A Study of Coti-2 for the Treatment of Advanced or Recurrent Gynecologic Malignancies (COTI2-101)
Activity of COTI-2 has been demonstrated in the OVCAR-3 ovarian cancer tumor model. With its p53- and AKT-based mechanisms of action, COTI-2 is anticipated to be highly relevant in treatment of patients with gynecologic malignancies.
This study is designed primarily to assess the safety and tolerability of COTI-2 in patients with advanced and recurrent gynecologic and head and neck malignancies and to establish a recommended Phase 2 dose (RP2D) for future studies.
|Ovarian Cancer Fallopian Tube Cancer Endometrial Cancer Cervical Cancer Peritoneal Cancer Head and Neck Cancer||Drug: COTI2||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||A Phase 1 Study of COTI-2 for the Treatment of Advanced or Recurrent Gynecologic Malignancies.|
- Number of dose limiting Toxicities [ Time Frame: 12 months ]Used to measure safety and tolerability of COTI2
- Tmax [ Time Frame: 6 months ]To determine maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D)
- Clinical response [ Time Frame: 6 Months ]This will be assessed through CT imaging, measurement using RECIST 1.0 criteria and GCIG criteria (if applicable)
- Progression Free survival [ Time Frame: 12 months ]This will be assessed through CT imaging and measurement using RECIST 1.0 criteria.
|Study Start Date:||December 2015|
|Estimated Study Completion Date:||December 2018|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
COTI-2 will be self-administered as a single agent, orally, once daily for 5 days followed by 2 treatment-free days each week; 1 cycle will be defined as 4 weeks of treatment as described (5 days on, 2 days off per week). Participants will remain on treatment until they experience a lack of benefit.
COTI-2 is a third generation thiosemicarbazone.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02433626
|Contact: Ashley ten Haafemail@example.com|
|United States, Illinois|
|Northwestern Memorial Hospital||Recruiting|
|Chicago, Illinois, United States|
|Principal Investigator: Wilberto Nieves-Neira, MD|
|United States, Texas|
|MD Anderson Cancer Centre||Recruiting|
|Houston, Texas, United States|
|Principal Investigator: Shannon Westin, MD|