Clinical Trial TitleA phase 2, multi-arm, multicenter, open-label study to evaluate the efficacy and safety of IPI-549 administered in combination with front-line treatment regimens in locally advanced and/or metastatic triple-negative breatst cancer or renal cell carcinoma.
National Clinical Trial Number:NCT03961698
Clinical Trial Protocol Description:
The purpose of this study is to study the effect and safety of an investigational drug called IPI-549 when it is given with the drugs atezolizumab and nab-paclitaxel. Research data from animal studies suggest that IPI-549 may be useful in treating advanced and/or metastatic triple-negative breast cancer (TNBC). An “investigational drug” means that the drug being tested has not been approved by the United States (US) Food and Drug Administration (FDA) for the treatment of your disease. Atezolizumab in combination with Nab-paclitaxel has been approved by the FDA to treat some patients with a kind of breast cancer.
Participation in this study may last up to 2 years and participants will be asked to come to the clinic for study visits about once a week while they are receiving study treatment.
During these visits, participants will be asked to answer questions about their health, undergo lab tests and physical examinations, and provide blood and tissue samples.
More information can be found on the website clinicaltrials.gov by searching for NCT03961698.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are at least 18 years of age at enrollment.
- Are a woman with metastatic or locally advanced (not amenable to resection with curative intent), histologically documented TNBC, i.e., absence of human epidermal growth factor receptor 2 (HER2), estrogen receptor (ER) and progesterone receptor (PR) expression.
- Are willing to undergo one pre-treatment core biopsy (unless archival tumor tissue is available within 3 months of first dose) and one on-treatment tumor biopsy, unless not safe or medically feasible.
- Have had no prior chemotherapy or targeted systemic therapy for inoperable locally advanced or metastatic TNBC. Radiation therapy for metastatic disease is permitted.
You will be excluded from the study if any of the following criteria apply to you:
- Have any history of, or have currently active, brain or leptomeningeal metastases.
- Have had a positive test for human immunodeficiency virus (HIV) or active hepatitis B or hepatitis C infection.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.