NCT02433626

Study of COTI-2 as Monotherapy or Combination Therapy for the Treatment of Malignancies

A Phase 1 Study of COTI-2 as Monotherapy or Combination Therapy for the Treatment of Advanced or Recurrent Malignancies

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: Critical Outcome Technologies Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 squamous cell carcinoma (HNSCC) as well as a variety of other tumor types. This study is designed primarily to assess the safety and tolerability of COTI-2 monotherapy or combination therapy in patients with advanced and recurrent malignancies to establish a recommended Phase 2 dose (RP2D) for future studies. Patients are currently being recruited for Part 3 of the study. Critical Outcome Technologies Inc. has been renamed to Cotinga Pharmaceuticals.

Detailed description

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), colorectal, lung, or pancreatic cancer. Other tumor types may be allowed with Sponsor approval. 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 be dose finding for COTI-2 in combination with cisplatin in patients with gynecological malignancies, HNSCC, colorectal, lung, pancreatic cancer, or other tumor types with Sponsor approval.

Conditions

• Ovarian Cancer
• Fallopian Tube Cancer
• Endometrial Cancer
• Cervical Cancer
• Peritoneal Cancer
• Head and Neck Cancer
• HNSCC
• Colorectal Cancer
• Lung Cancer
• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	COTI2	COTI-2 is a third generation thiosemicarbazone.
DRUG	Cisplatin	Cisplatin is approved to treat a range of solid tumors and lymphomas.

Timeline

• Start date: 2015-12-01
• Primary completion: 2019-12-01
• Completion: 2020-06-01
• First posted: 2015-05-05
• Last updated: 2019-02-01

Locations

1 site across 1 country: United States