Testing the Use of Nilotinib and Paclitaxel as a Treatment for Patients With Prior Taxane Treatment, A ComboMATCH Treatment Trial
NCT ID: NCT05554341
Last Updated: 2025-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
40 participants
INTERVENTIONAL
2023-07-14
2026-06-30
Brief Summary
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Detailed Description
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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. Collect tissue and provide it to the ComboMATCH registration protocol to assess concordance between the diagnostic tumor mutation profile generated by the designated laboratories, the pre-treatment biopsy mutation profile, and the pre-treatment circulating tumor deoxyribonucleic acid (ctDNA) mutation profile from plasma, as described in ComboMATCH registration protocol. For this treatment substudy, the outcome objective will be to report the proportion of cases providing sufficient tissue for that integrated scientific activity 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) throughout the study. Patients also undergo collection of blood samples and tumor biopsy on study.
After completion of study treatment, patients are followed until disease progression, and for survival for 3 years from registration.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (nilotinib hydrochloride monohydrate, paclitaxel)
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.
Biopsy Procedure
Undergo biopsy
Biospecimen Collection
Undergo collection of blood samples
Computed Tomography
Undergo CT
Magnetic Resonance Imaging
Undergo MRI
Nilotinib Hydrochloride Monohydrate
Given PO
Paclitaxel
Given IV
Interventions
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Biopsy Procedure
Undergo biopsy
Biospecimen Collection
Undergo collection of blood samples
Computed Tomography
Undergo CT
Magnetic Resonance Imaging
Undergo MRI
Nilotinib Hydrochloride Monohydrate
Given PO
Paclitaxel
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient must be \>= 18 years of age
* 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 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 the date of registration on the ComboMATCH registration trial (EAY191)
* 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 0-2
* Patient must not have had platinum-resistant epithelial serous ovarian cancer
* Patients must not have neuropathy \>= grade 2 within 14 days of registration/randomization
* Patient must have documented QT interval with Fridericia's correction (QTcF) of =\< 450 msec within 8 days prior to EAY191-E4 registration. Patients with a QTcF interval of \>= 450 msec at registration or patients with congenital long QT syndrome are not eligible
* 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
* Patients must have progressive disease
* Absolute neutrophil count (ANC) \>= 1,500/mcL
* Platelets \>= 100,000/mcL
* Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) (with the exception of those with Gilbert syndrome, who must have total bilirubin =\< 3 x institutional ULN)
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 institutional upper limit of normal; \< 5.0 x ULN in patients with liver metastases
* Creatinine clearance \> 60 mL/min/1.73 m\^2 for patients with creatinine levels \> 1.5 mg/dL
* Patient must have the ability to swallow medications
* Patient must have completed any prior therapy ≥ 4 weeks or ≥ 5 half-lives of the prior agent (whichever is shorter) prior to enrollment on protocol. Prior definitive radiation should have been completed ≥ 4 weeks prior to enrollment; prior palliative radiation should have been completed ≥ 2 weeks prior to enrollment. Patients must be ≥ 2 weeks since any investigational agent administered as part of a phase 0 study (where a sub-therapeutic dose of drug is administered) and should have recovered to grade 1 or baseline from any toxicities
* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression for ≥ 1 month after treatment of the brain metastases
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Sarah Shin
Role: PRINCIPAL_INVESTIGATOR
ECOG-ACRIN Cancer Research Group
Locations
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University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Kingman Regional Medical Center
Kingman, Arizona, United States
Stanford Cancer Institute Palo Alto
Palo Alto, California, United States
Presbyterian Intercommunity Hospital
Whittier, California, United States
UCHealth University of Colorado Hospital
Aurora, Colorado, United States
UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida, United States
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, United States
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, United States
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, United States
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, United States
Advocate Good Shepherd Hospital
Barrington, Illinois, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States
Illinois CancerCare-Canton
Canton, Illinois, United States
Illinois CancerCare-Carthage
