Combination Nilotinib and Paclitaxel in Adults With Relapsed Solid Tumors

Completed · Phase 1

Conditions studied: Solid Tumors

In brief

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.

Key facts

Study ID

NCT02379416

Run by

National Cancer Institute (NCI)

People needed

47

Starts

2015-04-13

Expected to finish

2026-02-25

Last updated by the study team

2026-08-07

Who can join

Age: 12 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• QTcF interval of less than 450 msec at study entry; congenital long QT syndrome
• Sensory/motor neuropathy less than or equal to Grade 2
• Patients who are receiving any other investigational agents.
• Patients with active brain metastases or carcinomatous meningitis are excluded from this clinical trial. Patients with treated brain metastases, whose brain metastatic disease has remained stable for less than or equal to 4 weeks without requiring steroid and anti-seizure medication are eligible to participate.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to study drugs.
• Uncontrolled intercurrent illness including, but not limited to, serious untreated infection, symptomatic respiratory failure/congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant women are excluded from this study because nilotinib and paclitaxel have been assigned to pregnancy category D by the FDA. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the study drugs, breastfeeding should be discontinued prior to the first dose of study drug and women should refrain from nursing throughout the treatment period and for 3 months following the last dose of study drug.
• HIV-positive patients on combination antiretroviral therapy are ineligible because of possible PK interactions with study drugs.
• Both men and women of all races and ethnic groups are eligible for this trial.

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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