PRIMARY OBJECTIVE:~I. To evaluate the proportion of patients with taxane-refractory advanced malignancies who have objective responses (OR) to treatment with nilotinib hydrochloride monohydrate (nilotinib) and paclitaxel.~SECONDARY OBJECTIVE:~I. To assess concordance between the diagnostic tumor mutation profile generated by the designated laboratories (DL), the pre-treatment biopsy mutation profile, and the pre-treatment circulating tumor deoxyribonucleic acid (ctDNA) mutation profile from plasma, as described in the ComboMATCH registration protocol.~EXPLORATORY OBJECTIVES:~I. To evaluate progression free survival (PFS) at 6 months on study agents. II. To identify genomic and transcriptomic determinants of response and resistance in tumor biopsy specimens and cell-free deoxyribonucleic acid (DNA).~OUTLINE:~Patients receive nilotinib hydrochloride monohydrate orally (PO) twice daily (BID) on days 1-28 and paclitaxel intravenously (IV) over 1 hour on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) or magnetic resonance imaging (MRI) during screening, on study, and during follow up. Patients also undergo collection of blood samples and tumor biopsy prior to starting treatment.~After completion of study treatment, patients are followed until disease progression, and for survival for 3 years from registration.
This phase II trial evaluates nilotinib with paclitaxel for the treatment of patients with solid cancers that are growing, spreading, or getting worse (progressive) and that have previously been treated with taxane therapies. Nilotinib is in a class of medications called kinase inhibitors. It works by binding to and blocking the action of a protein called ABL, which signals cancer cells to multiply. This helps slow or stop the proliferation of cancer cells. Paclitaxel is a drug that blocks cell growth by stopping cell division and it may kill cancer cells. Giving nilotinib with paclitaxel may be effective at treating patients with progressive solid cancers that have previously been treated with taxane therapies.