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Ovarian cancer drug combo trial halted early

NCT ID NCT04729387

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tested a combination of two targeted drugs, alpelisib and olaparib, against standard chemotherapy in 358 women with a tough-to-treat type of ovarian cancer that had stopped responding to platinum-based chemotherapy. The study only included women without a BRCA gene mutation. Unfortunately, the trial was terminated early, so we don't have full results on whether the combination worked better than chemo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
alpelisib and olaparib combination
What this could lead to
If successful, this could offer a new targeted therapy option for women with platinum-resistant ovarian cancer who do not have a BRCA mutation.
What could go wrong
The trial was terminated early, so results are limited. The combination may not prove better than standard chemotherapy, and side effects from the drugs could be significant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

358 people

The number who actually took part.

Started

Jul 2021

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * 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 received prior bevacizumab or is not eligible to receive bevacizumab due to medical reasons. Key Exclusion Criteria: * 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 * Participant has an established diagnosis of diabetes mellitus type I or uncontrolled type II based on fasting plasma glucose and HbA1c * 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 * Participant has a history of myelodysplastic syndrome or acute myeloid leukemia, or presents clinical and/ or laboratory features suggestive thereof. Other inclusion/exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

fallopian tube cancer ovarian cancer ovarian endometrioid adenocarcinoma ovarian serous adenocarcinoma primary peritoneal carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ovarian cancer

Contacts and locations

Locations

  • Arizona Oncology Associates

    Phoenix, Arizona, 85016, United States

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57106, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115, United States

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901, United States

  • Florida Cancer Specialists

    West Palm Beach, Florida, 33401, United States

  • HonorHealth

    Phoenix, Arizona, 85016, United States

  • Maryland Oncology Hematology P A

    Silver Spring, Maryland, 20904, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Memorial Sloan Kettering Cancer Ctr

