Clinical Trial DRUG CTKI258AUS26
- Modular Phase II Study to Link Targeted Therapy to Patients with Pathway Activated Tumors: Module 2 - Dovitinib for Patients with Tumor Pathway Activations Inhibited by Dovitinib Including Tumors with Mutations or Translocations of FGFR, PDGFR, VEGF, CKIT, FLT3, CSFR1, TRK and RET
- Principal Investigator
- Young Chae
- Status: COMPLETED
- Study Type: Therapeutic, Treatment
- Protocol No:.DRUG CTKI258AUS26
- Researchers want to know if dovitinib (TKI258) is safe and has beneficial effects in people who have different tumor types (cancer) and/or blood malignancies whose disease progressed after standard treatment.
- Dovitinib (TKI258) is a drug that is being developed for the potential treatment of different tumor types (cancer), and/or blood malignancies. Dovitinib (TKI258) is an inhibitor of Receptor tyrosine kinases (RTKs): it blocks the activity of three RTKs (VEGF, FGF and PDGF) involved in tumor cell growth. So far, at least 1158 people with different types of tumors have received dovitinib (TKI258), either alone or in combination with another anti-cancer drug.
Some of the eligibility criteria include:
- Participants must be at least 18 years of age.
- Participants must have a confirmed diagnosis of a select solid tumor (except for urothelial tumors, hepatocellular carcinoma, endometrial carcinoma, metastatic breast cancer, squamous non-small cell lung cancer, and renal cell carcinoma) or hematologic malignancy (except for certain types of acute myeloid leukemia and multiple myeloma).
- Participants must need treatment because their cancer is getting worse.
- Participants must have a tumor with a mutation in FGFR 1-3, PDGFRa or PDGFRß, VEGFR1-2 (KDR), FLT3, cKIT, RET, TrkA (NTRK1), or CSF-1R. This is determined by genetic testing.
- Description of Treatment
- In this study, a complete dosing cycle is 28 days. In each cycle, participants will take dovitinib (TKI258) once a day, at approximately the same time every day for 5 days in a row (starting at Day 1 of Cycle 1). After taking the 5 days, participants will have two days “off” when no study drug capsules and/or tablets are taken. This dosing scheduled is called “5 days on/2 days off”. Participants may continue to receive study drug unless they and/or the study doctor decide to stop study drug dosing.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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last updated: 28-Sep-16 03:28 PM
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