Carthage, Illinois, United States
Centralia Oncology Clinic
Centralia, Illinois, United States
Northwestern University
Chicago, Illinois, United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, United States
Advocate Illinois Masonic Medical Center
Chicago, Illinois, United States
AMG Crystal Lake - Oncology
Crystal Lake, Illinois, United States
Carle at The Riverfront
Danville, Illinois, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Illinois CancerCare-Dixon
Dixon, Illinois, United States
Advocate Good Samaritan Hospital
Downers Grove, Illinois, United States
Carle Physician Group-Effingham
Effingham, Illinois, United States
Crossroads Cancer Center
Effingham, Illinois, United States
Advocate Sherman Hospital
Elgin, Illinois, United States
Illinois CancerCare-Eureka
Eureka, Illinois, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States
Advocate South Suburban Hospital
Hazel Crest, Illinois, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States
AMG Libertyville - Oncology
Libertyville, Illinois, United States
Condell Memorial Hospital
Libertyville, Illinois, United States
Illinois CancerCare-Macomb
Macomb, Illinois, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States
Illinois CancerCare-Pekin
Pekin, Illinois, United States
Illinois CancerCare-Peoria
Peoria, Illinois, United States
Illinois CancerCare-Peru
Peru, Illinois, United States
Illinois CancerCare-Princeton
Princeton, Illinois, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Springfield Clinic
Springfield, Illinois, United States
Springfield Memorial Hospital
Springfield, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Illinois CancerCare - Washington
Washington, Illinois, United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States
Lafayette Family Cancer Center-EMMC
Brewer, Maine, United States
National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, United States
Trinity Health Medical Center - Brighton
Brighton, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, United States
Trinity Health Medical Center - Canton
Canton, Michigan, United States
Chelsea Hospital
Chelsea, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, United States
Cancer Hematology Centers - Flint
Flint, Michigan, United States
Genesee Hematology Oncology PC
Flint, Michigan, United States
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, United States
Henry Ford Saint John Hospital - Macomb Medical
Macomb, Michigan, United States
Huron Gastroenterology PC
Ypsilanti, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, United States
Parkland Health Center - Farmington
Farmington, Missouri, United States
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, United States
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, United States
Community Hospital of Anaconda
Anaconda, Montana, United States
Billings Clinic Cancer Center
Billings, Montana, United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, United States
Benefis Sletten Cancer Institute
Great Falls, Montana, United States
Logan Health Medical Center
Kalispell, Montana, United States
Community Medical Center
Missoula, Montana, United States
OptumCare Cancer Care at Seven Hills
Henderson, Nevada, United States
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, United States
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Mount Sinai Hospital
New York, New York, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States
Sanford Broadway Medical Center
Fargo, North Dakota, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States
Dayton Physician LLC - Englewood
Dayton, Ohio, United States
Kettering Medical Center
Kettering, Ohio, United States
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Providence Saint Vincent Medical Center
Portland, Oregon, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States
M D Anderson Cancer Center
Houston, Texas, United States
Swedish Cancer Institute-Edmonds
Edmonds, Washington, United States
Swedish Cancer Institute-Issaquah
Issaquah, Washington, United States
Valley Medical Center
Renton, Washington, United States
Swedish Medical Center-First Hill
Seattle, Washington, United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, United States
ThedaCare Regional Cancer Center
Appleton, Wisconsin, United States
Aurora Cancer Care-Grafton
Grafton, Wisconsin, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin, United States
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, United States
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, United States
Aurora Medical Center in Summit
Summit, Wisconsin, United States
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, United States
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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NCI-2022-07264
Identifier Type: REGISTRY
Identifier Source: secondary_id
EAY191-E4
Identifier Type: OTHER
Identifier Source: secondary_id
EAY191-E4
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2022-07264
Identifier Type: -
Identifier Source: org_study_id
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