This study has been transitioned to CTIS with ID 2024-511142-39-00 check the CTIS register for the current data. To determine the efficacy of olaparib versus placebo on progression free survival (PFS).
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Progression Free Survival
Secondary outcome
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).
Background summary
Ovarian cancer is the fifth most common cause of death from cancer in women.
The incidence of ovarian cancer increases with age and is most prevalent in the
eighth decade of life. More than 70% of the patients are diagnosed with
advanced disease and less than 40% of women with ovarian cancer are cured. The
standard therapy for advanced ovarian cancer consists of radical debulking
surgery followed by post-operative platinum-based first-line chemotherapy.
Olaparib (AZD2281, KU-0059436) is a potent Polyadenosine 5*diphosphoribose
[poly (ADP ribose)] polymerisation (PARP) inhibitor (PARP-1, -2 and -3). PARP
enzymes are essential for repairing DNA. Olaparib can stop or block de PARP
activity. Ovarian cancers in patients with BRCA1/2 mutations, cannot accurately
repair the DNA damage, which may become lethal to cells as it accumulates. In
such tumour types, olaparib may offer a potentially efficacious and less toxic
cancer treatment compared with currently available chemotherapy regimens. This
Phase III study will investigate the efficacy of olaparib administered as
maintenance therapy in the first line setting for the treatment of newly
diagnosed high risk advanced BRCA mutation positive ovarian cancer.
Study objective
This study has been transitioned to CTIS with ID 2024-511142-39-00 check the CTIS register for the current data.
To determine the efficacy of olaparib versus placebo on progression free
survival (PFS).
Study design
Phase 3, randomised, double-blind, placebo controlled study
Randomisation 2:1 with:
Olaparib 300 mg twice daily
Placebo twice daily
Intervention
Treatment with Olaparib 300 mg or Placebo.
Study burden and risks
Patient will get a CT scan or MRI scan every 12 weeks (RECICT). assessments
will be done on a regular base, like physical examination, vital signs, blood
sampling, ECGs and questionnaires.
Pregnancy or breastfeeding is not allowed.
The risks associated with the use of olaparib are:
Anemia, neutropenea, lymphopenia, thrombocytopenie, heartburn, nausea,
dizziness, diarrhea, vomiting and fatigue.
Louis Pasteurlaan 5
Zoetermeer 2719 EE
NL
Louis Pasteurlaan 5
Zoetermeer 2719 EE
NL
Listed location countries
Age
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
• 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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2024-511142-39-00 |
| EudraCT | EUCTR2013-001551-13-NL |
| ClinicalTrials.gov | NCT01844986 |
| CCMO | NL44290.031.13 |