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Last Updated: June 25, 2021

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CLINICAL TRIALS PROFILE FOR NERLYNX

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All Clinical Trials for Nerlynx

Trial ID Title Status Sponsor Phase Start Date Summary
NCT03289039 A Phase 2 Study of Neratinib With or Without Fulvestrant in HER2-Positive, ER-Positive Metastatic Breast Cancer Not yet recruiting Puma Biotechnology, Inc. Phase 2 2017-09-30 This research study is studying a drug called Neratinib with and without Fulvestrant as possible treatments for HER2-positive breast cancer . The interventions involved in this study are: - Neratinib and Fulvestrant - Neratinib alone
NCT03289039 A Phase 2 Study of Neratinib With or Without Fulvestrant in HER2-Positive, ER-Positive Metastatic Breast Cancer Not yet recruiting Dana-Farber Cancer Institute Phase 2 2017-09-30 This research study is studying a drug called Neratinib with and without Fulvestrant as possible treatments for HER2-positive breast cancer . The interventions involved in this study are: - Neratinib and Fulvestrant - Neratinib alone
NCT03457896 Study of Neratinib +Trastuzumab or Neratinib + Cetuximab in Patients With KRAS/NRAS/BRAF/PIK3CA Wild-Type Metastatic Colorectal Cancer by HER2 Status Recruiting Puma Biotechnology, Inc. Phase 2 2018-05-18 This is a phase II trial to examine the efficacy of neratinib plus trastuzumab or neratinib plus cetuximab in patients with "quadruple wild-type" (all RAS/NRAS/BRAF/PIK3CA wild-type), metastatic colorectal cancer based on HER2 status (amplified, non-amplified [wild-type] or mutated). Patients must have confirmed quadruple wild-type (WT) genotype, via NSABP MPR-1 or from colonic biopsy or a metastatic biopsy taken prior to treatment, and known HER2 status.
NCT03457896 Study of Neratinib +Trastuzumab or Neratinib + Cetuximab in Patients With KRAS/NRAS/BRAF/PIK3CA Wild-Type Metastatic Colorectal Cancer by HER2 Status Recruiting NSABP Foundation Inc Phase 2 2018-05-18 This is a phase II trial to examine the efficacy of neratinib plus trastuzumab or neratinib plus cetuximab in patients with "quadruple wild-type" (all RAS/NRAS/BRAF/PIK3CA wild-type), metastatic colorectal cancer based on HER2 status (amplified, non-amplified [wild-type] or mutated). Patients must have confirmed quadruple wild-type (WT) genotype, via NSABP MPR-1 or from colonic biopsy or a metastatic biopsy taken prior to treatment, and known HER2 status.
NCT03919292 Neratinib + Valproate in Advanced Solid Tumors, w/Expansion Cohort in Ras-Mutated Ca Not yet recruiting Puma Biotechnology, Inc. Phase 1/Phase 2 2019-04-30 To determine the recommended phase 2 dose (RP2D) of the combination of neratinib and sodium valproate when given to patients with advanced solid tumors.
NCT03919292 Neratinib + Valproate in Advanced Solid Tumors, w/Expansion Cohort in Ras-Mutated Ca Not yet recruiting Virginia Commonwealth University Phase 1/Phase 2 2019-04-30 To determine the recommended phase 2 dose (RP2D) of the combination of neratinib and sodium valproate when given to patients with advanced solid tumors.
NCT04366713 A Study to Characterize Colon Pathology in Patients With HER2 Amplified Breast Cancer Treated With Neratinib Not yet recruiting Puma Biotechnology, Inc. Phase 2 2020-06-30 This study will investigate colon pathology in patients with HER2-positive breast cancer treated with neratinib. Colonoscopy will be performed after eligibility has been confirmed, prior to administration of the first dose of neratinib, and after 28 days of neratinib treatment.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Nerlynx

Condition Name

Condition Name for Nerlynx
Intervention Trials
Breast Cancer 2
Metastatic Prostate Adenocarcinoma 1
Metastatic Colorectal Cancer 1
HER2-positive Breast Cancer 1
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Condition MeSH

Condition MeSH for Nerlynx
Intervention Trials
Breast Neoplasms 3
Prostatic Neoplasms 1
Adenocarcinoma 1
Neoplasms 1
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Clinical Trial Locations for Nerlynx

Trials by Country

Trials by Country for Nerlynx
Location Trials
United States 8
Portugal 1
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Trials by US State

Trials by US State for Nerlynx
Location Trials
Massachusetts 2
Virginia 1
Tennessee 1
Michigan 1
Illinois 1
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Clinical Trial Progress for Nerlynx

Clinical Trial Phase

Clinical Trial Phase for Nerlynx
Clinical Trial Phase Trials
Phase 2 5
Phase 1/Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Nerlynx
Clinical Trial Phase Trials
Not yet recruiting 5
Recruiting 1
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Clinical Trial Sponsors for Nerlynx

Sponsor Name

Sponsor Name for Nerlynx
Sponsor Trials
Puma Biotechnology, Inc. 6
Dana-Farber Cancer Institute 2
University of Rochester 1
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Sponsor Type

Sponsor Type for Nerlynx
Sponsor Trials
Other 6
Industry 6
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