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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01844986




Registration number
NCT01844986
Ethics application status
Date submitted
30/04/2013
Date registered
3/05/2013
Date last updated
29/05/2024

Titles & IDs
Public title
Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy.
Scientific title
A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Advanced (FIGO Stage III-IV) Ovarian Cancer Following First Line Platinum Based Chemotherapy.
Secondary ID [1] 0 0
2013-001551-13
Secondary ID [2] 0 0
D0818C00001
Universal Trial Number (UTN)
Trial acronym
SOLO-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Newly Diagnosed 0 0
Advanced Ovarian Cancer 0 0
FIGO Stage III-IV 0 0
BRCA Mutation 0 0
Complete Response 0 0
Partial Response 0 0
First Line Platinum Chemotherapy 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Olaparib 300mg tablets

Experimental: Olaparib tablets p.o. 300mg twice daily - Olaparib/placebo tablets p.o 300mg twice daily for up to 3 years or until objective radiological disease progression as per RECIST as assessed by the Investigator. Patients with evidence of stable disease (or those who have progressed), may continue on treatment beyond 2 years, if in the patient's best interest. Dose reduction to 250mg and subsequently 200mg is permitted following confirmation of toxicity

Placebo Comparator: Placebo tablets p.o. twice daily - Olaparib/placebo tablets p.o 300mg twice daily for up to 3 years or until objective radiological disease progression as per RECIST as assessed by the Investigator. Patients with evidence of stable disease (or those who have progressed), may continue on treatment beyond 2 years, if in the patient's best interest. Dose reduction to 250mg and subsequently 200mg is permitted following confirmation of toxicity


Treatment: Drugs: Olaparib 300mg tablets
Olaparib/placebo tablets p.o 300mg twice daily for up to 2 years or until objective radiological disease progression as per RECIST as assessed by the Investigator. Patients with evidence of stable disease (or those who have progressed), may continue on treatment beyond 2 years, if in the patient's best interest. Dose reduction to 250mg and subsequently 200mg is permitted following confirmation of toxicity.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1)
Timepoint [1] 0 0
Radiologic scans performed at baseline then every 12 weeks up to 156 weeks, then every 24 weeks thereafter until objective radiological disease progression. DCO: 17 May 2018
Secondary outcome [1] 0 0
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Overall Survival
Timepoint [1] 0 0
Assessed every 4 weeks until treatment discontinues (up to a max of 156 weeks), then as per protocol. Analysis performed with DCO: 17May2018. Further analyses will be performed at 7 years (descriptive), after 206 events and after 60% maturity.
Secondary outcome [2] 0 0
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time to Earliest Progression by RECIST or Cancer Antigen (CA-125) or Death
Timepoint [2] 0 0
CA-125 performed at baseline + every 4 weeks. Radiologic scans performed at baseline + every 12 weeks up to 156 weeks, then every 24 weeks until objective radiological disease progression. DCO:17May2018
Secondary outcome [3] 0 0
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time From Randomization to Second Progression
Timepoint [3] 0 0
Following first progression disease then assessed per local practice every 12 weeks until second progression.
Secondary outcome [4] 0 0
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)
Timepoint [4] 0 0
Questionnaires will be given to the patient at baseline, at Day 29 and then every 12 weeks for 156 weeks, then every 24 weeks or until the data cut off for the PFS analysis, change in TOI over 24 months reported
Secondary outcome [5] 0 0
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time to First Subsequent Therapy or Death (TFST)
Timepoint [5] 0 0
Assessed every 12 weeks following treatment discontinuation. Analysis performed with DCO: 17May2018. Further analyses will be performed at 7 years (descriptive), after 206 events and after 60% maturity.
Secondary outcome [6] 0 0
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time to Second Subsequent Therapy or Death (TSST)
Timepoint [6] 0 0
Assessed every 12 weeks following treatment discontinuation. Analysis performed with DCO: 17May2018. Further analyses will be performed at 7 years (descriptive), after 206 events and after 60% maturity.
Secondary outcome [7] 0 0
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time From Randomization to Study Treatment Discontinuation or Death (TDT)
Timepoint [7] 0 0
Time elapsed from randomization to study treatment discontinuation or death. Analysis performed with DCO: 17May2018. Further analyses will be performed at 7 years (descriptive), after 206 events and after 60% maturity.
Secondary outcome [8] 0 0
Efficacy in Patients With a Deleterious or Suspected Deleterious Variant in Either of the BRCA Genes by Assessment of PFS
Timepoint [8] 0 0
Radiologic scans performed at baseline then every 12 weeks for the first 156 weeks, then every 24 weeks thereafter, assessed until disease progression. Analysis of data assessed up to a maximum of 54 months.

