New combo aims to outsmart Drug-Resistant cancers

NCT ID NCT05554341

Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 05, 2026 · Updated 2 times

Summary

This phase 2 trial tests whether combining nilotinib (a targeted drug) with paclitaxel (a chemotherapy drug) can help patients whose solid tumors have grown despite prior taxane treatment. About 40 adults with advanced or resistant cancers will receive the combination. The study measures tumor shrinkage, survival, and side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: nilotinib and paclitaxel
What this could lead to: If successful, this combination could offer a new treatment option for patients with solid tumors that have stopped responding to standard taxane chemotherapy.
What could go wrong: This is a small, early-phase trial with only 40 participants, so results may not apply to all patients. The combination may cause side effects or fail to shrink tumors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2023

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

metastatic malignant neoplasm Neoplasm Metastasis refractory malignant neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic malignant solid neoplasm Refractory malignant solid neoplasm

Contacts and locations

Locations

AMG Crystal Lake - Oncology

Crystal Lake, Illinois, 60014, United States
AMG Libertyville - Oncology

Libertyville, Illinois, 60048, United States
Advocate Christ Medical Center

Oak Lawn, Illinois, 60453-2699, United States
Advocate Good Samaritan Hospital

Downers Grove, Illinois, 60515, United States
Advocate Good Shepherd Hospital

Barrington, Illinois, 60010, United States
Advocate Illinois Masonic Medical Center

Chicago, Illinois, 60657, United States
Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068, United States
Advocate Sherman Hospital

Elgin, Illinois, 60123, United States
Advocate South Suburban Hospital

Hazel Crest, Illinois, 60429, United States
Aurora Bay Area Medical Group-Marinette

Marinette, Wisconsin, 54143, United States
Aurora BayCare Medical Center

Green Bay, Wisconsin, 54311, United States
Aurora Cancer Care-Grafton

Grafton, Wisconsin, 53024, United States
Aurora Cancer Care-Milwaukee West

Wauwatosa, Wisconsin, 53226, United States
Aurora Medical Center in Summit

Summit, Wisconsin, 53066, United States
Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States
Aurora Sinai Medical Center

Milwaukee, Wisconsin, 53233, United States
Aurora West Allis Medical Center

West Allis, Wisconsin, 53227, United States
Benefis Sletten Cancer Institute

Great Falls, Montana, 59405, United States
Billings Clinic Cancer Center

Billings, Montana, 59101, United States
Bozeman Health Deaconess Hospital

Bozeman, Montana, 59715, United States
Cancer Care Center of O'Fallon

O'Fallon, Illinois, 62269, United States
Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526, United States
Cancer Hematology Centers - Flint

Flint, Michigan, 48503, United States
Carle Cancer Center

Urbana, Illinois, 61801, United States
Carle Physician Group-Effingham

Effingham, Illinois, 62401, United States
Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938, United States
Carle at The Riverfront

Danville, Illinois, 61832, United States
Centralia Oncology Clinic

Centralia, Illinois, 62801, United States
Chelsea Hospital

Chelsea, Michigan, 48118, United States
Community Hospital of Anaconda

Anaconda, Montana, 59711, United States
Community Medical Center

Missoula, Montana, 59804, United States
Condell Memorial Hospital

Libertyville, Illinois, 60048, United States
Crossroads Cancer Center

Effingham, Illinois, 62401, United States
Dayton Physician LLC - Englewood

Dayton, Ohio, 45415, United States
Decatur Memorial Hospital

Decatur, Illinois, 62526, United States
Genesee Hematology Oncology PC

Flint, Michigan, 48503, United States
Genesys Hurley Cancer Institute

Flint, Michigan, 48503, United States
Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States
Henry Ford Saint John Hospital - Macomb Medical

Macomb, Michigan, 48044, United States
Hurley Medical Center

Flint, Michigan, 48503, United States
Huron Gastroenterology PC

Ypsilanti, Michigan, 48106, United States
Illinois CancerCare - Washington

Washington, Illinois, 61571, United States
Illinois CancerCare-Bloomington

Bloomington, Illinois, 61704, United States
Illinois CancerCare-Canton

Canton, Illinois, 61520, United States
Illinois CancerCare-Carthage

Carthage, Illinois, 62321, United States
Illinois CancerCare-Dixon

Dixon, Illinois, 61021, United States
Illinois CancerCare-Eureka

Eureka, Illinois, 61530, United States
Illinois CancerCare-Galesburg

Galesburg, Illinois, 61401, United States
Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, 61443, United States
Illinois CancerCare-Macomb

