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SUSPENDED
NCT05554380
PHASE2

Study of Chemotherapy Plus Ipatasertib for People With Solid Tumors With PTEN/AKT Mutations, A ComboMATCH Treatment Trial

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

This phase II ComboMATCH treatment trial tests the usual treatment of chemotherapy (paclitaxel) plus ipatasertib in patients with solid tumor cancers that that cannot be removed by surgery (unresectable), has spread to nearby tissue or lymph nodes (locally advanced) or from where it first started (primary site) to other places in the body (metastatic), and has PTEN and AKT genetic changes. Chemotherapy drugs, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Targeted therapy, such as Ipatasertib, may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The addition of ipatasertib to paclitaxel in solid tumors with PTEN and AKT genetic changes could increase the percentage of tumors that shrink as well as lengthen the time that the tumors remain stable (without progression). Researchers hope to learn if paclitaxel plus ipatasertib will shrink this type of cancer or stop its growth.

Official title: Phase 2 Study of Paclitaxel (NSC #673089) + Ipatasertib (NSC #781451) in Taxane-Refractory Participants With PTEN/AKT-Altered Advanced Non-Breast Solid Tumors: A ComboMATCH Treatment Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

33

Start Date

2023-09-22

Completion Date

2026-08-31

Last Updated

2026-05-04

Healthy Volunteers

No

Interventions

PROCEDURE

Biopsy Procedure

Undergo tumor biopsy

PROCEDURE

Biospecimen Collection

Undergo blood collection

PROCEDURE

Computed Tomography

Undergo CT scan

DRUG

Ipatasertib

Given PO

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Paclitaxel

Given IV

Locations (209)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, United States

Alaska Women's Cancer Care

Anchorage, Alaska, United States

Kingman Regional Medical Center

Kingman, Arizona, United States

PCR Oncology

Arroyo Grande, California, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

The Angeles Clinic and Research Institute - West Los Angeles Office

Los Angeles, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Saint Joseph Hospital - Orange

Orange, California, United States

Stanford Cancer Institute Palo Alto

Palo Alto, California, United States

Saint John's Cancer Institute

Santa Monica, California, 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

Mayo Clinic in Florida

Jacksonville, 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 Luke's Cancer Institute - 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 Luke's Cancer Institute - Fruitland

Fruitland, Idaho, United States

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, United States

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, United States

Saint Luke's Cancer Institute - 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

Saint Luke's Cancer Institute - Twin Falls

Twin Falls, Idaho, United States

Advocate Good Shepherd Hospital

Barrington, Illinois, United States

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, United States

University of Chicago Comprehensive Cancer Center

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

Advocate Good Samaritan Hospital

Downers Grove, Illinois, United States

Carle Physician Group-Effingham

Effingham, Illinois, United States

Advocate Sherman Hospital

Elgin, Illinois, United States

Advocate South Suburban Hospital

Hazel Crest, Illinois, United States

AMG Libertyville - Oncology

Libertyville, Illinois, United States

Condell Memorial Hospital

Libertyville, Illinois, United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, United States

Advocate Christ Medical Center

Oak Lawn, Illinois, United States

University of Chicago Medicine-Orland Park

Orland Park, Illinois, United States

Advocate Lutheran General Hospital

Park Ridge, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, United States

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, United States

Mercy Medical Center - Des Moines

Des Moines, Iowa, United States

UI Health Care Mission Cancer and Blood - Waukee Clinic

Waukee, Iowa, United States

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States

Harold Alfond Center for Cancer Care

Augusta, Maine, United States

Lafayette Family Cancer Center-EMMC

Brewer, Maine, United States

MaineHealth Maine Medical Center- Scarborough

Scarborough, Maine, United States

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, United States

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

UPMC Western Maryland

Cumberland, Maryland, United States

Tufts Medical Center

Boston, Massachusetts, 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

Corewell Health Dearborn Hospital

Dearborn, Michigan, United States

Corewell Health Farmington Hills Hospital

Farmington Hills, 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

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, United States

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, United States

MyMichigan Medical Center Saginaw

Saginaw, Michigan, United States

Oncology Hematology Associates of Saginaw Valley PC

Saginaw, Michigan, United States

MyMichigan Medical Center Tawas

Tawas City, Michigan, United States

Corewell Health Beaumont Troy Hospital

Troy, Michigan, United States

Saint Mary's Oncology/Hematology Associates of West Branch

West Branch, 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

Mercy Hospital

Coon Rapids, Minnesota, United States

Essentia Health - Deer River Clinic

Deer River, Minnesota, United States

Essentia Health Cancer Center

Duluth, Minnesota, United States

Fairview Southdale Hospital

Edina, Minnesota, United States

Essentia Health Hibbing Clinic

Hibbing, Minnesota, United States

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States

Regions Hospital

Saint Paul, Minnesota, United States

United Hospital

Saint Paul, Minnesota, United States

Essentia Health Sandstone

Sandstone, Minnesota, United States

Essentia Health Virginia Clinic

Virginia, Minnesota, 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 Charleston

Las Vegas, Nevada, United States

OptumCare Cancer Care at Fort Apache

Las Vegas, Nevada, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Mount Sinai Hospital

