A Phase II Study of MEN2501 in Patients with Platinum-Resistant Ovarian Cancer
- Trial ID
- 2025-524168-39-00
- Protocol
- MEN2501-01
- Sponsor
- Stemline Therapeutics Inc.
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this study is to evaluate the efficacy of MEN2501 in patients diagnosed with platinum-resistant ovarian cancer. This investigation is clinically significant for addressing therapeutic options in cases where standard chemotherapy has failed to maintain remission.
Participants
The study population consists of 97 female patients diagnosed with platinum-resistant ovarian cancer. Based on the provided age range codes, the participants are within the age groups categorized as 3 and 4. The sponsor did not provide additional information regarding lifestyle considerations or specific selection methodologies.
Plans and Procedures
This Phase 1 clinical trial is designed to evaluate the efficacy and safety of MEN2501 in patients diagnosed with platinum-resistant ovarian cancer. The study utilizes a controlled research methodology to assess the investigational product. The clinical process begins with a screening visit to determine eligibility based on predefined criteria. Following successful screening, participants proceed through scheduled follow-up visits to monitor clinical responses and safety parameters. The protocol concludes with an end-of-study visit. The total duration of the study is estimated to span from April 2026 to July 2028. Individual involvement may be subject to early termination should specific clinical conditions or safety protocols be met.
Treatment
Efficacy
The assessment of efficacy in this Phase 1 clinical trial involves the evaluation of outcomes related to platinum-resistant ovarian cancer. Specific parameters and methods for determining clinical response are not specified in the provided data.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
Spain | Recruiting | 30 Apr 2026 | 23 |

