New drug combo shows promise against resistant ovarian cancer

NCT ID NCT04374630

Disease control Sponsor: Laekna Limited Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This Phase 2 trial tested whether adding afuresertib (an AKT inhibitor) to standard paclitaxel chemotherapy helps control platinum-resistant ovarian cancer better than paclitaxel alone. 150 women with this difficult-to-treat cancer participated. The study measured how long the cancer stayed under control and overall survival.

What this could mean

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

Active substance: Afuresertib (an AKT inhibitor) plus paclitaxel chemotherapy
What this could lead to: If successful, this combination could offer a new treatment option to slow cancer progression in patients with platinum-resistant ovarian cancer.
What could go wrong: This is a Phase 2 trial with only 150 participants, so results may not confirm effectiveness. Side effects from the drug combination are possible and need further study.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

150 people

The number who actually took part.

Started

Jun 2020

Finished

Jun 2024

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 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: 1. 1\. Female patients at least 18 years of age at the time of signing the informed consent form and capable of giving written informed consent, which includes willingness to comply with the requirements and restrictions listed in the consent form. 2. Must provide informed consent for the procedures and the tests for PI3K/AKT/PTEN pathway alterations, BRCA1/2 mutations, and/or level of phospho-AKT. The archival tumor biopsy sample collected less than 1 year is preferred. If no archival tumor sample is available, fresh biopsy will be recommended. For patients who cannot provide a tumor sample or cannot accept fresh tumor biopsy, the Sponsor should be consulted about their qualification to enter this study. 3. Patients must have histologically or cytologically confirmed high grade serous OC, endometroid OC, or ovarian clear cell carcinoma (including fallopian tube and primary peritoneal cancers). Carcinosarcoma, sarcoma, mucinous OC, or low-grade serous OC or the other histologies must be excluded. 4. Must not have previously received prior AKT or PI3K pathway or mTOR inhibitors. 5. Must have PROC (including fallopian tube and primary peritoneal carcinoma), defined as disease relapsed between 1 to 6 months after the last dose of the first-line platinum-based therapy (at least 3 cycles), or progressed during or relapsed within 6 months of the last dose of platinum-based 2nd-5th line therapies. 6. The OC patients must have received 1 to 5 prior chemotherapies including no more than one chemotherapy after PROC was diagnosed. Combination therapy with two or more drugs will be considered as one therapy, whereas maintenance therapy will be considered as continuation of the previous systemic treatment. 7. Patients should be appropriate candidates for treatment with single agent weekly paclitaxel based on investigator's clinical assessment. 8. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 9. Must meet the following criteria for hematology parameters: * Absolute neutrophil count (ANC) ≥ 1,500/mm3 * Platelets ≥ 100,000/µL * Hemoglobin ≥ 9.0 g/dL 10. Total serum bilirubin ≤ 1.5 × upper limit of normal (ULN) (in patients with known Gilbert's syndrome, total bilirubin ≤ 3 × ULN with direct bilirubin ≤ 1.5 × ULN). 11. Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase \[SGPT\]) must be \< 2.5 × institutional ULN. For patients with liver metastasis, AST/ALT must be \< 5.0 × institutional ULN. 12. Creatinine within 1.5 × ULN or creatinine clearance \> 30 mL/min by Cockcroft Gault formula (Appendix 1). 13. Toxicities of prior therapy (except alopecia) should have been resolved to less than or equal to grade 1 as per NCI-CTCAE v5.0. 14. Patients must have GI functions that would allow absorption of afuresertib. 15. Patient must have a life expectancy of greater than 6 months. 16. Must have at least one lesion that meets the definition of measurable disease by RECIST 1.1 criteria (Appendix 3). 17. Patients of childbearing potential must agree to use adequate contraception (barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she should inform her treating physician immediately. 18. Must be off strong inhibitors or inducers of CYP3A4/5 treatment, as showed in Appendix 2, for at least 2 weeks from Study Day 1. Exclusion Criteria: 1. 1\. Primary platinum refractory disease, defined as "disease progression during or relapsed within 1 month after the last dose of the first-line platinum based therapy". 2. Known or suspected brain metastases. 3. Receiving any other anticancer therapeutic agents other than study medicines. 4. Uncontrolled ascites. 5. Known symptomatic or impending cord compression, except if the patient has received definitive treatment for this and demonstrates evidence of clinically stable disease. 6. Presence of other active cancer within 3 years prior to enrollment (other than basal cell or squamous cell skin cancer, or any other cancer in situ currently in complete remission). 7. History of seizure or condition that may predispose to seizure that needs anti-epileptic medications; brain arteriovenous malformation; or intracranial masses, such as schwannomas and meningiomas that are causing edema or mass effect. 8. Known allergies, hypersensitivity, or intolerance to the excipients of afuresertib (for excipient information, refer to the IB17). 9. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (eg, compromise well-being) or that could prevent, limit, or confound the protocol-specified assessments. 10. Any medical contraindication to the use of paclitaxel. 11. Prior radiotherapy ≤ 15 days prior to Study Day 1, with the exception of a single fraction of radiotherapy for the purposes of palliation, which is permitted. 12. History of clinically significant ventricular arrhythmias (eg, ventricular tachycardia, ventricular fibrillation, or torsade de pointes). 13. Prolonged corrected QT interval by the Fridericia's correction formula (QTcF) on the screening ECG \> 470 msec. Receiving concomitant medications known to prolong QTc, or which are associated with torsade de pointes, and are unable to discontinue use while receiving study drug. 14. History or evidence for any of the following: severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks) within 6 months prior to Study Day 1 or New York Heart Association Class III to IV heart disease. 15. Presence of uncontrolled hypertension (systolic blood pressure \[BP\] \> 160 mmHg or diastolic BP \> 100 mmHg). Patients with a history of hypertension are allowed, provided that BP is controlled to within these limits by anti-hypertensive treatment. 16. Human immunodeficiency virus (HIV)-positive patients with 1 or more of the following: 1. Not receiving highly active antiretroviral therapy 2. Receiving antiretroviral therapy that may interfere with the study drug (consult the Sponsor for review of medication prior to enrollment) 3. CD4 count \< 350 based on a test within 3 months of the screening visit 4. An acquired immunodeficiency syndrome-defining opportunistic infection within 6 months of the start of screening 17. Had a major surgery ≤ 30 days prior to first study treatment at Cycle 1 Day 1. 18. Presence of grade \> 2 neuropathy. 19. Prior receipt of chemotherapy, PARP inhibitor, bevacizumab, or investigational therapy within 28 days of enrollment or within 5 half lives of the agent, whichever is shorter. 20. Patients who are pregnant or lactating. 21. Patients with high risk of tuberculosis infection, based on investigator's clinical assessment, will be screened by tuberculosis screening test, such as the QuantiFERON® TB Gold In Tube test (QFT-GIT) or the T-SPOT®.TB test (T-Spot). 22. Patients with active hepatitis B (positive hepatitis B surface antigen \[HBsAg\] test at screening) or hepatitis C (positive hepatitis C virus \[HCV\] antibody test at screening) are not allowed to be enrolled in this study. Note: * Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HBsAg test and a positive hepatitis B core antibody \[HBcAb\] test) are eligible. * Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.

