Clinical Trials Search
Clinical Trial 20404
Cancer Type: Breast
Study Type: Treatment
NCT#: NCT03363893
Phase: Phase I/II
Prinicipal Investigator: Heather Han
Study Title
A Modular, Multipart, Multi-arm, Open-label, Phase 1/2a Study to Evaluate the Safety and Tolerability of CT7001 Alone and in Combination with Anti-Cancer Treatments in Patients with Advanced Malignancies
Summary
This is a modular, Phase I/II, multicentre study to investigate CT7001 monotherapy in advanced solid malignancies and to further investigate CT7001 as monotherapy or in combination with standard therapy in specific participant groups with Triple Negative Breast Cancer (TNBC), Castrate Resistant Prostate Cancer (CRPC) and in combination with fulvestrant for patients with hormone receptor-positive (HR+ve) / human epidermal growth factor-2 negative (HER2-ve) breast cancer.
Objective
Primary Objective, study Part A To determine the recommended Phase 2 dose of CT7001 given in combination with fulvestrant at 500 mg. Primary Objective, study Part B To compare the efficacy of CT7001 given in combination with fulvestrant versus fulvestrant plus placebo. Primary Objective, study Part C To evaluate the efficacy of CT7001 combined with fulvestrant in patients whose disease had progressed on or after fulvestrant plus placebo in Part B of the study
Therapies
Medications
CT7001 (); Faslodex (fulvestrant); Placebo (); fulvestrant ()
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