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New drug cocktail shows promise in early ovarian cancer trial

NCT ID NCT05276973

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 This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 02, 2026 · Updated 3 times

Summary

This early-phase trial is testing whether adding the targeted drug ipatasertib to standard chemotherapy (paclitaxel and carboplatin) is safe and effective for women with advanced ovarian cancer. The study involves 25 participants with stage III or IV disease. The goal is to find the best dose and see if the combination can better control tumor growth.

What this could mean

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

Active substance
Ipatasertib (a targeted drug) plus paclitaxel and carboplatin (chemotherapy)
What this could lead to
If it works, this could lead to a more effective initial treatment for advanced ovarian cancer, potentially delaying tumor growth.
What could go wrong
This is a very early (Phase I) trial with only 25 participants, so it's mainly checking safety and dosing. The drug combination may not work better than standard chemo, and side effects 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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

25 people

The number who actually took part.

Started

Sep 2022

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

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

Ages

18 years and older

Sex

Female participants only

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.

Inclusion Criteria: * Pathologically proven diagnosis of ovarian cancer (ovarian cancer = fallopian tube cancer, ovarian cancer, primary peritoneal cancer). Required data element: submission of pathology report. Patients with the following histologic cell types are eligible: * High grade serous * Endometrioid adenocarcinoma, grade 3 Genomic/genetic testing results will be a data collection element if performed as part of usual care (germline genetic testing, tumor genomic testing, homologous recombination deficiency \[HRD\] testing). Genetic/genomic testing results should be uploaded if they become available anytime during conduct of the study * Appropriate stage for study entry defined as stage III or stage IV based on the following diagnostic workup: * History/physical examination within 14 days prior to registration * Imaging with computed tomography (CT) chest/abdomen/pelvis (C/A/P) within 28 days prior to registration * Patients must have evaluable disease or measurable disease defined by RECIST version (v) 1.1. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be \>= 10 mm when measured by CT or magnetic resonance imaging (MRI). Lymph nodes must be \>= 15 mm in short axis when measured by CT or MRI * Pre-treatment formalin-fixed, paraffin-embedded (FFPE) tumor block collected from laparoscopy (preferred) or five 18G cores by radiology/interventional radiology (acceptable) must be available for submission * Disease must be considered unresectable via primary debulking surgery and in need of neoadjuvant chemotherapy (NACT) prior to debulking surgery. This assessment of unresectability can be made via imaging or laparoscopic scoring * No prior therapy directed at ovarian cancer * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 within 14 days prior to registration * Absolute neutrophil count \>= 1,000/mcl (within 14 days prior to registration) * Platelets \>= 100,000/mcl (within 14 days prior to registration) * Creatinine =\< institutional/laboratory upper limit of normal (ULN) or creatinine clearance (CrCL) or estimated glomerular filtration rate (eGFR) of \>= 60 mL/min estimated using either the Cockcroft-Gault equation, the Modification of Diet in Renal Disease Study, or as reported in the comprehensive metabolic panel/basic metabolic panel (eGFR) (within 14 days prior to registration) * Total bilirubin =\< 1.5 x ULN (patients with known Gilbert's disease who have bilirubin level =\< 3 x ULN may be enrolled) (within 14 days prior to registration) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =\< 3 x ULN (within 14 days prior to registration) * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better * Women of childbearing potential (WOCBP) must agree to use two forms of birth control (hormonal or barrier method of birth control; abstinence) agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of \< 1% per year during the treatment period and for at least 28 days after the last dose of ipatasertib and agreement to refrain from donating eggs during this same period * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load * The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information * Ability to understand and willingness to sign an institutional review board (IRB) approved written informed consent document (or that of legally authorized representative, if applicable) Exclusion Criteria: * Prior treatment with agent(s) targeting PI3K/AKT/mTor pathway * History of allergic reactions attributed to compounds of similar chemical or biologic composition to ipatasertib, paclitaxel or carboplatin * Currently receiving any other investigational agents or has received an investigational agent within 4 weeks of study registration * Abnormal gastrointestinal function. This includes gastrointestinal (GI) obstruction or bleeding or signs/symptoms thereof within 3 months of study registration * Patients with a history of abdominal fistula will be considered eligible if the fistula was surgically repaired or has healed, there has been no evidence of fistula for at least 6 months, and patient is deemed to be at low risk of recurrent fistula * Received prior radiotherapy to any portion of the abdominal cavity or pelvis * Patients with uncontrolled intercurrent illness * Patients with psychiatric illness/social situations that would limit compliance with study requirements * Patients with active infections requiring intravenous antibiotics * Patients with diabetes either requiring insulin therapy or with a baseline fasting glucose \>= 160 mg/dL and/or high glycosylated hemoglobin (HbA1c) (\> 8), suggesting poorly controlled diabetes. Fasting is defined as abstaining from food and drink (with the exception of water) for at least 8 hours * Patients with grade \>= 2 uncontrolled or untreated hypercholesterolemia (\> 300 mg/dL) or hypertriglyceridemia (\> 300 mg/dL) would be an ineligible * History of or active inflammatory bowel disease (e.g., Crohn's disease and/or ulcerative colitis) or active bowel inflammation (e.g., diverticulitis) * Lung disease: Pneumonitis, interstitial lung disease, idiopathic pulmonary fibrosis, cystic fibrosis, Aspergillosis, active tuberculosis, or history of opportunistic infections (pneumocystis pneumonia or cytomegalovirus pneumonia) * Patients with known brain metastases or leptomeningeal disease are not eligible, as prior treatment directed at ovarian cancer is not allowed * Treatment with strong CYP3A inhibitors or strong CYP3A inducers within 2 weeks or 5 drug-elimination half-lives, whichever is longer, prior to registration * Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product * Known clinically significant history of liver disease consistent with Child Pugh class B or C, including active viral or other hepatitis, current drug or alcohol abuse, or cirrhosis * Pregnant women are excluded from this study because ipatasertib is an oral AKT inhibitor with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ipatasertib, breastfeeding should be discontinued if the mother is treated with ipatasertib. These potential risks may also apply to other agents used in this study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Augusta University Medical Center

    Augusta, Georgia, 30912, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • UCSF Medical Center-Mission Bay

    San Francisco, California, 94158, United States

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104, United States

  • VCU Massey Comprehensive Cancer Center

    Richmond, Virginia, 23298, United States

  • Women and Infants Hospital

    Providence, Rhode Island, 02905, United States

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