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Completed NCT02379416

Combination Nilotinib and Paclitaxel in Adults With Relapsed Solid Tumors

Conditions: Solid Tumors

Sex: All
Ages: 12 Years – 120 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 47
Sponsor: National Cancer Institute (NCI)

Location: National Institutes of Health Clinical Center Bethesda Maryland

Summary

Background: \- Researchers want to find better ways to treat cancer. One drug that treats cancer is paclitaxel. Sometimes proteins block that drug from working. Researchers want to see if another drug, nilotinib, helps paclitaxel work better. Objective: \- To test the safety of nilotinib plus paclitaxel and find out what doses of the drugs can be given safely to people. Eligibility: \- Adults at least 18 years old with advanced cancer that has progressed after receiving standard treatment, or for which no effective therapy exists. Design: * Participants will be screened with tests they usually get in their cancer care: medical history, physical exam, blood and urine tests, heart test, and scans. * Participants will take the two study drugs in 28-day cycles. They will keep a medicine diary. * Nilotinib will be taken by mouth twice every day except day 1 of the first cycle. * Paclitaxel will be given by IV once a week for the first 3 weeks of a cycle. This will usually be done at the clinic. * Most participants will have a weekly study visit every week for cycle 1, then the first 3 weeks of other cycles. They will have: * Physical exam at every visit. * Blood tests multiple times for cycle 1, then the first 3 weeks of other cycles. * Scans every 8 weeks. These may be CT or MRI scans, in a machine that takes pictures. Or they may be ultrasounds, where a wand is pressed on the skin with gel on it. * Around 30 days after stopping the study drugs, participants will be called to discuss any side effects.

Eligibility Criteria

* INCLUSION CRITERIA: * Patients must have histologically confirmed solid tumors that have progressed on standard therapy known to prolong survival or for which no standard treatment options exist. * Age greater than or equal to 12 years. * ECOG performance status less than or equal to 2. * Life expectancy of greater than 3 months * Patients must have normal organ and marrow function as defined below: * Absolute neutrophil count greater than or equal to 1,500/mcL * Platelets greater than or equal to 100,000/mcL * Total bilirubin less than or equal to 1.5 X institutional ULN (with the exception of those with Gilbert syndrome, who must have total bilirubin \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT02379416). StuddyBuddy aggregates publicly available trial information.