Macomb, Illinois, 61455, United States
Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, 61350, United States
Illinois CancerCare-Pekin

Pekin, Illinois, 61554, United States
Illinois CancerCare-Peoria

Peoria, Illinois, 61615, United States
Illinois CancerCare-Peru

Peru, Illinois, 61354, United States
Illinois CancerCare-Princeton

Princeton, Illinois, 61356, United States
John H Stroger Jr Hospital of Cook County

Chicago, Illinois, 60612, United States
Kettering Medical Center

Kettering, Ohio, 45429, United States
Kingman Regional Medical Center

Kingman, Arizona, 86401, United States
Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, 83854, United States
Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, Idaho, 83864, United States
Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, 83814, United States
Lafayette Family Cancer Center-EMMC

Brewer, Maine, 04412, United States
Logan Health Medical Center

Kalispell, Montana, 59901, United States
Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States
Missouri Baptist Sullivan Hospital

Sullivan, Missouri, 63080, United States
Mount Sinai Hospital

New York, New York, 10029, United States
National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital

Yakima, Washington, 98902, United States
Northwestern University

Chicago, Illinois, 60611, United States
Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121, United States
OptumCare Cancer Care at Charleston

Las Vegas, Nevada, 89102, United States
OptumCare Cancer Care at Fort Apache

Las Vegas, Nevada, 89183, United States
Parkland Health Center - Farmington

Farmington, Missouri, 63640, United States
Presbyterian Intercommunity Hospital

Whittier, California, 90602, United States
Providence Portland Medical Center

Portland, Oregon, 97213, United States
Providence Saint Vincent Medical Center

Portland, Oregon, 97225, United States
Roswell Park Cancer Institute

Buffalo, New York, 14263, United States
Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, 83706, United States
Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, 83605, United States
Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, 83687, United States
Saint Alphonsus Cancer Care Center-Ontario

Ontario, Oregon, 97914, United States
Saint Francis Medical Center

Cape Girardeau, Missouri, 63703, United States
Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, 63670, United States
Sanford Bismarck Medical Center

Bismarck, North Dakota, 58501, United States
Sanford Broadway Medical Center

Fargo, North Dakota, 58122, United States
Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, 57104, United States
Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, 56601, United States
Sanford Roger Maris Cancer Center

Fargo, North Dakota, 58122, United States
Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134, United States
Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States
Springfield Clinic

Springfield, Illinois, 62702, United States
Springfield Memorial Hospital

Springfield, Illinois, 62781, United States
Stanford Cancer Institute Palo Alto

Palo Alto, California, 94304, United States
Swedish Cancer Institute-Edmonds

Edmonds, Washington, 98026, United States
Swedish Cancer Institute-Issaquah

Issaquah, Washington, 98029, United States
Swedish Medical Center-First Hill

Seattle, Washington, 98122, United States
ThedaCare Regional Cancer Center

Appleton, Wisconsin, 54911, United States
Toledo Clinic Cancer Centers-Toledo

Toledo, Ohio, 43623, United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, 48114, United States
Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, 48188, United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, 48118, United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, 48197, United States
Trinity Health Medical Center - Brighton

Brighton, Michigan, 48114, United States
Trinity Health Medical Center - Canton

Canton, Michigan, 48188, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, 48106, United States
Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154, United States
UCHealth University of Colorado Hospital

Aurora, Colorado, 80045, United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, 50309, United States
UM Sylvester Comprehensive Cancer Center at Aventura

Aventura, Florida, 33180, United States
UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, 33146, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, 33442, United States
UM Sylvester Comprehensive Cancer Center at Kendall

Miami, Florida, 33176, United States
UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, 33324, United States
UT MD Anderson Cancer Center

Houston, Texas, 77030, United States
University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States
University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136, United States
University of Michigan Health - Sparrow Lansing

Lansing, Michigan, 48912, United States
University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States
University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, 53792, United States
Valley Medical Center

Renton, Washington, 98055, United States
Vince Lombardi Cancer Clinic - Oshkosh

Oshkosh, Wisconsin, 54904, United States
Vince Lombardi Cancer Clinic-Sheboygan

Sheboygan, Wisconsin, 53081, United States
Vince Lombardi Cancer Clinic-Two Rivers

Two Rivers, Wisconsin, 54241, United States

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