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NCT05554341 | Suspended | Metastatic Malignant Solid Neoplasm


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

National Cancer Institute (NCI)

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.

Condition or disease

Metastatic Malignant Solid Neoplasm

Refractory Malignant Solid Neoplasm

Intervention/treatment

Biopsy

Biospecimen Collection

Computed Tomography

Magnetic Resonance Imaging

Nilotinib Hydrochloride Monohydrate

Paclitaxel

Phase

Phase 2

Detailed Description:

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. 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.

Study Type : Interventional
Estimated Enrollment : 40 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nilotinib and Paclitaxel in Patients With Prior Taxane-Treated Solid Tumors: A ComboMATCH Treatment Trial
Actual Study Start Date : July 14, 2023
Estimated Primary Completion Date : July 1, 2025
Estimated Study Completion Date : July 1, 2025
Arm Intervention/treatment

Experimental: 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.

Procedure: Biopsy

Procedure: Biospecimen Collection

Procedure: Computed Tomography

Procedure: Magnetic Resonance Imaging

Drug: Nilotinib Hydrochloride Monohydrate

Drug: Paclitaxel

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Patient must be enrolled on the ComboMATCH registration protocol (EAY191) at the time of registration to the EAY191-E4 study
  • 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

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

Location Details


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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

United States, Alabama

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States, 35233

Not yet recruiting

United States, Arizona

Kingman Regional Medical Center

Kingman, Arizona, United States, 86401

Not yet recruiting

United States, California

Stanford Cancer Institute Palo Alto

Palo Alto, California, United States, 94304

Not yet recruiting

United States, California

Presbyterian Intercommunity Hospital

Whittier, California, United States, 90602

Not yet recruiting

United States, Colorado

UCHealth University of Colorado Hospital

Aurora, Colorado, United States, 80045

Not yet recruiting

United States, Florida

UM Sylvester Comprehensive Cancer Center at Aventura

Aventura, Florida, United States, 33180

Not yet recruiting

United States, Florida

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, United States, 33146

Not yet recruiting

United States, Florida

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States, 33442

Not yet recruiting

United States, Florida

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States, 33136

Not yet recruiting

United States, Florida

UM Sylvester Comprehensive Cancer Center at Kendall

Miami, Florida, United States, 33176

Not yet recruiting

United States, Florida

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, United States, 33324

Not yet recruiting

United States, Idaho

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States, 83706

Not yet recruiting

United States, Idaho

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, United States, 83605

Not yet recruiting

United States, Idaho

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, United States, 83814

Not yet recruiting

United States, Idaho

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, United States, 83687

Not yet recruiting

United States, Idaho

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, United States, 83854

Not yet recruiting

United States, Idaho

Kootenai Cancer Clinic

Sandpoint, Idaho, United States, 83864

Not yet recruiting

United States, Illinois

Advocate Good Shepherd Hospital

Barrington, Illinois, United States, 60010

Not yet recruiting

United States, Illinois

Illinois CancerCare-Bloomington

Bloomington, Illinois, United States, 61704

Not yet recruiting

United States, Illinois

Illinois CancerCare-Canton

Canton, Illinois, United States, 61520

Not yet recruiting

United States, Illinois

Illinois CancerCare-Carthage

Carthage, Illinois, United States, 62321

Not yet recruiting

United States, Illinois

Centralia Oncology Clinic

Centralia, Illinois, United States, 62801

Not yet recruiting

United States, Illinois

Northwestern University

Chicago, Illinois, United States, 60611

Not yet recruiting

United States, Illinois

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, United States, 60612

Not yet recruiting

United States, Illinois

Advocate Illinois Masonic Medical Center

Chicago, Illinois, United States, 60657

Not yet recruiting

United States, Illinois

AMG Crystal Lake - Oncology

Crystal Lake, Illinois, United States, 60014

Not yet recruiting

United States, Illinois

Carle at The Riverfront

Danville, Illinois, United States, 61832

Not yet recruiting

United States, Illinois

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States, 62526

Not yet recruiting

United States, Illinois

Decatur Memorial Hospital

Decatur, Illinois, United States, 62526

Not yet recruiting

United States, Illinois

Illinois CancerCare-Dixon

Dixon, Illinois, United States, 61021

Not yet recruiting

United States, Illinois

Advocate Good Samaritan Hospital

Downers Grove, Illinois, United States, 60515

Not yet recruiting

United States, Illinois

Carle Physician Group-Effingham

Effingham, Illinois, United States, 62401

Not yet recruiting

United States, Illinois

Crossroads Cancer Center

Effingham, Illinois, United States, 62401

