Last updated on February 2019

A Study of Coti-2 for the Treatment of Advanced or Recurrent Gynecologic Malignancies

Brief description of study

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.

Detailed Study Description

This is a single arm, single center, open-label, Phase 1, first time in human study of COTI-2 in patients with recurrent ovarian,fallopian tube,primary peritoneal cancer, endometrial, cervical or head and neck cancer. COTI-2 will be self-administered as a single agent, orally, once daily for 5 days followed by 2 treatment-free days each week.

Clinical Study Identifier: NCT02433626

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