Study to assess the efficacy and safety of alpelisib in combination with olaparib in patients with high-grade serous ovarian cancer without hereditary BRCA mutation that did not respond to prior platinum-based chemotherapy or recurred within six months after such therapy.
- Conditions
- MedDRA version: 20.0Level: LLTClassification code 10033130Term: Ovarian cancer NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Platinum-resistant or refractory, high-grade serous ovarian cancer with no germline BRCA mutationTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-004682-40-DK
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 358
Participant has histologically confirmed diagnosis of high-grade serous or high-grade endometrioid ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
Measurable disease, i.e., at least one measurable lesion per RECIST 1.1 criteria (a lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation).
If no measurable disease is present, the disease should be assessable by Gynecologic Cancer Intergroup criteria (GCIC) for CA-125.
Participant has no germline BRCA1/2 mutation as determined by an FDA-approved assay.
Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Participant has platinum-resistant (progression within one to six months after completing platinum-based therapy) or platinum refractory disease (progression during treatment or within 4 weeks after the last dose), where platinum-based therapy is not an option, according to the GCIG 5th Ovarian Cancer Consensus Conference definitions (Wilson et al 2016). The platinum-based chemotherapy regimen does not necessarily need to be the last regimen the participant received prior to study entry.
Participant must have received at least one but no more than three prior systemic treatment regimens and for whom single-agent chemotherapy is appropriate as the next line of treatment.
Participant has adequate bone marrow and organ function.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 179
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 179
Participant has received prior treatment with any PI3K, mTOR or AKT
inhibitor. Participant is concurrently using other anti-cancer therapy.
Participant is in a state of small or large bowel obstruction or has other impairment of gastrointestinal (GI) function or GI disease.
Participant has had surgery within 14 days prior to starting study drug or has not recovered from major adverse effects.
Participant has not recovered from all toxicities related to prior anticancer therapies to baseline or NCI CTCAE Version 4.03 Grade =1.
Exception to this criterion: participants with any grade of alopecia are allowed to enter the study.
Participants with liver impairment and Child Pugh score B or C
Participant has received radiotherapy = 4 weeks or limited field radiation for palliation = 2 weeks prior to randomization, and who has not recovered to baseline, grade 1 or better from related adverse effects of such therapy (with the exception of alopecia).
Participant has a known hypersensitivity to any of the study drugs or excipients.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method