Not yet recruiting

United States, Illinois

Advocate Sherman Hospital

Elgin, Illinois, United States, 60123

Not yet recruiting

United States, Illinois

Illinois CancerCare-Eureka

Eureka, Illinois, United States, 61530

Not yet recruiting

United States, Illinois

Illinois CancerCare-Galesburg

Galesburg, Illinois, United States, 61401

Not yet recruiting

United States, Illinois

Advocate South Suburban Hospital

Hazel Crest, Illinois, United States, 60429

Not yet recruiting

United States, Illinois

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, United States, 61443

Not yet recruiting

United States, Illinois

AMG Libertyville - Oncology

Libertyville, Illinois, United States, 60048

Not yet recruiting

United States, Illinois

Condell Memorial Hospital

Libertyville, Illinois, United States, 60048

Not yet recruiting

United States, Illinois

Illinois CancerCare-Macomb

Macomb, Illinois, United States, 61455

Not yet recruiting

United States, Illinois

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States, 61938

Not yet recruiting

United States, Illinois

Cancer Care Center of O'Fallon

O'Fallon, Illinois, United States, 62269

Not yet recruiting

United States, Illinois

Advocate Christ Medical Center

Oak Lawn, Illinois, United States, 60453-2699

Not yet recruiting

United States, Illinois

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States, 61350

Not yet recruiting

United States, Illinois

Advocate Lutheran General Hospital

Park Ridge, Illinois, United States, 60068

Not yet recruiting

United States, Illinois

Illinois CancerCare-Pekin

Pekin, Illinois, United States, 61554

Not yet recruiting

United States, Illinois

Illinois CancerCare-Peoria

Peoria, Illinois, United States, 61615

Not yet recruiting

United States, Illinois

Illinois CancerCare-Peru

Peru, Illinois, United States, 61354

Not yet recruiting

United States, Illinois

Illinois CancerCare-Princeton

Princeton, Illinois, United States, 61356

Not yet recruiting

United States, Illinois

Southern Illinois University School of Medicine

Springfield, Illinois, United States, 62702

Not yet recruiting

United States, Illinois

Springfield Clinic

Springfield, Illinois, United States, 62702

Not yet recruiting

United States, Illinois

Memorial Medical Center

Springfield, Illinois, United States, 62781

Not yet recruiting

United States, Illinois

Carle Cancer Center

Urbana, Illinois, United States, 61801

Not yet recruiting

United States, Illinois

Illinois CancerCare - Washington

Washington, Illinois, United States, 61571

Not yet recruiting

United States, Iowa

Medical Oncology and Hematology Associates-Des Moines

Des Moines, Iowa, United States, 50309

Not yet recruiting

United States, Kentucky

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States, 40536

Not yet recruiting

United States, Louisiana

Ochsner Medical Center Jefferson

New Orleans, Louisiana, United States, 70121

Not yet recruiting

United States, Maine

Lafayette Family Cancer Center-EMMC

Brewer, Maine, United States, 04412

Not yet recruiting

United States, Maryland

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Not yet recruiting

United States, Michigan

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, United States, 48106

Not yet recruiting

United States, Michigan

Saint Joseph Mercy Brighton

Brighton, Michigan, United States, 48114

Not yet recruiting

United States, Michigan

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, United States, 48114

Not yet recruiting

United States, Michigan

Saint Joseph Mercy Canton

Canton, Michigan, United States, 48188

Not yet recruiting

United States, Michigan

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, United States, 48188

Not yet recruiting

United States, Michigan

Saint Joseph Mercy Chelsea

Chelsea, Michigan, United States, 48118

Not yet recruiting

United States, Michigan

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, United States, 48118

Not yet recruiting

United States, Michigan

Genesee Cancer and Blood Disease Treatment Center

Flint, Michigan, United States, 48503

Not yet recruiting

United States, Michigan

Genesee Hematology Oncology PC

Flint, Michigan, United States, 48503

Not yet recruiting

United States, Michigan

Genesys Hurley Cancer Institute

Flint, Michigan, United States, 48503

Not yet recruiting

United States, Michigan

Hurley Medical Center

Flint, Michigan, United States, 48503

Not yet recruiting

United States, Michigan

Sparrow Hospital

Lansing, Michigan, United States, 48912

Not yet recruiting

United States, Michigan

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, United States, 48154

Not yet recruiting

United States, Michigan

Great Lakes Cancer Management Specialists-Macomb Medical Campus

Macomb, Michigan, United States, 48044

Not yet recruiting

United States, Michigan

Huron Gastroenterology PC

Ypsilanti, Michigan, United States, 48106

Not yet recruiting

United States, Michigan

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, United States, 48197

Not yet recruiting

United States, Minnesota

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, United States, 56601

Not yet recruiting

United States, Missouri

Saint Francis Medical Center

Cape Girardeau, Missouri, United States, 63703

Not yet recruiting

United States, Missouri

Parkland Health Center - Farmington

Farmington, Missouri, United States, 63640

Not yet recruiting

United States, Missouri

Missouri Baptist Medical Center

Saint Louis, Missouri, United States, 63131

Not yet recruiting

