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Phase 1 Study of Oral Drug PMD-026 in People With Metastatic Breast Cancer and Metastatic Triple Negative Breast Cancer

Phase 1 Study of Oral Drug PMD-026 in People With Metastatic Breast Cancer and Metastatic Triple Negative Breast Cancer

Clinicaltrials.gov identifier:
NCT04115306

Treatment:
Breast

Study Contact Information:

For more information about the study, visit https://phoenixmd.ca/clinical-trials.

Phase 1/1b Study of Oral Drug PMD-026 in People with Metastatic Breast Cancer and Metastatic Triple Negative Breast Cancer

About the Study

PMD-026 is a study for people who have been diagnosed with metastatic triple negative breast cancer (mTNBC) who have no further treatment options. This research study is investigating if a study drug called PMD-026 is safe and effective for patients with mTNBC.

Type of Study

This is a Phase 1/1b, study of a new oral drug called PMD-026. This drug is not a chemotherapy. The goal is to assess if PMD-026 is safe and effective. 

  • The agent, PMD-026 is taken orally. 
  • There is no placebo, everyone in the study will receive the study agent. 

What the Study Entails

  • Women and men with a diagnosis of metastatic triple negative breast cancer may be screened for eligibility
  • Participants will be asked to take two capsules by mouth, twice a day (total 4 capsules daily)
  • Participants will be asked to take two capsules with food once to determine if food helps with absorption of PMD-026
  • Participants will have 3 weekly clinic visits for health assessments and blood tests in the first treatment cycle, and minimum one visit per cycle thereafter (Each cycle is 21 days)
  • CT/MRI scans to assess disease are scheduled for the first 2 cycles then every 9 weeks thereafter
  • Participants will receive a safety follow-up approximately 28 days after their last dose
  • Once a patient has completed the treatment, and if they did not develop progressive disease while on PMD-026, the study staff will follow up on the patient’s status on a regular basis for up to one year. The follow up will not require a clinic visit, as the study staff can either check the medical record or call the patient

Study Sites

The study is open in the following states

Arizona

  • Gilbert: Banner Health MD Anderson; Study PI: Dr. Lida Mina
    Contact: Toni Korpela 480-256-5464 or by email
  • Tucson: University of Arizona; Study PI: Dr. Pavani Chalasani;
    Contact: Alexia Demitsas 520-694-9089 or by email

California

  • Los Angeles: University of California, Los Angeles; Study PI: Dr. Sara Hurvitz;
    Contact: Monica Rocha 310-998-4747 ext 16907 or by email
  • San Diego: University of California, San Diego; Study PI: Dr.Rebecca Shatsky;
    Contact: Haifa Mshaiel 858-822-4343 or by email 
    Sauntee Braddock 858-534-8248 or by email 

Florida

  • Sarasota: Florida Cancer Specialists; Study PI: Dr. Judy Wang;
    Contact: 941-377-9993 or by email 
  • Tampa: Moffitt Cancer Center; Study PI: Dr. Hyo (Heather) Han; Contact: TBD

New York

  • New York: Columbia University; Study PI: Dr. Meghna Trivedi;
    Contact: Brianne Bodin or by email

Ohio

  • Columbus: Ohio State University; Study PI: Dr. Robert Wesolowski;
    Contact: Robert Wesolowski by email

Texas

  • San Antonio: South Texas Accelerated Research Therapeutics; Study PI: Dr. Muralidhar Beeram; Contact: Isabel Jimenez 210-593-5265 or by email 

For more information about the study, visit https://phoenixmd.ca/clinical-trials.

This Study is Open To:

Women and men with measurable metastatic triple negative breast cancer if they are:

  • at least 18 years old;
  • willing to provide blood and tumor tissue samples for testing;
  • progression on or after standard of care therapy;
  • resolved treatment related toxicity;
  • adequate immune, liver, kidney function;
  • no available standard of care therapy that would confer clinical benefit;
  • otherwise in reasonably good health.
This Study is Not Open To:

Women and men who have the below:

  • a minimum of 14 days from prior chemotherapy, biological, or investigational therapy;
  • use of medication that is known to prolong QT/QTc interval, induces CYP3A, substrate of BCRP and MATE2K;
  • known history of leptomeningeal metastases;
  • brain metastases, unless appropriately treated and neurologically stable;
  • pregnant or breast-feeding;
  • active bacterial, viral, or fungal infection(s) requiring systemic therapy including Hepatitis B, Hepatitis C, HIV+;
  • other known active cancer(s);
  • active gastrointestinal disease or other condition that is expected to interfere significantly with oral therapy;
  • history of clinically significant cardiovascular abnormalities.