Neoplasms

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Gland and Hormone Related Diseases

All Conditions

Immune System Diseases

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Hypersensitivity

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Olaparib

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

300mg Olaparib or placebo tablets taken orally twice daily until objective radiological disease progression as per RECIST as assessed by the investigator (or as long as in the investigator's opinion they are benefiting from treatment and they do not meet any other discontinuation criteria). Dose reduction to 250mg and subsequently 200mg is permitted following confirmation of toxicity.

Olaparib 300mg tablets

Placebo to match olaparib 300mg

Professor E Pujade-Lauraine, MD, PhD

A Phase III, randomised, double-blind, placebo-controlled, multi-centre study to assess the efficacy of olaparib maintenance monotherapy in relapsed high grade serous ovarian cancer (HGSOC) patients (including patients with primary peritoneal and / or fallopian tube cancer) or high grade endometrioid cancer with BRCA mutations (documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)) who have responded following platinum based chemotherapy.

Comparison of olaparib against a placebo in patients with ovarian cancer whose cancer has already improved by taking platinum based chemotherapy. The patients must also have a fault in their DNA which codes for the BRCA protein. The BRCA protein helps mend broken DNA in the cells of the body; if this protein doesn't work properly it can increase the chance of getting cancer. The aim of this study is to see whether patients taking olaparib tablets last longer until their cancer gets worse, compared to those taking the placebo tablet. The study is also looking to see if there is an overall improvement to how long the patients survive whilst taking olaparib tablets compared to the placebo tablets; and the quality of their life whilst living with ovarian cancer.

Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy

Phase III Randomised, Double Blind, Placebo Controlled Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed BRCA Mutated Ovarian Cancer Patients With a Complete or Partial Response Following Platinum Based Chemotherapy

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

To determine the efficacy by progression free survival (PFS) (using investigator assessment according to modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1)) of olaparib maintenance monotherapy compared to placebo in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy.

To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy by assessment of overall survival (OS).

To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy by assessment of time to earliest progression by RECIST or CA-125 or death.

To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated relapsed ovarian cancer patients who are in complete response or partial response following first line platinum based chemotherapy by assessment of time from randomization up to second progression

To compare the effects of olaparib maintenance monotherapy compared to placebo on Health-related Quality of Life (HRQoL) as assessed by the trial outcome index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O) in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy. The TOI ranges from 0-100 and a higher score indicates a higher HRQoL.

To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomization to first subsequent therapy or death (TFST).

To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomization to second subsequent therapy or death (TSST).

To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomization to study treatment discontinuation or death (TDT).

To assess 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).

To determine the exposure to olaparib in patients receiving olaparib maintenance monotherapy

European Network of Gynaecological Oncological Trial Groups (ENGOT)

Myriad Genetic Laboratories, Inc.

Merck Sharp & Dohme LLC

AstraZeneca

Olaparib 300 Tablets (Global Cohort)

Placebo Tablets (Global Cohort)

Olaparib 300 Tablets (China Cohort)

Placebo Tablets (China Cohort)

Olaparib 300mg Tablets

Placebo Tablets

Total

Global Cohort

China Cohort

There are 196 Olaparib patients in the Global Cohort and 22 in the China Cohort (Total = 218).

There are 99 Placebo patients in the Global Cohort and 10 in the China Cohort (Total = 109)

Age, Continuous

There are 196 Olaparib patients in the Global Cohort and 22 in the China Cohort (Total = 218). There are 99 Placebo patients in the Global Cohort and 10 in the China Cohort (Total = 109)

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race/Ethnicity, Customized

Global Cohort: 196 Olaparib, 99 Placebo China Cohort: 22 Olaparib, 10 Placebo

The outbreak of the COVID-19 pandemic shortly before the final OS DCO (03 February 2020) was not judged to meaningfully impact the overall quality of the study, including the conduct, data, and interpretation of results.

Global Clinical Program Lead

Olaparib 300mg Tablets (Global Cohort)

Olaparib 300mg Tablets (China Cohort)

Full Analysis Set (FAS) consisting of all patients randomized as part of global enrolment, excluding China \[Primary analysis\] China Full Analysis Set (FAS) includes all patients who were randomised at sites in China.

Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1)

Full Analysis Set (FAS) consisting of all patients randomized as part of global enrolment (excluding China) China Full Analysis Set (FAS) includes all patients who were randomised at sites in China.

Efficacy in Patients Following Platinum Based Chemotherapy by Assessment of Overall Survival

Full Analysis Set (FAS) consisting of all patients randomized as part of global enrolment (excluding China).

China Full Analysis Set (FAS) includes all patients who were randomised at sites in China.

Efficacy in Patients Following Platinum Based Chemotherapy by Assessment of Time to Earliest Progression by RECIST or Cancer Antigen (CA-125) or Death

Efficacy in Patients Following Platinum Based Chemotherapy by Assessment of Time From Randomization to Second Progression

Full Analysis Set (FAS) consisting of all patients randomized as part of global enrolment (excluding China) with a baseline and post baseline TOI score available \[This endpoint was not assessed in the China Cohort\]

Change From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O)

Efficacy of Olaparib by Time to First Subsequent Therapy or Death (TFST)

Olaparib 300mg Tablets (ChinaCohort)

Efficacy of Olaparib by Time to Second Subsequent Therapy or Death (TSST)

Efficacy of Olaparib by Time From Randomization to Study Treatment Discontinuation or Death (TDT)

Full Analysis Set (FAS) consisting of all patients randomized as part of global enrolment (excluding China) and confirmed as Myriad gBRCAm \[This endpoint was not assessed in the China Cohort\]

Efficacy in Patients With a Deleterious or Suspected Deleterious Variant in Either of the BRCA Genes by Assessment of PFS.

Day 1 - Pre-dose

Day 1 - 1 hour

Day 15 - Pre-dose

Day 15 - 1 hour

Day 29 - Pre-dose

Pharmacokinetic (PK) Analysis Set - all patients who receive study treatment as per protocol, do not violate or deviate from the protocol in ways that would significantly affect the PK analyses and have valid PK data.

The PK Analysis Set is a subset of the Global FAS; PK analysis was not performed in the China Cohort.

Spots Global Cancer Trial Database for placebo to match olaparib 300mg