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PI3K Inhibitor

Alpelisib + Olaparib for Ovarian Cancer

Phase 3

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant has histologically confirmed diagnosis of high-grade serous or high-grade endometrioid ovarian cancer, fallopian tube cancer, or primary peritoneal cancer

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline up to approximately 44 months

Awards & highlights

Study Summary

This trial is testing a new cancer treatment combination to see if it is more effective and has fewer side effects than current chemotherapy options for women with ovarian cancer who have not responded to other treatments.

Who is the study for?

This trial is for patients with high-grade serous ovarian cancer resistant to platinum therapy, without a BRCA mutation. They must have had 1-3 prior treatments and not be candidates for further platinum-based therapy. Participants need measurable disease or assessable CA-125 levels, good organ function, and an ECOG status of 0 or 1.Check my eligibility

What is being tested?

The study tests the effectiveness and safety of combining alpelisib with olaparib versus standard single-agent chemotherapy in treating high-grade serous ovarian cancer that's unresponsive to platinum treatment.See study design

What are the potential side effects?

Potential side effects include nausea, fatigue, blood count changes, increased sugar levels (due to alpelisib), anemia, digestive issues from olaparib; plus common chemo-related side effects like hair loss and nerve damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a specific type of ovarian, fallopian tube, or peritoneal cancer.

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I've had 1-3 treatments before and now need chemotherapy alone.

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I do not have a BRCA1 or BRCA2 gene mutation.

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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline up to approximately 44 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline up to approximately 44 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to approximately 44 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression Free Survival (PFS) based on Blinded Independent Review Committee (BIRC) assessment using RECIST 1.1 criteria

Secondary outcome measures

Area under the curve calculated to the end of a dosing interval (tau) at steady-state (AUCtau) of alpelisib and olaparib

Area under the curve from time zero to the last measurable concentration sampling time (AUClast)of alpelisib and olaparib

Change from baseline in Function Assessment of Cancer Therapy-Ovarian Trial Outcome Index (FACT-O TOI)

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Alpelisib+olaparibExperimental Treatment2 Interventions

Alpelisib 200 mg orally once daily and olaparib 200 mg orally twice daily on a continuous dosing schedule.

Group II: Paclitaxel or PLDActive Control2 Interventions

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 (physician discretion) intravenously every 28 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Alpelisib

2018

Completed Phase 3

~900

Olaparib

2007

Completed Phase 4

~2140

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,855 Previous Clinical Trials

4,196,996 Total Patients Enrolled

9 Trials studying Ovarian Cancer

2,252 Patients Enrolled for Ovarian Cancer

Media Library

Alpelisib (PI3K Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04729387 — Phase 3

Ovarian Cancer Research Study Groups: Alpelisib+olaparib, Paclitaxel or PLD

Ovarian Cancer Clinical Trial 2023: Alpelisib Highlights & Side Effects. Trial Name: NCT04729387 — Phase 3

Alpelisib (PI3K Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04729387 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial taking place across North America?

"23 cancer centres across the United States are currently signed up for this trial, these include but are not limited to US Oncology P A in Tyler and Arizona Oncology Associates SC in Phoenix."

Answered by AI

Are there any other similar trials to this one?

"Alpelisib has been researched since 1997. The first clinical trial took place in 1997 and was sponsored by Alfacell. Following the first study in 1997, which involved 300 patients, Alpelisib received its Phase 3 drug approval. Today there are 1380 active studies for Alpelisib across 3448 cities and 81 countries."

Answered by AI

What is the Alpelisib approval status by the FDA?

"Alpelisib has undergone multiple rounds of clinical testing, so it is estimated to be a safe medication with a score of 3."

Answered by AI

What medical condition is Alpelisib most effective in treating?

"Alpelisib has shown to be effective in treating patients with advanced soft tissue sarcoma (sts), advanced cervical cancer, and carcinoma."

Answered by AI

What other research studies have included Alpelisib?

"At this moment, 1380 studies are underway that involve Alpelisib. 346 of these trials are in the third and final stage. Most of the research surrounding Alpelisib is conducted in Shanghai, but there are a total 67067 locations running clinical trials for this medication."

Answered by AI

Can new patients still join this clinical trial?

"That is correct. The clinicaltrials.gov website has the latest information on this research project, which was originally posted on 7/2/2021 and was most recently updated on 5/23/2022. They are searching for 358 individuals to take part in this study at 23 different locations."

Answered by AI

How many people are being asked to participate in this clinical trial?

"In order to adequately power this study, the sponsor needs to recruit 358 eligible patients from multiple locations. Two such sites are US Oncology P A in Tyler, Texas and Arizona Oncology Associates SC in Phoenix, Arizona."

Answered by AI

Recent research and studies

Future OncologyJournal

EPIK-O/ENGOT-OV61: Alpelisib Plus Olaparib Vs Cytotoxic Chemotherapy in High-grade Serous Ovarian Cancer (phase III Study)

Konstantinopoulos, Panagiotis A, Antonio Gonzalez-Martin, Felipe Melo Cruz, Michael Friedlander, Rosalind Glasspool, Domenica Lorusso, Christian Marth, et al.. 2022. “EPIK-O/ENGOT-OV61: Alpelisib Plus Olaparib Vs Cytotoxic Chemotherapy in High-grade Serous Ovarian Cancer (phase III Study)”. Future Oncology. Future Medicine Ltd. doi:10.2217/fon-2022-0666.

clinicaltrials.govStudy

Alpelisib Plus Olaparib in Platinum-resistant/Refractory, High-grade Serous Ovarian Cancer, With no Germline BRCA Mutation Detected

2021. "Alpelisib Plus Olaparib in Platinum-resistant/Refractory, High-grade Serous Ovarian Cancer, With no Germline BRCA Mutation Detected". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04729387.