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Closed (no longer recruiting)Last updated: 31 January 2024

EPIK-O: This phase III study is evaluating how safe and effective a combined treatment of targeted therapy (alpelisib) and a different cancer drug (olaparib), compared to chemotherapy (paclitaxel or pegylated liposomal doxorubicin), is in people with platinum resistant or refractory high-grade serous ovarian cancer, with no germline BRCA mutation detectedA Phase III, Multi-center, Randomized (1:1), Open-label, Active-controlled, Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Olaparib as Compared to Single Agent Cytotoxic Chemotherapy, in Participants With no Germline BRCA Mutation Detected, Platinum-resistant or Refractory, High-grade Serous Ovarian Cancer

Clinical summary

Summary

Eligible participants will be randomly allocated to either the Experimental Arm or Active Comparator Arm. In the Experimental Arm, participants will receive Alpelisib + olaparib. Alpelisib will be administered at a dose of 200mg, orally, once daily. Olaparib will be administered at a dose of 200mg, orally, twice daily. In the Active Comparator Arm, participants will receive the investigator's choice of one of 2 single agent cytotoxic chemotherapies: Paclitaxel (80 mg/m2, intravenously, weekly) or Pegylated liposomal Doxorubicin (PLD) (40-50 mg/m2, intravenously, every 28 days).

Conditions

This trial is treating patients with ovarian cancer

Cancer

Female Reproductive System Cancers Gynaecological

Age

People18+

Phase

III

Trial Acronym

EPIK-O

More information

Trial Identifiers

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Trial sponsor

Novartis Pharmaceuticals

Scientific Title

A Phase III, Multi-center, Randomized (1:1), Open-label, Active-controlled, Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Olaparib as Compared to Single Agent Cytotoxic Chemotherapy, in Participants With no Germline BRCA Mutation Detected, Platinum-resistant or Refractory, High-grade Serous Ovarian Cancer

Eligibility

Inclusion

  • 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. 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

Exclusion

  • 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 side effects
  • Participant has not recovered from all toxicities 5 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 side effects of such therapy (with the exception of alopecia).
  • Participant has a known hypersensitivity to any of the study drugs or excipients

Other inclusion/exclusion criteria may apply

Inclusion

  • You are able to swallow medication by mouth.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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