Platinum-resistant Ovarian Cancer
Conditions
Keywords
MEN2501, First-in-Human, Ovarian Cancer
Brief summary
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.
Interventions
DRUGMEN2501
Oral tablet
Sponsors
Stemline Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants enrolled in the Part B dose expansion will be randomized between expansion doses.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Participants must have a histopathologically confirmed diagnosis of high-grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. Key
Exclusion criteria
* Participants with primary platinum-refractory disease. Note: Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A Only: Number of Participants with Dose-limiting Toxicities (DLTs) | Cycle 1 (28 days/cycle) |
| Part B Only: Recommended Phase 2 Dose (RP2D) of MEN2501 | Up to approximately 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants with Treatment-emergent Adverse Events | Up to approximately 7 months |
| Overall Response Rate | Up to approximately 7 months |
| Duration of Objective Response | Up to approximately 7 months |
| Clinical Benefit Rate | Up to approximately 7 months |
| Progression-free Survival | Up to approximately 12 months |
| Overall Survival | Up to approximately 12 months |
| Time To Response | Up to approximately 7 months |
| Area Under the Plasma Concentration-time Curve (AUC) of MEN2501 | Up to approximately 6 months |
Countries
Australia, Spain, United States
Contacts
CONTACTStemline Trials
STUDY_DIRECTORMedical Director
Stemline Therapeutics, Inc.
Outcome results
None listed