Malignant Solid Neoplasm Clinical Trial
Official title:
A Randomized Trial of Neratinib, A Pan-ERBB Inhibitor, Alone or in Combination With Palbociclib, a CDK4/6 Inhibitor, in Patients With HER2+ Gynecologic Cancers and Other Solid Tumors: A ComboMATCH Treatment Trial
Verified date | May 2024 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This phase II ComboMATCH treatment trial compares the effect of neratinib to the combination of neratinib and palbociclib in treating patients with HER2 positive solid tumors. Neratinib and palbociclib are in a class of medications called kinase inhibitors. They work by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of tumor cells. Giving neratinib and palbociclib in combination may shrink or stabilize cancers that over-express a specific biomarker called HER2.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | April 30, 2025 |
Est. primary completion date | April 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patient must have enrolled onto EAY191 and must have been given a treatment assignment to ComboMATCH to EAY191-N5 based on the presence of an actionable mutation as defined in EAY191 - Patients must have a HER2 amplified solid tumor except breast cancer. Patient's cancer must have HER2 amplification as defined with = 7 copies by next generation sequencing (NGS) testing - Patients must have recurrent or persistent disease - No known evidence of RB1 loss or deletion including copy number loss or deleterious mutation - Patients must have disease that can be safely biopsied and agree to a pre-treatment biopsy or, if disease cannot be safely biopsied, have archival tissue available from within 12 months prior to the date of registration on the ComboMATCH Registration Trial (EAY191) - Patients must have measurable disease based on RECIST 1.1. A second measurable lesion outside of the biopsiable lesion is required - 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 3 months or more and patient is not on steroids and is asymptomatic - No known leptomeningeal disease - Patients may have received up to 5 prior lines of systemic therapy - Prior therapy with trastuzumab or pertuzumab, either alone or in combination, is allowed - One prior line of anti-HER2 therapy is allowed except tyrosine kinase inhibitors (TKI) such as neratinib or tucatinib or antibody drug conjugates (ADC) such as DS8201a or T-DM1 - No prior therapy with CDK4/6 inhibition - No cancer directed therapy within 3 weeks prior to registration. For oral therapy, the washout can be reduced to greater than or equal to 5 half lives of the drug - Age = 18 - Eastern Cooperative Oncology Group (ECOG) Performance Status of = 2 - Not pregnant and not nursing - Absolute neutrophil count (ANC) = 1,500 cells/mm^3 - Platelets = 100,000 cells/mm^3 - Hemoglobin = 9 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin (Hgb) = 9 g/dl is acceptable) - Creatinine clearance (CrCL) of = 30 mL/min by the Cockcroft-Gault formula - Total bilirubin level = 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level = 3 x institutional ULN may be enrolled) - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 3 x institutional upper limit of normal (ULN) - Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better - No active infection requiring parenteral antibiotics - No current evidence of intra-abdominal abscess, abdominal/pelvic fistula (not diverted), gastrointestinal perforation, gastrointestinal (GI) obstruction, and/or need for drainage nasogastric or gastrostomy tube - No current evidence of malabsorption or chronic diarrhea or any other significant gastro-intestinal disease (e.g gastrectomy, ileal bypass, Crohn's disease, gastroparesis), associated with moderate to severe diarrhea (grade 2 or more) or inability to tolerate oral therapy - No lung disease causing dyspnea at rest - No interstitial lung disease with ongoing signs and symptoms at the time of registration - No history of allergic reaction to the study agents, compound of similar chemical or biologic composition of the study agents or any of their excipients |
Country | Name | City | State |
---|---|---|---|
United States | Community Hospital of Anaconda | Anaconda | Montana |
United States | Mission Cancer and Blood - Ankeny | Ankeny | Iowa |
United States | Saint Joseph Mercy Hospital | Ann Arbor | Michigan |
United States | Saint Alphonsus Cancer Care Center-Boise | Boise | Idaho |
United States | Bozeman Deaconess Hospital | Bozeman | Montana |
United States | Lafayette Family Cancer Center-EMMC | Brewer | Maine |
United States | Trinity Health IHA Medical Group Hematology Oncology - Brighton | Brighton | Michigan |
United States | Saint Alphonsus Cancer Care Center-Caldwell | Caldwell | Idaho |
United States | Trinity Health IHA Medical Group Hematology Oncology - Canton | Canton | Michigan |
United States | Saint Francis Medical Center | Cape Girardeau | Missouri |
United States | Miami Valley Hospital South | Centerville | Ohio |
United States | Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital | Chelsea | Michigan |
United States | John H Stroger Jr Hospital of Cook County | Chicago | Illinois |
United States | Kootenai Health - Coeur d'Alene | Coeur d'Alene | Idaho |
United States | Dayton Blood and Cancer Center | Dayton | Ohio |
United States | Miami Valley Hospital | Dayton | Ohio |
United States | Miami Valley Hospital North | Dayton | Ohio |
United States | Beaumont Hospital - Dearborn | Dearborn | Michigan |
United States | Cancer Care Specialists of Illinois - Decatur | Decatur | Illinois |
United States | Decatur Memorial Hospital | Decatur | Illinois |
United States | Medical Oncology and Hematology Associates-Des Moines | Des Moines | Iowa |
United States | Crossroads Cancer Center | Effingham | Illinois |
United States | Beaumont Hospital - Farmington Hills | Farmington Hills | Michigan |
United States | Genesee Cancer and Blood Disease Treatment Center | 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 | Atrium Medical Center-Middletown Regional Hospital | Franklin | Ohio |
United States | Benefis Healthcare- Sletten Cancer Institute | Great Falls | Montana |
United States | Miami Valley Cancer Care and Infusion | Greenville | Ohio |
United States | M D Anderson Cancer Center | Houston | Texas |
United States | Gundersen Lutheran Medical Center | La Crosse | Wisconsin |
United States | University of Michigan Health - Sparrow Lansing | Lansing | Michigan |
United States | Trinity Health Saint Mary Mercy Livonia Hospital | Livonia | Michigan |
United States | Community Medical Hospital | Missoula | Montana |
United States | Saint Alphonsus Cancer Care Center-Nampa | Nampa | Idaho |
United States | Saint Alphonsus Medical Center-Ontario | Ontario | Oregon |
United States | Kootenai Clinic Cancer Services - Post Falls | Post Falls | Idaho |
United States | William Beaumont Hospital-Royal Oak | Royal Oak | Michigan |
United States | Kootenai Cancer Clinic | Sandpoint | Idaho |
United States | Memorial Medical Center | Springfield | Illinois |
United States | Southern Illinois University School of Medicine | Springfield | Illinois |
United States | Springfield Clinic | Springfield | Illinois |
United States | Upper Valley Medical Center | Troy | Ohio |
United States | William Beaumont Hospital - Troy | Troy | Michigan |
United States | Marshfield Medical Center - Weston | Weston | Wisconsin |
United States | Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus | Ypsilanti | Michigan |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression free survival | The stratified log-rank statistic will be used to draw inferences about the relative activity of the two regimens. Characterized by medians and Kaplan-Meier (KM) curves. | From study entry to time of progression or death, whichever occurs first, or date of last contact if neither progression nor death has occurred, assessed up to 2 years | |
Secondary | Overall survival | The impact of treatment on the hazard of death can be investigated with time dependent covariates. | Up to 2 years |
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