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New hope for Platinum-Resistant ovarian cancer: PLX038 trial launches

NCT ID NCT05465941

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 17, 2026 · Updated 4 times

Summary

This Phase II trial tests a drug called PLX038 in 43 people with ovarian, peritoneal, or fallopian tube cancer that has stopped responding to platinum-based chemotherapy. The drug works by blocking enzymes that help cancer cells grow. Researchers will check if it shrinks tumors and how long it keeps the cancer from progressing.

What this could mean

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

Active substance
PLX038 (a chemotherapy drug)
What this could lead to
If it works, this could offer a new treatment option for patients whose ovarian cancer has stopped responding to platinum-based chemotherapy.
What could go wrong
This is an early Phase II trial with only 43 participants, so results may not apply to everyone. The drug may cause side effects or fail to shrink tumors.

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

20 people

The number who actually took part.

Started

Sep 2022

Expected to finish

Feb 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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

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.

Inclusion Criteria: * Age \>= 18 years NOTE: Because no dosing or adverse event data are currently available on the use of PLX038 in patients \< 18 years of age, children are excluded from this study, but will be eligible for future pediatric trials * Histological confirmed high grade serous ovarian cancer consistent with ovarian, fallopian tube, or primary peritoneal carcinoma (NOTE: Any of these diseases are referred to in this protocol as "ovarian cancer") * Recurrent high grade serous ovarian cancer that was initially platinum sensitive (i.e., had at least one platinum-free interval of at least 6 months before progression) is now platinum resistant * No more than one prior line of therapy for platinum resistant disease. NOTE: Prior poly adenosine diphosphate-ribose polymerase (PARP) inhibitor therapy is allowed * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 * Disease that is amenable to two biopsies * Life expectancy greater \>= 12 weeks * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2 * Hemoglobin \>= 8.0 g/dL (obtained =\< 28 days prior to registration) * Absolute neutrophil count (ANC) \>= 1500/mm\^3 (obtained =\< 28 days prior to registration) * Platelet count \>= 100,000/mm\^3 (obtained =\< 28 days prior to registration) * Total bilirubin \>= 1.5 x upper limit of normal (ULN) (obtained =\< 28 days prior to registration) * Alanine aminotransferase (ALT) and aspartate transaminase (AST) =\< 3 x ULN (=\< 5 x ULN for patients with liver involvement) (obtained =\< 28 days prior to registration) * Calculated creatinine clearance \>= 45 ml/min using the Cockcroft-Gault formula (obtained =\< 28 days prior to registration) * Negative pregnancy test done =\< 7 days prior to registration, for persons of childbearing potential only * Provide written informed consent * Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study) * Willingness to provide mandatory blood specimens for correlative research * Willingness to provide mandatory tissue specimens for correlative research Exclusion Criteria: * Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects: * Pregnant persons * Nursing persons * Persons of childbearing potential who are unwilling to employ adequate contraception * Histology other than high grade serous carcinoma * Prior treatment restrictions * Chemotherapy =\< 4 weeks prior to registration * Immunotherapy =\< 4 weeks prior to registration * Radiotherapy =\< 4 weeks prior to registration * Any other investigational therapy =\< 4 weeks prior to registration * History of prior or concurrent malignancy =\< 2 years prior to registration * Exceptions: If natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen * Uncontrolled intercurrent illness including, but not limited to: * Myocardial infarction within 6 months of study entry * New York Heart Association (NYHA) class III or IV heart failure * Uncontrolled dysrhythmias or poorly controlled angina * History of serious ventricular arrhythmia (ventricular tachycardia \[VT\] or ventricular fibrillation \[VF\]) and/or factors that predispose to arrhythmia (e.g., heart failure, hypokalemia, family history of long QT syndrome) * Known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, Exception: Patients 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 IIB or better Exception: Patients who have received prior doxorubicin (Doxil) are eligible if asymptomatic with QTc =\< 480msec (Fridericia) and NYHA class IIB or better * Known human immunodeficiency virus (HIV) Exception: Patients on effective anti-retroviral therapy with undetectable viral load =\< 6 months prior to registration are eligible for this trial * Known hepatitis * Exception: For patients with evidence of chronic hepatitis B virus infection the HepB viral load must be undetectable on suppressive therapy, if indicated, to be eligible * Exception: Patients with a history of hepatitis C virus infection must have been treated and cured. Patients with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load * Receiving any other investigational agent * History of clinically significant gastrointestinal bleeding, colitis, or gastrointestinal perforation * Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens * Requirement for anticoagulation treatment that increases international normalized ratio (INR) or activated partial thromboplastin time (APTT) above the normal range (Exceptions: low dose deep vein thrombosis \[DVT\] or line prophylaxis allowed) * Known central nervous system (CNS) disease Exception: Patients with treated brain metastases are eligible if follow-up brain imaging after CNS directed therapy shows no evidence of progression. Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determined that immediate CNS specific treatment is not required and is unlikely to be required during the 1st cycle of therapy * Known Gilbert's syndrome or homozygous for the UGT1A1\*28 variant allele or other relevant alleles with severely reduced UGT1A1 activity * Patients who require treatment with UGT1A1 inhibitors during the planned period of investigational treatment with PLX038

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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

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.