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Purpose

This is a first-in-human, open-label, dose-escalation, dose-optimization trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of MEN2501 monotherapy in adult participants with platinum-resistant ovarian cancer.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participants must have a histopathologically confirmed diagnosis of high-grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.

Exclusion Criteria

  • Participants with primary platinum-refractory disease. Note: Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Participants enrolled in the Part B dose expansion will be randomized between expansion doses.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part A: MEN2501 Dose Escalation
  • Drug: MEN2501
    Oral tablet
Experimental
Part B: MEN2501 Dose Expansion & Optimization
  • Drug: MEN2501
    Oral tablet

Recruiting Locations

Highlands Oncology Group
Springdale, Arkansas 72762

Yale University
New Haven, Connecticut 06519

Florida Cancer Specialists & Research Institute
Sarasota, Florida 34232

Karmanos Cancer Institute
Detroit, Michigan 48201

Mayo Clinic
Rochester, Minnesota 55905

NEXT Virginia
Fairfax, Virginia 22031

More Details

Status
Recruiting
Sponsor
Stemline Therapeutics, Inc.

Study Contact

Stemline Trials
1-877-332-7961
cwilliams@menarinistemline.com; MEN2501_StudyTeam@menarinistemline.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.