PLX038 for Treatment of Metastatic Platinum-resistant Ovarian, Primary Peritoneal, and Fallopian Tube Cancer
Phase II Clinical Trial of PLX038 in Patients With Platinum-Resistant Ovarian, Primary Peritoneal, and Fallopian Tube Cancer
4 other identifiers
interventional
43
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2022
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2022
CompletedFirst Posted
Study publicly available on registry
July 20, 2022
CompletedStudy Start
First participant enrolled
September 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2031
February 9, 2026
February 1, 2026
4.4 years
July 18, 2022
February 5, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of confirmed tumor responses
A confirmed tumor response is defined to be either a complete response or partial response noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. Confirmed tumor response will be evaluated using the first 6 cycles of treatment. All patients meeting the eligibility criteria who have signed a consent form, have begun treatment, and who have had at least one post-baseline tumor assessment will be evaluable for response. Patients not having met the criteria of having one post-baseline tumor assessment will be considered evaluable if they have discontinued the study due to disease progression.
Up to first 6 cycles of treatment (1 cycle = 21 days)
Secondary Outcomes (3)
Progression-free survival (PFS)
From study entry to the first of either disease progression or death from any cause, assessed up to 5 years
Overall survival (OS)
From study entry to death from any cause, assessed up to 5 years
Incidence of adverse event rates
Up to 30 days
Other Outcomes (5)
TOP1-deoxyribonucleic acid covalent complexes (TOP1cc)
Up to cycle 1 day 8 (1 cycle = 21 days)
Homologous recombination (HR) status
Up to cycle 1 day 8 (1 cycle = 21 days)
Protein expression
Up to cycle 1 day 8 (1 cycle = 21 days)
- +2 more other outcomes
Study Arms (1)
Treatment (pegylated SN-38 conjugate PLX038)
EXPERIMENTALPatients receive PLX038 IV over 1 hour on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, biopsy, as well as blood and stool sample collection during screening and on the trial.
Interventions
Undergo biopsy
Given IV
Undergo CT
Undergo blood and stool sample collection
Eligibility Criteria
You may qualify if:
- 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
- +4 more criteria
You may not qualify if:
- 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
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cancer Institute (NCI)collaborator
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea E. Wahner Hendrickson, M.D.
Mayo Clinic in Rochester
- PRINCIPAL INVESTIGATOR
Scott H. Kaufmann, M.D., Ph.D.
Mayo Clinic in Rochester
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Masking Details
- Staining will be read independently by two individuals blinded to treatment, who will score each sample for the percentage of cells that are positive for \>8 nucleoplasmic TOP1ccs.
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2022
First Posted
July 20, 2022
Study Start
September 14, 2022
Primary Completion (Estimated)
February 15, 2027
Study Completion (Estimated)
December 31, 2031
Last Updated
February 9, 2026
Record last verified: 2026-02