physician's choice single agent chemotherapy by assessment of HRQoL as measured by TOI and FACT-O
  • Efficacy in patients with a deleterious or suspected deleterious variant in either of the BRCA genes by assessment of PFS. [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months ]
    To determine efficacy of olaparib in patients identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (gene sequencing and large rearrangement analysis).
  • Efficacy of olaparib by time to first subsequent therapy or death (TFST). [ Time Frame: From date of randomization until the date of first subsequent therapy or death assessed up to 60 months ]
    To determine the efficacy of olaparib vs. Physician's choice single agent chemotherapy by assessment of time from randomisation to first subsequent therapy or death (TFST).
  • Efficacy of olaparib by time to second subsequent therapy or death (TSST). [ Time Frame: From date of randomization until the date of second subsequent therapy or death assessed up to 60 months ]
    To determine the efficacy of olaparib vs. Physician's choice single agent chemotherapy by assessment of time from randomisation to second subsequent therapy or death (TSST).
  • Efficacy of olaparib by time from randomisation to study treatment discontinuation or death (TDT). [ Time Frame: From date of randomization until the date of study treatment discontinuation or death assessed up to 60 months ]
    To determine the efficacy of olaparib vs. Physician's choice single agent chemotherapy by assessment of time from randomisation to study treatment discontinuation or death (TDT).
  • Safety and tolerability of olaparib by assessment of the number of Adverse Events (AEs). [ Time Frame: Up to 30 days post-treatment for up to 60 months ]
    To assess the safety and tolerability of olaparib maintenance monotherapy
  • Safety and tolerability of olaparib by review of laboratory parameters, ECG and vital signs [ Time Frame: Until study treatment discontinuation up to 60 months ]
    To assess the safety and tolerability of olaparib maintenance monotherapy
  • Efficacy in patients following platinum based chemotherapy by assessment of time to earliest progression by RECIST or death [ Time Frame: Radiological assessments will be scheduled every 8 weeks (+/- 1 week) from randomisation for 48 weeks and every 12 weeks (+/- 1 week) thereafter until objective disease progression. ]
    To determine the efficacy of olaparib vs. Physician's choice single agent chemotherapy by assessment of time to earliest progression by RECIST or death.
Same as current
Not Provided
Not Provided
 
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.
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.
Comparison of olaparib vs. physician's choice of single agent standard of care non-platinum based chemotherapy in patients with germline Breast Cancer susceptibility gene (gBRCA) mutated ovarian cancer who have progressed at least 6 months after the last platinum based chemotherapy. Patient should have received at least 2 prior lines of platinum based chemotherapy. The aim of the study is to assess the efficacy and safety of olaparib tablets.
This open label, randomised, controlled, multi-centre study will assess the efficacy and safety of single agent olaparib vs. standard of care, based on physician's choice of single agent chemotherapy ( i.e paclitaxel, or topotecan, or pegylated liposomal doxorubicin, or gemcitabine) in platinum sensitive or partially platinum sensitive relapsed ovarian cancer patients who carry germline deleterious or suspected deleterious BRCA mutation and who have received at least 2 prior lines of platinum based chemotherapy. 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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Relapsed Ovarian Cancer, BRCA Mutation, Platinum Sensitivity
  • 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.
  • 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
  • Experimental: 1/OLAPARIB
    olaparib 300mg oral tablets; twice daily
    Intervention: Drug: OLAPARIB
  • Active Comparator: 2/CHEMOTHERAPY
    Physician's choice single agent chemotherapy
    Intervention: Drug: Single agent chemotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
411
December 23, 2019
December 22, 2017   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: Female
18 Years to 130 Years   (Adult, Senior)
No
Contact: AstraZeneca Clinical Study Information Center, Senior Medical Lead 1-877-240-9479 information.center@astrazeneca.com
Contact: Elizabeth S Lowe, Dr Elizabeth.Lowe@astrazeneca.com
Argentina,   Belgium,   Brazil,   Canada,   Czechia,   Hungary,   Israel,   Italy,   Korea, Republic of,   Mexico,   Poland,   Spain,   United Kingdom,   United States
Czech Republic
 
NCT02282020
D0816C00010
Yes
Not Provided
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Myriad Genetic Laboratories, Inc.
Principal Investigator: Richard T Penson, Associate Prof. of Medicine Harvard Medical School
AstraZeneca
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP