Alpelisib for Ovarian Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Ovarian Cancer+4 More
Alpelisib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Ovarian Cancer

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 13 Secondary · Reporting Duration: From baseline up to approximately 44 months

Day 8
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
Maximum Concentration (Cmax) of alpelisib and olaparib
Time to reach maximum concentration (Tmax) of alpelisib and olaparib
Month 44
Change from baseline in Function Assessment of Cancer Therapy-Ovarian Trial Outcome Index (FACT-O TOI)
Month 23
Duration of response (DOR) with confirmed response based on BIRC assessment and according to RECIST 1.1
Month 44
Overall survival
Month 18
Dose intensity
Number of participants with dose interruptions and dose reductions
Month 23
Progression Free Survival (PFS) based on Blinded Independent Review Committee (BIRC) assessment using RECIST 1.1 criteria
Month 23
Time to response (TTR) based on BIRC assessment and according to RECIST 1.1
Month 18
Time to definitive deterioration of the Eastern Cooperative Oncology Group (ECOG) performance status (PS)
Month 23
Clinical benefit rate (CBR) with confirmed response based on BIRC assessment according to RECIST 1.1
Overall Response Rate (ORR) with confirmed response based on BIRC assessment according to RECIST 1.1 criteria

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Paclitaxel or PLD
1 of 2
Alpelisib+olaparib
1 of 2

Active Control

Experimental Treatment

358 Total Participants · 2 Treatment Groups

Primary Treatment: Alpelisib · No Placebo Group · Phase 3

Alpelisib+olaparibExperimental Group · 2 Interventions: Alpelisib, Olaparib · Intervention Types: Drug, Drug
Paclitaxel or PLDActiveComparator Group · 2 Interventions: Pegylated liposomal doxorubicin (PLD), Paclitaxel · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alpelisib
FDA approved
Olaparib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline up to approximately 44 months

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,698 Previous Clinical Trials
3,523,866 Total Patients Enrolled
9 Trials studying Ovarian Cancer
2,252 Patients Enrolled for Ovarian Cancer

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a carrier of a BRCA1/2 mutation.
You have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 1st, 2021

Last Reviewed: November 1st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.