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

NCT02433626 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2019-02-01

No results posted yet for this study

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.

Conditions

Interventions

DRUG

COTI2

COTI-2 is a third generation thiosemicarbazone.

DRUG

Cisplatin

Cisplatin is approved to treat a range of solid tumors and lymphomas.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • Northwestern Memorial Hospital

    collaborator OTHER

  • Critical Outcome Technologies Inc.

    lead INDUSTRY

Principal Investigators

  • Shannon Westin, MD · MD Anderson

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2019-12-31
Completion
2020-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02433626 on ClinicalTrials.gov