Study of COTI-2 for the Treatment of Gynecologic Malignancies and Head and Neck Squamous Cell Carcinoma (COTI2-101)
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|ClinicalTrials.gov Identifier: NCT02433626|
Recruitment Status : Recruiting
First Posted : May 5, 2015
Last Update Posted : February 6, 2018
Activity of COTI-2 has been demonstrated in various cancer tumor models. With its p53- and AKT-based mechanisms of action, COTI-2 is anticipated to be highly relevant in treatment of patients with gynecologic malignancies or head and neck suamous cell carcinoma (HNSCC).
This study is designed primarily to assess the safety and tolerability of COTI-2 in patients with advanced and recurrent gynecologic malignancies and HNSCC to establish a recommended Phase 2 dose (RP2D) for future studies.
Patients are currently being recruited for Part 2 of the study.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Fallopian Tube Cancer Endometrial Cancer Cervical Cancer Peritoneal Cancer Head and Neck Cancer HNSCC||Drug: COTI2||Phase 1|
This is a three-part, multi-center, open-label, Phase 1, first-in-patient study of COTI-2 in patients with recurrent ovarian, fallopian tube, primary peritoneal, endometrial, or cervical cancer (collectively gynecological malignancies), and in patients with head and neck squamous cell carcinoma (HNSCC).
COTI-2 will be self-administered as a single agent, orally, once daily for 5 days followed by 2 treatment-free days each week.
Part 1 of the study will be dose finding in patients with gynecological malignancies using a 3 + 3 design to establish the MTD (maximum tolerated dose) over 6 planned cohorts.
Part 2 of the study will be dose finding in patients with HNSCC using a 3 + 3 design to establish the MTD over 6 planned cohorts.
Part 3 of the study will enrol a further 10 Ovarian and 10 HNSCC participants to further establish tolerability and efficacy at the MTD.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of COTI-2 for the Treatment of Advanced or Recurrent Gynecologic Malignancies and Head and Neck Squamous Cell Carcinoma|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02433626
|Contact: Chris Lynamemail@example.com|
|United States, Illinois|
|Northwestern Memorial Hospital||Recruiting|
|Chicago, Illinois, United States|
|Contact: Wilberto Nieves-Neira, MD 312-472-4684|
|Principal Investigator: Wilberto Nieves-Neira, MD|
|United States, Texas|
|MD Anderson Cancer Centre||Recruiting|
|Houston, Texas, United States|
|Contact: Shannon Westin, MD 713-794-4314|
|Principal Investigator: Shannon Westin, MD|