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.

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. - SOLO1

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54500

Enrollment

Registered

2013-06-05

Start date

2013-12-12

Completion date

Unknown

Last updated

2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Interventions

Treatment with Olaparib 300 mg or Placebo.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: •Female patients with newly diagnosed, histologically confirmed, high risk advanced (FIGO stage III - IV) BRCA mutated high grade serous or high grade endometriod 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).

Exclusion criteria

Exclusion criteria: • 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 peformed before randomisation to the study. , • Patients who have previously been diagnosed and treated for earlier stage ovarian, fallopian tube or primary peritoneal cancer.

Design outcomes

Primary

Measure	Time frame
Progression Free Survival	—

Secondary

Measure	Time frame
1. Overall survival (OS), time to earliest progression by RECIST or Cancer Antigen-125 (CA-125), or death and time from randomisation to second progression (PFS2) 2. 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 ABR: 3.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 potential future BRCA mutation assays (gene sequencing and large rearrangement analysis) 4. Time from randomisation to first subsequent therapy or death (TFST), or time from randomisation to second subsequent therapy or death (TSST) or time from randomisation to study treatment discontinuation or death (TDT).	—

Measure

Time frame

1. Overall survival (OS), time to earliest progression by RECIST or Cancer Antigen-125 (CA-125), or death and time from randomisation to second progression (PFS2) 2. 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 ABR: 3.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 potential future BRCA mutation assays (gene sequencing and large rearrangement analysis) 4. Time from randomisation to first subsequent therapy or death (TFST), or time from randomisation to second subsequent therapy or death (TSST) or time from randomisation to study treatment discontinuation or death (TDT).

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)