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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
Must not have
Participants with liver impairment and Child Pugh score B or C
Participant is in a state of small or large bowel obstruction or has other impairment of gastrointestinal (GI) function or GI disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline up to approximately 44 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing whether a combination of two drugs, alpelisib and olaparib, is more effective than standard chemotherapy for women with a specific type of ovarian cancer that doesn't respond well to usual treatments. Alpelisib works by stopping cancer cells from growing, while olaparib makes it harder for them to repair themselves. Olaparib has shown effectiveness in treating ovarian cancer, particularly in patients with certain genetic backgrounds.
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.
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.
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 belowSelect...
I have been diagnosed with a specific type of ovarian, fallopian tube, or peritoneal cancer.
Select...
I've had 1-3 treatments before and now need chemotherapy alone.
Select...
I do not have a BRCA1 or BRCA2 gene mutation.
Select...
I am fully active or can carry out light work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My liver is not working well (Child Pugh B or C).
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I have a blockage or other serious problem in my intestines.
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I have been treated with drugs targeting PI3K, mTOR, or AKT.
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression Free Survival (PFS) based on Blinded Independent Review Committee (BIRC) assessment using RECIST 1.1 criteria
Secondary study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
~960
Olaparib
2007
Completed Phase 4
~2190
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for ovarian cancer, such as PI3K inhibitors and PARP inhibitors, work by targeting specific pathways crucial for cancer cell survival and proliferation. PI3K inhibitors like alpelisib disrupt the PI3K/AKT/mTOR pathway, reducing tumor growth and promoting cancer cell death.
PARP inhibitors like olaparib prevent the repair of DNA damage in cancer cells, leading to cell death, particularly in those with BRCA mutations. These targeted therapies are important for ovarian cancer patients as they can offer more effective and potentially less toxic treatment options compared to traditional chemotherapy, especially for those with specific genetic profiles.
Clinical Benefits of Olaparib in Mexican Ovarian Cancer Patients With Founder Mutation <i>BRCA1</i>-Del ex9-12.
Clinical Benefits of Olaparib in Mexican Ovarian Cancer Patients With Founder Mutation <i>BRCA1</i>-Del ex9-12.
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,899 Previous Clinical Trials
4,207,046 Total Patients Enrolled
10 Trials studying Ovarian Cancer
2,348 Patients Enrolled for Ovarian Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently using other treatments for cancer.I have been diagnosed with a specific type of ovarian, fallopian tube, or peritoneal cancer.My liver is not working well (Child Pugh B or C).My bone marrow and organs are functioning well.I have a blockage or other serious problem in my intestines.I have recovered from previous cancer treatment side effects, except for hair loss.I haven't had surgery in the last 2 weeks or still have major side effects from it.I had radiotherapy recently and still feel its side effects, except for hair loss.My cancer can be tracked using a specific blood test for CA-125.I've had 1-3 treatments before and now need chemotherapy alone.I have been treated with drugs targeting PI3K, mTOR, or AKT.You have at least one measurable lesion according to specific criteria.I do not have a BRCA1 or BRCA2 gene mutation.I am fully active or can carry out light work.My ovarian cancer worsened shortly after or during platinum-based treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Alpelisib+olaparib
- Group 2: Paclitaxel or PLD
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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