    New York, New York, 10065, United States

  • Novartis Investigative Site

    CABA, Buenos Aires, C1125ABD, Argentina

  • Novartis Investigative Site

    Buenos Aires, C1012AAR, Argentina

  • Novartis Investigative Site

    Caba, C1015ABO, Argentina

  • Novartis Investigative Site

    Bedford Park, South Australia, 5041, Australia

  • Novartis Investigative Site

    Shepparton, Victoria, 3630, Australia

  • Novartis Investigative Site

    Sydney, 2031, Australia

  • Novartis Investigative Site

    Innsbruck, Tyrol, 6020, Austria

  • Novartis Investigative Site

    Graz, 8036, Austria

  • Novartis Investigative Site

    Brussels, 1000, Belgium

  • Novartis Investigative Site

    Leuven, 3000, Belgium

  • Novartis Investigative Site

    Namur, 5000, Belgium

  • Novartis Investigative Site

    Belo Horizonte, Minas Gerais, 30130-100, Brazil

  • Novartis Investigative Site

    São Paulo, São Paulo, 04014-002, Brazil

  • Novartis Investigative Site

    Calgary, Alberta, T2N 5G2, Canada

  • Novartis Investigative Site

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Novartis Investigative Site

    London, Ontario, N6A 5W9, Canada

  • Novartis Investigative Site

    Toronto, Ontario, M4N 3M5, Canada

  • Novartis Investigative Site

    Chengdu, Sichuan, 610041, China

  • Novartis Investigative Site

    Beijing, 100036, China

  • Novartis Investigative Site

    Jinan, 250012, China

  • Novartis Investigative Site

    Shanghai, 200032, China

  • Novartis Investigative Site

    Tianjin, 300480, China

  • Novartis Investigative Site

    Ostrava, Poruba, 708 52, Czechia

  • Novartis Investigative Site

    Nový Jičín, 741 01, Czechia

  • Novartis Investigative Site

    Prague, 128 08, Czechia

  • Novartis Investigative Site

    Herlev, DK-2730, Denmark

  • Novartis Investigative Site

    Odense C, 5000, Denmark

  • Novartis Investigative Site

    Kuopio, FIN-70211, Finland

  • Novartis Investigative Site

    Tampere, FIN-33521, Finland

  • Novartis Investigative Site

    Turku, FIN 20521, Finland

  • Novartis Investigative Site

    Besançon, 25030, France

  • Novartis Investigative Site

    Lyon, 69373, France

  • Novartis Investigative Site

    Paris, 75012, France

  • Novartis Investigative Site

    Pierre-Bénite, 69495, France

  • Novartis Investigative Site

    Villejuif, 94800, France

  • Novartis Investigative Site

    Mannheim, Baden-Wurttemberg, 68305, Germany

  • Novartis Investigative Site

    Dresden, Saxony, 01307, Germany

  • Novartis Investigative Site

    Berlin, 13353, Germany

  • Novartis Investigative Site

    Essen, 45136, Germany

  • Novartis Investigative Site

    Bologna, BO, 40138, Italy

  • Novartis Investigative Site

    Florence, FI, 50134, Italy

  • Novartis Investigative Site

    Milan, MI, 20133, Italy

  • Novartis Investigative Site

    Roma, RM, 00168, Italy

  • Novartis Investigative Site

    Vicenza, VI, 36100, Italy

  • Novartis Investigative Site

    Milan, 20141, Italy

  • Novartis Investigative Site

    Naples, 80131, Italy

  • Novartis Investigative Site

    Kuala Lumpur, Kuala Lumpur, 50586, Malaysia

  • Novartis Investigative Site

    Kota Kinabalu, Sabah, 88996, Malaysia

  • Novartis Investigative Site

    Kuching, Sarawak, 93586, Malaysia

  • Novartis Investigative Site

    Kuala Lumpur, 59100, Malaysia

  • Novartis Investigative Site

    Monterrey, Nuevo León, 64460, Mexico

  • Novartis Investigative Site

    Mexico City, 04700, Mexico

  • Novartis Investigative Site

    Eindhoven, 5623 EJ, Netherlands

  • Novartis Investigative Site

    Loures, 2674-514, Portugal

  • Novartis Investigative Site

    Porto, 4200-072, Portugal

  • Novartis Investigative Site

    Arkhangelsk, 163045, Russia

  • Novartis Investigative Site

    Singapore, 119074, Singapore

  • Novartis Investigative Site

    Singapore, 168583, Singapore

  • Novartis Investigative Site

    Bratislava, 83310, Slovakia

  • Novartis Investigative Site

    Seoul, 03080, South Korea

  • Novartis Investigative Site

    Seoul, 03722, South Korea

  • Novartis Investigative Site

    Pamplona, Navarre, 31008, Spain

  • Novartis Investigative Site

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    Barcelona, 08036, Spain

  • Novartis Investigative Site

    Córdoba, 14004, Spain

  • Novartis Investigative Site

    Madrid, 28034, Spain

  • Novartis Investigative Site

    Valencia, 46010, Spain

  • Novartis Investigative Site

    Taichung, 407219, Taiwan

  • Novartis Investigative Site

    Taipei, 10002, Taiwan

  • Novartis Investigative Site

    Taipei, 11217, Taiwan

  • Novartis Investigative Site

    Izmir, Karsiyaka, 35575, Turkey (Türkiye)

  • Novartis Investigative Site

    Ankara, Sihhiye-Altindag, 06230, Turkey (Türkiye)

  • Novartis Investigative Site

    Adana, Yuregir, 01230, Turkey (Türkiye)

  • Novartis Investigative Site

    Ankara, 06520, Turkey (Türkiye)

  • Novartis Investigative Site

    Glasgow, G12 0YN, United Kingdom

  • Novartis Investigative Site

    London, SE1 9RT, United Kingdom

  • Novartis Investigative Site

    Manchester, M20 2BX, United Kingdom

  • Oncology Hematology Care Inc

    Cincinnati, Ohio, 45242, United States

  • Tennessee Oncology

    Nashville, Tennessee, 37203, United States

  • Texas Oncology

    Amarillo, Texas, 79124, United States

  • Texas Oncology Northeast Texas

    Tyler, Texas, 75702, United States

  • Texas Oncology P A

    Bedford, Texas, 76022, United States

  • Texas Oncology P A

    San Antonio, Texas, 78217, United States

  • University Of Cincinnati

    Cincinnati, Ohio, 45267, United States

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