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New treatment option for Malignant Female Reproductive System Neoplasm
Official title Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)
ClinicalTrials.gov ID: NCT06126276
What this study is testing
What is Neratinib Maleate?
Neratinib Maleate is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for malignant female reproductive system neoplasm.
Also referred to as 2-Butenamide, N-(4-((3-chloro-4-(2-pyridinylmethoxy)phenyl)amino)-3-cyano-7-ethoxy-6-quinolinyl)-4-(dimethylamino)-, (2E)-, (2Z)-2-butenedioate (1:1), HKI-272 Maleate.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Patients must have a HER2 amplified solid tumor except breast cancer.
- If IHC is 0 or 1+, patient (pt) is NOT ELIGIBLE regardless of in situ hybridization (ISH)/FISH or next generation sequencing (NGS) status
- If IHC is 3+, pt IS ELIGIBLE regardless of ISH/FISH or NGS status
- If IHC is 2+, ISH/FISH OR NGS must be positive for the patient to be ELIGIBLE. Otherwise, pt is NOT ELIGIBLE
See the full eligibility 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.
- If IHC is 0 or 1+, patient (pt) is NOT ELIGIBLE regardless of in situ hybridization (ISH)/FISH or next generation sequencing (NGS) status
- If IHC is 3+, pt IS ELIGIBLE regardless of ISH/FISH or NGS status
- If IHC is 2+, ISH/FISH OR NGS must be positive for the patient to be ELIGIBLE. Otherwise, pt is NOT ELIGIBLE
- If IHC is unknown and…
- ISH/FISH is positive, independent of NGS results, the patient IS ELIGIBLE
- ISH/FISH is negative and NGS positive with ≥ 7 copies, the patient IS ELIGIBLE
- 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...
- 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...
- 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, antibody drug conjugates (ADC) such as DS8201a or T-DM1 is allowed
- No prior therapy with HER2 targeting tyrosine kinase inhibitors (TKI) such as neratinib or tucatinib
- 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. No HER2 targeting ADCs within 30 days prior to...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Mobile, Alabama, United States
- Anchorage, Alaska, United States
- Encinitas, California, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- San Diego, California, United States
- Aventura, Florida, United States
- Coral Gables, Florida, United States
- Coral Springs, Florida, United States
- Deerfield Beach, Florida, United States
- Miami, Florida, United States
- North Miami, Florida, United States
- Plantation, Florida, United States
- Boise, Idaho, United States
- Caldwell, Idaho, United States
- Coeur d'Alene, Idaho, United States
- Fruitland, Idaho, United States
- Meridian, Idaho, United States
- Nampa, Idaho, United States
+ 133 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Mobile, Alabama, United States; Anchorage, Alaska, United States; Encinitas, California, United States; La Jolla, California, United States; Los Angeles, California, United States and 147 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.