RECRUITING

PLX038 for Treatment of Metastatic Platinum-resistant Ovarian, Primary Peritoneal, and Fallopian Tube Cancer

Conditions

Platinum-Resistant Fallopian Tube Carcinoma Platinum-Resistant Ovarian Carcinoma Platinum-Resistant Primary Peritoneal Carcinoma Stage IV Fallopian Tube Cancer AJCC v8 Stage IV Ovarian Cancer AJCC v8 Stage IV Primary Peritoneal Cancer AJCC v8

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase II trial tests whether pegylated SN-38 conjugate PLX038 (PLX038) works to shrink tumors in patients with ovarian, primary peritoneal, and fallopian tube cancers that has spread from where it first started (primary site) to other places in the body (metastatic). PLX038 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Official Title

Phase II Clinical Trial of PLX038 in Patients With Platinum-Resistant Ovarian, Primary Peritoneal, and Fallopian Tube Cancer

Quick Facts

Study Start:2022-09-14

Study Completion:2031-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05465941

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Clinical Trials Referral Office

CONTACT

855-776-0015

mayocliniccancerstudies@mayo.edu

Principal Investigator

Andrea E. Wahner Hendrickson, M.D.

PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Scott H. Kaufmann, M.D., Ph.D.

PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Study Locations (Sites)

Mayo Clinic

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Andrea E. Wahner Hendrickson, M.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester
Scott H. Kaufmann, M.D., Ph.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-14

Study Completion Date2031-12-31

Study Record Updates

Study Start Date2022-09-14

Study Completion Date2031-12-31

Terms related to this study

Additional Relevant MeSH Terms

Platinum-Resistant Fallopian Tube Carcinoma
Platinum-Resistant Ovarian Carcinoma
Platinum-Resistant Primary Peritoneal Carcinoma
Stage IV Fallopian Tube Cancer AJCC v8
Stage IV Ovarian Cancer AJCC v8
Stage IV Primary Peritoneal Cancer AJCC v8