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
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 |
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
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 |