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Showing 1–24 of 64 matching trials from the live ClinicalTrials.gov search.
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Completed Phase 1 Interventional Accepts healthy volunteers

Study Evaluating HKI-272 Administered to Healthy Subjects

NCT00366600
Conditions
Healthy
Interventions
neratinib
Drug
Lead sponsor
Puma Biotechnology, Inc.
Industry
Eligibility
18 Years to 50 Years
Enrollment
56 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2006
U.S. locations
1
States / cities
Tacoma, Washington
Conditions
Breast Neoplasms, Neoplasms
Interventions
neratinib
Drug
Lead sponsor
Puma Biotechnology, Inc.
Industry
Eligibility
18 Years and older · Female only
Enrollment
136 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2018
U.S. locations
13
States / cities
Aurora, Colorado • Zion, Illinois • Shreveport, Louisiana + 7 more
Conditions
Breast Cancer
Interventions
Neratinib, Trastuzumab, Paclitaxel
Drug
Lead sponsor
Puma Biotechnology, Inc.
Industry
Eligibility
18 Years and older · Female only
Enrollment
479 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2018
U.S. locations
36
States / cities
Oxnard, California • Santa Rosa, California • Plainville, Connecticut + 32 more
Conditions
Anatomic Stage I Breast Cancer, Anatomic Stage II Breast Cancer, Anatomic Stage III Breast Cancer, Invasive Breast Lobular Carcinoma
Interventions
Endocrine Therapy, Biopsy of breast, Neratinib, Biospecimen Collection, Mammogram, Magnetic Resonance Imaging, Breast Surgery, Ultrasound
Procedure · Drug
Lead sponsor
Vanderbilt-Ingram Cancer Center
Other
Eligibility
18 Years and older
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2031
U.S. locations
5
States / cities
Atlanta, Georgia • Pittsburgh, Pennsylvania • Nashville, Tennessee + 2 more
Completed Phase 1 Interventional Results available

Study Evaluating HKI-272 in Tumors

NCT00146172
Conditions
Breast Neoplasms
Interventions
neratinib
Drug
Lead sponsor
Puma Biotechnology, Inc.
Industry
Eligibility
18 Years and older
Enrollment
73 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2003 – 2007
U.S. locations
5
States / cities
Tampa, Florida • Boston, Massachusetts • St Louis, Missouri + 2 more
Conditions
Breast Neoplasms, Breast Cancer, Breast Tumors, Angiosarcoma, TNBC - Triple-Negative Breast Cancer, HER2-positive Breast Cancer, HER2-negative Breast Cancer, Hormone Receptor Positive Tumor, Hormone Receptor Negative Tumor, Early-stage Breast Cancer, Locally Advanced Breast Cancer
Interventions
Standard Therapy, AMG 386 with or without Trastuzumab, AMG 479 (Ganitumab) plus Metformin, MK-2206 with or without Trastuzumab, AMG 386 and Trastuzumab, T-DM1 and Pertuzumab, Pertuzumab and Trastuzumab, Ganetespib, ABT-888, Neratinib, PLX3397, Pembrolizumab - 4 cycle, Talazoparib plus Irinotecan, Patritumab and Trastuzumab, Pembrolizumab - 8 cycle, SGN-LIV1A, Durvalumab plus Olaparib, SD-101 + Pembrolizumab, Tucatinib plus trastuzumab and pertuzumab, Cemiplimab, Cemiplimab plus REGN3767, Trilaciclib with or without trastuzumab + pertuzumab, SYD985 ([vic-]trastuzumab duocarmazine), Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumab, Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumab, Amcenestrant, Amcenestrant + Abemaciclib, Amcenestrant + Letrozole, ARX788, ARX788 + Cemiplimab, VV1 + Cemiplimab, Datopotamab deruxtecan, Datopotamab deruxtecan + Durvalumab, Zanidatamab, Lasofoxifene, Z-endoxifen, ARV-471, ARV-471 + Letrozole, ARV-471 + Abemaciclib, Endoxifen + Abemaciclib, Rilvegostomig + TDXd, Dan222 + Niraparib, Sarilumab + Cemiplimab + Paclitaxel, GSK 5733584, GSK 5733584 + Dostarlimab, Ivonescimab (20mg/kg Q3W)
Drug
Lead sponsor
QuantumLeap Healthcare Collaborative
Other
Eligibility
18 Years and older
Enrollment
5,000 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2031
U.S. locations
42
States / cities
Birmingham, Alabama • Scottsdale, Arizona • Tucson, Arizona + 36 more
Conditions
Triple Negative Breast Cancer, Early-stage Breast Cancer, HER2-positive Breast Cancer
Interventions
Neratinib
Drug
Lead sponsor
West Cancer Center
Other
Eligibility
18 Years and older
Enrollment
27 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2024
U.S. locations
1
States / cities
Germantown, Tennessee
Conditions
Breast Cancer
Interventions
HKI-272, Surgical Resection, Capecitabine, Ado-Trastuzumab Emtansine
Drug · Procedure
Lead sponsor
Dana-Farber Cancer Institute
Other
Eligibility
18 Years and older
Enrollment
140 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2024
U.S. locations
18
States / cities
San Francisco, California • Washington D.C., District of Columbia • Baltimore, Maryland + 11 more
Conditions
Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer, Metastatic Cervical Cancer
Interventions
Almac HER-Seq Assay
Diagnostic Test
Lead sponsor
Puma Biotechnology, Inc.
Industry
Eligibility
18 Years and older
Enrollment
1,583 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2021
U.S. locations
1
States / cities
Pittsburgh, Pennsylvania
Completed Phase 1 Interventional Accepts healthy volunteers

