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A Phase 2 Study of Kevetrin in Subjects With Ovarian Cancer

NCT03042702 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2018-12-27

Study results available
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Summary

Cellceutix has developed Kevetrin (thioureidobutyronitrile), belonging to an anti-proliferative p53 activator pharmacological class, for the treatment of cancer. Nonclinical studies have demonstrated that Kevetrin induces apoptosis by activation of wild type p53 and induces apoptosis in mutant p53 cells by degradation of oncogenic mutant p53.

In this Phase 2 study, two different short-term treatment regimens of Kevetrin will be evaluated for safety, tolerability, changes in biomarkers/objective tumor response, and to evaluate the pharmacokinetics of Kevetrin when administered to subjects with platinum-resistant/refractory ovarian cancer.

Conditions

Interventions

DRUG

Kevetrin

Kevetrin dose to associated cohort

DRUG

Kevetrin

Kevetrin dose to associated cohort

Sponsors & Collaborators

  • Innovation Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Arthur Bertolino, MD · Cellceutix Corporation

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-09
Primary Completion
2017-11-10
Completion
2017-11-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT03042702 on ClinicalTrials.gov