XL-184+Abiraterone in Post-Chemo CRPC

Status: Recruiting
Phase: Phase 1
Diagnosis: Prostate Cancer
NCT ID: NCT01574937 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-441


This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it. It also means that the FDA (U.S. Food and Drug Administration) may not have approved this drug for use in participants, including people with your type of cancer. In this research study, we are testing the safety of XL184 at different dose levels. XL184 is a new study drug, which is taken by mouth. Laboratory studies have shown that XL184 may prevent tumor growth by stopping the formation of blood vessels inside the tumor and also shrink tumors. This drug has been used in early-stage studies and is also currently being studied in other trials. Information from those other research studies suggests that XL184 may help to slow or stop tumor growth including prostate cancer. We will also be taking blood and urine tests to look at how your body processes the drug.


Conducting Institutions:
Beth-Israel Deaconess Medical Center, Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital

Overall PI:
Glenn Bubley, MD, Beth Israel Deaconess Medical Center

Site-responsible Investigators:
Christopher Sweeney, Dana-Farber Cancer Institute
Richard J. Lee, MD, Massachusetts General Hospital

Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060
Dana-Farber Cancer Institute: Judith Prisby, 617-632-5068, jprisby@partners.org
Dana-Farber Cancer Institute: Amanda Fredericks, 617-632-5514, acfredericks@partners.org
Dana-Farber Cancer Institute: Meghara Walsh, 617-632-5264, mwalsh10@partners.org
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - CRPC with up to 2 prior chemotherapy regimens - Progressive disease on CT, MRI or bone scan per mRECIST - Has recovered to baseline/CTCAE less than or equal to Grade 1 from toxicities related to prior treatment (except alopecia) - Agree to use accepted barrier method of contraception Exclusion Criteria: - Cytotoxic chemotherapy within 3 weeks - Prior treatment with cabozantinib or other c-MET inhibitor - Prior therapy with a lyase inhibitor - Concurrent use of hormonal therapies other than LHRH analogue or orchiectomy - Received radiation therapy to thoracic cavity or GI tract within 3 months, to bone or brain metastasis within 2 weeks or to any other site within 4 weeks of first dose of study drug - Prior treatment with a small molecular kinase inhibitor within 2 weeks of study entry - Received another investigational product within 28 days prior to study entry - Active brain metastases or epidural disease - Requires concomitant treatment in therapeutic doses with warfarin or warfarin-related agents - No uncontrolled significant intercurrent or recent illness
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