Cabozantinib in Advanced Solid Malignancies

Status: Recruiting
Phase: Phase 2
Diagnosis: Lung Cancer
NCT ID: NCT01588821 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-091

 

This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it-such as the safest dose to use, the side effects it may cause, and if the drug is effective for treating different types of cancer. It also means that the FDA has not approved the drug for this type of cancer, or for any use outside of research studies. When cancer spreads from the primary tumor, one of the most commons sites it spreads to is bone. When cancer spreads to bone there can be significant symptoms such as pain. Cabozantinib works by blocking signaling that leads to cancer growth as well as blocking the growth of new blood vessels (angiogenesis) that help to feed a tumor. Cabozantinib has been studied or is being studied in research studies as a possible treatment for various types of cancer, including prostate cancer, brain cancer, thyroid cancer, lung cancer and kidney cancer. Previous clinical research studies indicate that cabozantinib may also have activity against cancer once it has spread to the bones. The purpose of this study is to find out if cabozantinib is effective in treating cancer that has spread to the bone.

 

Conducting Institutions:
Massachusetts General Hospital, Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Rebecca Heist, MD, Massachusetts General Hospital

Site-responsible Investigators:
Bruce Johnson, MD, Dana-Farber Cancer Institute

Contacts:
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute: Kelly Masone, 617-632-3383, kmasone@partners.org

Eligibility Criteria

Inclusion Criteria: - Histologic or cytologic diagnosis of a solid tumor (not breast or prostate) that is metastatic and refractory to or progressed following standard therapies - Has bony metastases - Agree to use medically accepted methods of contraception Exclusion Criteria: - Pregnant or breastfeeding - Received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents within 3 weeks of study entry(6 weeks for nitrosoureas/mitomycin C) - Received radiation to the thoracic cavity/GI tract (within 3 months of study entry), to bone or brain metastasis (within 14 days) or to any other site within 28 days - Received prior treatment with small molecule kinase inhibitor or hormonal therapy within 14 days/5 half-lives - Received therapy with another investigational agent within past 28 days - Recovered from toxicities due to prior therapies - Primary brain tumor - Active brain metastases or epidural disease - Uncontrolled significant intercurrent or recent illness - Allergy or hypersensitivity to components of the study treatment formulation
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