United States, Missouri

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, United States, 63670

Not yet recruiting

United States, Missouri

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, United States, 63080

Not yet recruiting

United States, Missouri

BJC Outpatient Center at Sunset Hills

Sunset Hills, Missouri, United States, 63127

Not yet recruiting

United States, Montana

Community Hospital of Anaconda

Anaconda, Montana, United States, 59711

Not yet recruiting

United States, Montana

Billings Clinic Cancer Center

Billings, Montana, United States, 59101

Not yet recruiting

United States, Montana

Bozeman Deaconess Hospital

Bozeman, Montana, United States, 59715

Not yet recruiting

United States, Montana

Benefis Healthcare- Sletten Cancer Institute

Great Falls, Montana, United States, 59405

Not yet recruiting

United States, Montana

Kalispell Regional Medical Center

Kalispell, Montana, United States, 59901

Not yet recruiting

United States, Montana

Community Medical Hospital

Missoula, Montana, United States, 59804

Not yet recruiting

United States, Nevada

OptumCare Cancer Care at Seven Hills

Henderson, Nevada, United States, 89052

Not yet recruiting

United States, Nevada

OptumCare Cancer Care at Charleston

Las Vegas, Nevada, United States, 89102

Not yet recruiting

United States, Nevada

OptumCare Cancer Care at Fort Apache

Las Vegas, Nevada, United States, 89148

Not yet recruiting

United States, New York

Roswell Park Cancer Institute

Buffalo, New York, United States, 14263

Not yet recruiting

United States, New York

Mount Sinai Hospital

New York, New York, United States, 10029

Not yet recruiting

United States, North Dakota

Sanford Bismarck Medical Center

Bismarck, North Dakota, United States, 58501

Not yet recruiting

United States, North Dakota

Sanford Broadway Medical Center

Fargo, North Dakota, United States, 58122

Not yet recruiting

United States, North Dakota

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States, 58122

Not yet recruiting

United States, Ohio

Dayton Physician LLC-Miami Valley Hospital North

Dayton, Ohio, United States, 45415

Not yet recruiting

United States, Ohio

Kettering Medical Center

Kettering, Ohio, United States, 45429

Not yet recruiting

United States, Ohio

Toledo Clinic Cancer Centers-Toledo

Toledo, Ohio, United States, 43623

Not yet recruiting

United States, Oklahoma

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States, 73104

Not yet recruiting

United States, Oregon

Saint Alphonsus Medical Center-Ontario

Ontario, Oregon, United States, 97914

Not yet recruiting

United States, Oregon

Providence Portland Medical Center

Portland, Oregon, United States, 97213

Not yet recruiting

United States, Oregon

Providence Saint Vincent Medical Center

Portland, Oregon, United States, 97225

Not yet recruiting

United States, South Dakota

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, United States, 57104

Not yet recruiting

United States, South Dakota

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, United States, 57117-5134

Not yet recruiting

United States, Texas

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Not yet recruiting

United States, Washington

Swedish Cancer Institute-Edmonds

Edmonds, Washington, United States, 98026

Not yet recruiting

United States, Washington

Swedish Cancer Institute-Issaquah

Issaquah, Washington, United States, 98029

Not yet recruiting

United States, Washington

Valley Medical Center

Renton, Washington, United States, 98055

Not yet recruiting

United States, Washington

Swedish Medical Center-First Hill

Seattle, Washington, United States, 98122

Not yet recruiting

United States, Washington

North Star Lodge Cancer Center at Yakima Valley Memorial Hospital

Yakima, Washington, United States, 98902

Not yet recruiting

United States, Wisconsin

ThedaCare Regional Cancer Center

Appleton, Wisconsin, United States, 54911

Not yet recruiting

United States, Wisconsin

Aurora Cancer Care-Grafton

Grafton, Wisconsin, United States, 53024

Not yet recruiting

United States, Wisconsin

Aurora BayCare Medical Center

Green Bay, Wisconsin, United States, 54311

Not yet recruiting

United States, Wisconsin

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States, 54601

Not yet recruiting

United States, Wisconsin

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States, 53792

Not yet recruiting

United States, Wisconsin

Aurora Bay Area Medical Group-Marinette

Marinette, Wisconsin, United States, 54143

Not yet recruiting

United States, Wisconsin

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, United States, 53215

Not yet recruiting

United States, Wisconsin

Aurora Sinai Medical Center

Milwaukee, Wisconsin, United States, 53233

Not yet recruiting

United States, Wisconsin

Vince Lombardi Cancer Clinic - Oshkosh

Oshkosh, Wisconsin, United States, 54904

Not yet recruiting

United States, Wisconsin

Vince Lombardi Cancer Clinic-Sheboygan

Sheboygan, Wisconsin, United States, 53081

Not yet recruiting

United States, Wisconsin

Aurora Medical Center in Summit

Summit, Wisconsin, United States, 53066

Not yet recruiting

United States, Wisconsin

Vince Lombardi Cancer Clinic-Two Rivers

Two Rivers, Wisconsin, United States, 54241

Not yet recruiting

United States, Wisconsin

Aurora Cancer Care-Milwaukee West

Wauwatosa, Wisconsin, United States, 53226

Not yet recruiting

United States, Wisconsin

Aurora West Allis Medical Center

West Allis, Wisconsin, United States, 53227

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