Testing the Use of Nilotinib and Paclitaxel as a Treatment for Patients With Prior Taxane Treatment, A ComboMATCH Treatment Trial

• Status: Not yet recruiting
• Trial end date: 2025-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

Inclusion Criteria:

• Patient must fulfill all eligibility criteria outlined and be enrolled on the ComboMATCH registration protocol (EAY191) at the time of registration to the EAY191-E4 study. This includes submission of next generation sequencing (NGS) data from one of the MATCH designated laboratories for all potential participants prior to treatment protocol assignment. Copy number and allele frequency cutoffs as per the ComboMATCH registration protocol

• Patient must have disease that can be safely biopsied and agree to a pre-treatment biopsy or have archival tissue available from within 12 months prior to EAY191-E4 registration

• NOTE: The current actionable mutation of interest (aMOI)/actionable alteration list for this treatment trial can be found on the Cancer Trials Support Unit (CTSU) website

• NOTE: Novel/dynamic aMOI can be submitted for review per the process described in the ComboMATCH registration protocol

• Patient must be willing to provide blood samples for research purposes

• Patient must have had at least one prior line of therapy in the metastatic setting

• Patient must have previously undergone taxane therapy (in the metastatic setting)

• Patients who previously responded to prior taxane therapy must have received their last dose of taxane therapy within 6 months prior to EAY191-E4 registration and have had no other intervening treatment prior to EAY191-E4 registration

• Patients who did not respond to prior taxane therapy are eligible regardless of the time elapsed since the prior taxane therapy or any other intervening therapies

• Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

• Patient must have documented QT interval with Fridericia's correction (QTcF) of =< 450 msec within 8 days prior to EAY191-E4 registration if they have a history of corrected QT-interval (QTc) prolongation, history of arrythmias, or are receiving medications that prolong QTc. Patients with congenital long QT syndrome are not eligible

• Patients must have progressive disease

Exclusion Criteria:

• Patient must not have any of the following mutations (as determined by the ComboMATCH registration protocol), which are known to confer sensitivity or resistance to nilotinib monotherapy:

• KIT: W557R, V559D, V559A, L576P, and K642E

• PDGFR-alpha: D842V

• Patient must not have had platinum-resistant epithelial serous ovarian cancer

• Patient must not have peripheral neuropathy > grade 1

• Patient must not have sensory/motor neuropathy >= grade 2

• Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.

• All patients of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy.

• A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)

• Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study and for at least 3 months after the last dose of study drug