NCT05554341|Active Not RecruitingPhase 2FDA Drug

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

Nilotinib and Paclitaxel in Patients With Prior Taxane-Treated Solid Tumors: A ComboMATCH Treatment Trial

National Cancer Institute (NCI)ClinicalTrials.gov

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3 other identifiers

NCI-2022-07264EAY191-E4U10CA180820

Study Type

interventional

Target

Locations

1 country

Sites

125

Timeline

RegisteredSep 2022

StartedJul 2023

CompletionJun 2026

Brief Summary

This phase II ComboMATCH treatment 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 tumor cells to multiply. This helps slow or stop the proliferation of tumor cells. Paclitaxel is a drug that blocks cell growth by stopping cell division and it may kill tumor cells. Giving nilotinib with paclitaxel may be effective at treating patients with progressive solid cancers that have previously been treated with taxane therapies.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

2mo left

Started Jul 2023

Typical duration for phase_2

Geographic Reach

1 country

125 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3 years study duration

Study Progress95%

Jul 2023Jun 2026

First Submitted

Initial submission to the registry

September 22, 2022

Completed

4 days until next milestone

First Posted

Study publicly available on registry

September 26, 2022

Completed

10 months until next milestone

Study Start

First participant enrolled

July 14, 2023

Completed

3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

May 1, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

September 22, 2022

Last Update Submit

April 30, 2026

Conditions

Metastatic Malignant Solid Neoplasm Refractory Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (4)

Best objective response
Evaluated using Response Evaluation Criteria in Solid Tumors version 1.1. 90% two-sided confidence intervals will be used for reporting estimated rates.
Up to 3 years
Progression free survival
Distribution will be estimated using the method of Kaplan and Meier.
From registration to documented disease progression or death from any cause, assessed up to 3 years
Overall survival
Distribution will be estimated using the method of Kaplan and Meier.
From registration to death from any cause, assessed up to 3 years
Incidence of adverse events
Will be determined using the National Cancer Institute's Common Terminology Criteria for Adverse Events. Exact binomial confidence intervals will be used for adverse event rates.
Up to 3 years

Secondary Outcomes (1)

Concordance of diagnostic tumor mutation profile, pre-treatment tumor biopsy mutation profile, and pre-treatment circulating tumor deoxyribonucleic acid (ctDNA) profile
Up to 3 years

Study Arms (1)

Treatment (nilotinib hydrochloride monohydrate, paclitaxel)

EXPERIMENTAL

Patients receive nilotinib hydrochloride monohydrate PO BID on days 1-28 and paclitaxel 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 CT or MRI throughout the study. Patients also undergo collection of blood samples and tumor biopsy on study.

Procedure: Biopsy ProcedureProcedure: Biospecimen CollectionProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingDrug: Nilotinib Hydrochloride MonohydrateDrug: Paclitaxel