Eligibility
Key inclusion criteria
- Female patients with newly diagnosed, histologically confirmed, high risk advanced
(FIGO stage III - IV) BRCA mutated high grade serous or high grade endometrioid
ovarian cancer, primary peritoneal cancer and / or fallopian - tube cancer who have
completed first line platinum based chemotherapy (intravenous or intraperitoneal).

- Stage III patients must have had one attempt at optimal debulking surgery (upfront or
interval debulking). Stage IV patients must have had either a biopsy and/or upfront or
interval debulking surgery.

- 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).

- Patients who have completed first line platinum (e.g. carboplatin or cisplatin),
containing therapy (intravenous or intraperitoneal) prior to randomisation:

- Patients must have, in the opinion of the investigator, clinical complete response or
partial response and have no clinical evidence of disease progression on the post
treatment scan or rising CA-125 level, following completion of this chemotherapy
course. Patients with stable disease on the post-treatment scan at completion of first
line platinum-containing therapy are not eligible for the study.

- Patients must be randomized within 8 weeks of their last dose of chemotherapy
Minimum age
18 Years
Maximum age
130 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- BRCA1 and/or BRCA2 mutations that are considered to be non detrimental (e.g. "Variants
of uncertain clinical significance" or "Variant of unknown significance" or "Variant,
favor polymorphism" or "benign polymorphism" etc).

- Patients with early stage disease (FIGO Stage I, IIA, IIB or IIC)

- Stable disease or progressive disease on the post-treatment scan or clinical evidence
of progression at the end of the patient's first line chemotherapy treatment.

- Patients where more than one debulking surgery has been performed before randomisation
to the study. (Patients who, at the time of diagnosis, are deemed to be unresectable
and undergo only a biopsy or oophorectomy but then go on to receive chemotherapy and
interval debulking surgery are eligible).

- Patients who have previously been diagnosed and treated for earlier stage ovarian,
fallopian tube or primary peritoneal cancer.

- Patients who have previously received chemotherapy for any abdominal or pelvic tumour,
including treatment for prior diagnosis at an earlier stage for their ovarian,
fallopian tube or primary peritoneal cancer. (Patients who have received prior
adjuvant chemotherapy for localised breast cancer may be eligible, provided that it
was completed more than three years prior to registration, and that the patient
remains free of recurrent or metastatic disease).

- Patients with synchronous primary endometrial cancer unless both of the following
criteria are met: 1) stage <2 2) less than 60 years old at the time of diagnosis of
endometrial cancer with stage IA or IB grade 1 or 2, or stage IA grade 3 endometrioid
adenocarcinoma OR = 60 years old at the time of diagnosis of endometrial cancer with
Stage IA grade 1 or 2 endometrioid adenocarcinoma. Patients with serous or clear cell
adenocarcinoma or carcinosarcoma of the endometrium are not eligible.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/08/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/08/2028
Actual
Sample size
Target
Accrual to date
Final
450
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Mercy Hospital for Women - Heidelberg
Recruitment hospital [2] 0 0
The Royal Womens Hospital - Parkville
Recruitment hospital [3] 0 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 0 0
- Heidelberg
Recruitment postcode(s) [2] 0 0
- Parkville
Recruitment postcode(s) [3] 0 0
- Randwick
Recruitment outside Australia
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Alabama
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Alaska
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Córdoba
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Hospitalet deLlobregat(Barcelo
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Madrid
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Valencia
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Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
GOG Foundation
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Myriad Genetic Laboratories, Inc.
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/Industry
Name [3] 0 0
Merck Sharp & Dohme LLC
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Olaparib Monotherapy in Patients with BRCA Mutated Ovarian Cancer following First Line
Platinum Based Chemotherapy.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01844986
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Prof Paul DiSilvestro, MD
Address 0 0
Women & Infants Hospital, Providence, Rhode Island, USA
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
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Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries