Phase 1/1b Multi-center, Open-Label, First-in-Human Dose Escalation and Dose Expansion Study to Assess Safety and Tolerability of Orally Administered PMD-026 in Patients with Metastatic Breast Cancer with Expansion in Metastatic Triple Negative Breast Cancer
Study of PMD-026 in Patients with Metastatic Breast Cancer with Expansion in Metastatic Triple Negative Breast Cancer
Sponsor: Phoenix Molecular Designs
Enrolling: Male and Female Patients
IRB Number: AAAS8152
U.S. Govt. ID: NCT04115306
Contact: Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu
Additional Study Information: This is a first-in-human, phase 1/1b, open-label study of single-agent PMD-026 conducted in participants with metastatic breast cancer. PMD-026 will initially be administered orally on a once-daily schedule. Part 1 of the study will evaluate PMD-026 in participants with metastatic breast cancer that have not responded to treatment, which may involve increasing the dose of PMD-026 as this part of the study progresses. Part 2 of the study will evaluate participants with metastatic triple-negative breast cancer using the dose determined in Part 1.
This study is closed
Investigator
Meghna Trivedi, MD
Do You Qualify?
Are you age 18 years or older? Yes No
Do you have confirmed diagnosis of metastatic breast cancer or metastatic triple negative breast cancer? Yes No
Have you ever had therapy for your breast cancer? Yes No
Are you able to provide a tissue sample from a previous biopsy, or undergo a biopsy procedure to collect new tissue? Yes No
Do you have hepatitis B or C? Yes No
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For more information, please contact:
Research Nurse Navigator
cancerclinicaltrials@cumc.columbia.edu
212-342-5162