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COMPLETED
NCT02379416
PHASE1

Combination Nilotinib and Paclitaxel in Adults With Relapsed Solid Tumors

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

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.

Official title: Phase I Trial of the Combination of Nilotinib and Paclitaxel in Adults and Pediatric Patients With Refractory Solid Tumors

Key Details

Gender

All

Age Range

12 Years - 120 Years

Study Type

INTERVENTIONAL

Enrollment

47

Start Date

2015-04-13

Completion Date

2026-02-25

Last Updated

2026-04-21

Healthy Volunteers

No

Conditions

Interventions

DRUG

Nilotinib + Paclitaxel

The BCR-Abl kinase inhibitor nilotinib demonstrated greater than additive activity in combination with the anti-tubulin agent paclitaxel in preclinical xenograft models, justifying the clinical evaluation of this combination for its antitumor activity

Locations (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States