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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: MEN2501 Dose Escalation | Experimental |
| |
| Part B: MEN2501 Dose Expansion & Optimization | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEN2501 | Drug | Oral tablet |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stemline Trials | Contact | 1-877-332-7961 | cwilliams@menarinistemline.com; MEN2501_StudyTeam@menarinistemline.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Stemline Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Highlands Oncology Group | Recruiting | Springdale | Arkansas | 72762 | United States | |
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Participants enrolled in the Part B dose expansion will be randomized between expansion doses.
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| 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 |
| Yale University |
| Recruiting |
| New Haven |
| Connecticut |
| 06519 |
| United States |
| Florida Cancer Specialists & Research Institute | Recruiting | Sarasota | Florida | 34232 | United States |
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
| Karmanos Cancer Institute | Recruiting | Detroit | Michigan | 48201 | United States |
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
| NEXT Virginia | Recruiting | Fairfax | Virginia | 22031 | United States |
| Icon Cancer Centre | Recruiting | South Brisbane | Queensland | 4101 | Australia |
| Cancer Research SA | Recruiting | Aberfoyle Park | 5000 | Australia |
| Hospital Universitario Dexeus - Grupo Quironsalud | Recruiting | Barcelona | 08028 | Spain |
| Clínica Universidad Navarra | Recruiting | Madrid | 28027 | Spain |
| Hospital Universitario 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
| Hospital Universitario HM Sanchinarro | Recruiting | Madrid | 28050 | Spain |
| Clínica Universidad de Navarra | Recruiting | Pamplona | 31008 | Spain |
| Hospital Quironsalud Madrid | Recruiting | Pozuelo de Alarcón | 28226 | Spain |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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