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, 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

UH Seidman Cancer Center at UH Avon Health Center

Avon, Ohio, United States

UHHS-Chagrin Highlands Medical Center

Beachwood, Ohio, United States

Strecker Cancer Center-Belpre

Belpre, Ohio, United States

Aultman Health Foundation

Canton, Ohio, United States

Adena Regional Medical Center

Chillicothe, Ohio, United States

Case Western Reserve University

Cleveland, Ohio, United States

Mount Carmel East Hospital

Columbus, Ohio, United States

Columbus Oncology and Hematology Associates Inc

Columbus, Ohio, United States

Riverside Methodist Hospital

Columbus, Ohio, United States

Grant Medical Center

Columbus, Ohio, United States

The Mark H Zangmeister Center

Columbus, Ohio, United States

Doctors Hospital

Columbus, Ohio, United States

Dayton Physician LLC - Englewood

Dayton, Ohio, United States

Delaware Health Center-Grady Cancer Center

Delaware, Ohio, United States

Grady Memorial Hospital

Delaware, Ohio, United States

Columbus Oncology and Hematology Associates

Dublin, Ohio, United States

Dublin Methodist Hospital

Dublin, Ohio, United States

Kettering Medical Center

Kettering, Ohio, United States

Fairfield Medical Center

Lancaster, Ohio, United States

OhioHealth Mansfield Hospital

Mansfield, Ohio, United States

OhioHealth Marion General Hospital

Marion, Ohio, United States

Memorial Hospital

Marysville, Ohio, United States

UH Seidman Cancer Center at Lake Health Mentor Campus

Mentor, Ohio, United States

Knox Community Hospital

Mount Vernon, Ohio, United States

Licking Memorial Hospital

Newark, Ohio, United States

Mercy Health - Perrysburg Hospital

Perrysburg, Ohio, United States

Southern Ohio Medical Center

Portsmouth, Ohio, United States

Springfield Regional Cancer Center

Springfield, Ohio, United States

Springfield Regional Medical Center

Springfield, Ohio, United States

Mercy Health - Saint Anne Hospital

Toledo, Ohio, United States

Saint Ann's Hospital

Westerville, Ohio, United States

OhioHealth Westerville Medical Campus/Westerville Cancer Center

Westerville, Ohio, United States

Genesis Healthcare System Cancer Care Center

Zanesville, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Providence Newberg Medical Center

Newberg, Oregon, United States

Saint Alphonsus Cancer Care Center-Ontario

Ontario, Oregon, United States

Providence Willamette Falls Medical Center

Oregon City, Oregon, United States

Providence Portland Medical Center

Portland, Oregon, United States

Providence Saint Vincent Medical Center

Portland, Oregon, United States

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, United States

UPMC Altoona

Altoona, Pennsylvania, United States

Lehigh Valley Hospital - Muhlenberg

Bethlehem, Pennsylvania, United States

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, United States

Pocono Medical Center

East Stroudsburg, Pennsylvania, United States

UPMC Hillman Cancer Center Erie

Erie, Pennsylvania, United States

UPMC Cancer Centers - Arnold Palmer Pavilion

Greensburg, Pennsylvania, United States

Lehigh Valley Hospital-Hazleton

Hazleton, Pennsylvania, United States

UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

Mechanicsburg, Pennsylvania, United States

Riddle Memorial Hospital

Media, Pennsylvania, United States

UPMC Hillman Cancer Center - Monroeville

Monroeville, Pennsylvania, United States

Paoli Memorial Hospital

Paoli, Pennsylvania, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

UPMC-Magee Womens Hospital

Pittsburgh, Pennsylvania, United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

UPMC-Passavant Hospital

Pittsburgh, Pennsylvania, United States

Lankenau Medical Center

Wynnewood, Pennsylvania, United States

Women and Infants Hospital

Providence, Rhode Island, United States

Rapid City Regional Hospital

Rapid City, South Dakota, 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

University of Virginia Cancer Center

Charlottesville, Virginia, United States

Inova Schar Cancer Institute

Fairfax, Virginia, United States

Inova Fairfax Hospital

Falls Church, Virginia, United States

Virginia Cancer Institute

Richmond, Virginia, United States

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, United States

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, United States

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, United States

VCU Community Memorial Health Center

South Hill, Virginia, 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

Duluth Clinic Ashland

Ashland, Wisconsin, United States

Aurora Cancer Care-Southern Lakes VLCC

Burlington, Wisconsin, United States

Aurora Saint Luke's South Shore

Cudahy, Wisconsin, United States

Aurora Health Care Germantown Health Center

Germantown, Wisconsin, United States

Aurora Cancer Care-Grafton

Grafton, Wisconsin, United States

Aurora BayCare Medical Center

Green Bay, Wisconsin, United States

Aurora Cancer Care-Kenosha South

Kenosha, Wisconsin, United States

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Madison, 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 Cancer Care-Milwaukee

Milwaukee, 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

Aurora Cancer Care-Racine

Racine, 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

Puerto Rico Hematology Oncology Group

Bayamón, Puerto Rico

Centro Comprensivo de Cancer de UPR

San Juan, Puerto Rico