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Conditions

The condition(s) this trial relates to.

fallopian tube carcinoma ovarian cancer ovarian carcinoma ovarian clear cell 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.

Platinum-resistant ovarian cancer

Contacts and locations

Locations

Abington Memorial Hospital

Willow Grove, Pennsylvania, 19090, United States
Arizona Oncology

Tucson, Arizona, 85711, United States
Arizona Oncology Associates

Phoenix, Arizona, 85016, United States
Baylor Scott & White Medical Center

Temple, Texas, 76508, United States
Beijing Obstetrics & Gynecology Hospital, Capital Medical University

Beijing, China
Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China
Chongqing University Cancer Hospital

Chongqing, China
Gynecology Oncology Associates Newport Beach

Newport Beach, California, 92663, United States
Harbin Medical University Cancer Hospital

Heilongjiang, China
Henan Cancer Hospital

Henan, China
Highlands Oncology Group

Rogers, Arkansas, 72758, United States
Holy Name Medical Center

Teaneck, New Jersey, 07666, United States
Houston Methodist Hospital

Houston, Texas, 77030, United States
Hubei Cancer Hospital

Hubei, China
Hunan Cancer Hospital

Hunan, China
Jilin Cancer Hospital

Jilin City, China
Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States
Liaoning Cancer Hospital

Liaoyang, China
MD Anderson Cancer Center at Cooper

Camden, New Jersey, 08103, United States
Montefiore Medical Center

The Bronx, New York, 10467, United States
Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States
OHCare Oncology Hematology Care (OHC), Inc. - Kenwood Office

Cincinnati, Ohio, 45242, United States
Obstetrics & Gynecology Hospital of Fudan University

Shanghai, China
Peking University Cancer Hospital

Beijing, China
Qilu Hospital of Shandong University

Shandong, China
Rocky Mountain Cancer Centers

Littleton, Colorado, 80120, United States
Southwest Women's Oncology Group

Albuquerque, New Mexico, 87106, United States
Sun Yat-sen University Cancer Center

Guangdong, China
Texas Oncology

Austin, Texas, 78731, United States
Texas Oncology

Fort Worth, Texas, 76104, United States
Texas Oncology

The Woodlands, Texas, 77380, United States
The Second Hospital of Tianjin Medical University

Tianjin, China
Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States
Tufts Medical Center

Boston, Massachusetts, 02111, United States
US Texas Oncology

San Antonio, Texas, 78240, United States
USO Texas Oncology

Longview, Texas, 75601, United States
University of Chicago

Chicago, Illinois, 60637, United States
University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States
University of Massachusetts

Worcester, Massachusetts, 01605, United States
University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States
University of Washington/Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States
Virginia Oncology Associates

Norfolk, Virginia, 23502, United States
West China Second University Hospital,Sichuan University

Sichuan, China
Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States
Women's Cancer Care

Covington, Louisiana, 70433, United States
Women's Hospital school of medicine Zhejiang University

Zhejiang, China
Zhongshan Hospital affiliated to Fudan University

Shanghai, China

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