Study Evaluating TwoTablet Formulations of Neratinib (HKI-272)

NCT00814060
Conditions
Healthy Subjects
Interventions
neratinib
Drug
Lead sponsor
Puma Biotechnology, Inc.
Industry
Eligibility
18 Years to 50 Years
Enrollment
24 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2009
U.S. locations
1
States / cities
Tacoma, Washington
Conditions
Glioblastoma
Interventions
Temozolomide, Neratinib, QBS10072S, Abemaciclib, CC-115
Drug
Lead sponsor
David Reardon, MD
Other
Eligibility
18 Years and older
Enrollment
460 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2028
U.S. locations
12
States / cities
Birmingham, Alabama • Boston, Massachusetts • Rochester, Minnesota + 7 more
Conditions
Healthy
Interventions
Lansoprazole, Neratinib
Drug
Lead sponsor
Puma Biotechnology, Inc.
Industry
Eligibility
18 Years to 55 Years
Enrollment
15 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2014
U.S. locations
1
States / cities
Tempe, Arizona
Conditions
HER2 Positive Breast Carcinoma, Stage IV Breast Cancer AJCC v6 and v7
Interventions
Comprehensive Geriatric Assessment, Laboratory Biomarker Analysis, Neratinib, Pharmacological Study
Other · Drug
Lead sponsor
City of Hope Medical Center
Other
Eligibility
60 Years and older
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2022
U.S. locations
7
States / cities
Corona, California • Duarte, California • Lancaster, California + 4 more
Conditions
Malignant Female Reproductive System Neoplasm, Malignant Solid Neoplasm, Recurrent Malignant Female Reproductive System Neoplasm, Recurrent Malignant Solid Neoplasm
Interventions
Biopsy Procedure, Biospecimen Collection, Computed Tomography, Echocardiography Test, Magnetic Resonance Imaging, Multigated Acquisition Scan, Neratinib Maleate, Palbociclib
Procedure · Drug
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
70 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
192
States / cities
Birmingham, Alabama • Mobile, Alabama • Anchorage, Alaska + 153 more
Conditions
Early Stage HER2+ Breast Cancer
Interventions
Neratinib, Loperamide, Colestipol, Budesonide
Drug
Lead sponsor
Puma Biotechnology, Inc.
Industry
Eligibility
18 Years and older
Enrollment
563 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2021
U.S. locations
39
States / cities
Birmingham, Alabama • Corona, California • Fullerton, California + 36 more
Conditions
Breast Cancer
Interventions
Capecitabine and Neratinib.
Drug
Lead sponsor
University of Rochester
Other
Eligibility
18 Years and older
Enrollment
22 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2027
U.S. locations
1
States / cities
Rochester, New York
Conditions
Breast Cancer, HER2-positive Breast Cancer, ER Positive Breast Cancer, PR-Positive Breast Cancer
Interventions
Neratinib, Letrozole (L) or Anastrozole (A), Trastuzumab
Drug
Lead sponsor
Ruth O'Regan
Other
Eligibility
18 Years and older
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2027
U.S. locations
4
States / cities
Chicago, Illinois • Rochester, New York • Hershey, Pennsylvania + 1 more
Conditions
GastroEsophageal Cancer, Gastric Cancer
Interventions
Neratinib, Trastuzumab, Oxaliplatin, 5-Fluorouracil + leucovorin, Pembrolizumab
Drug
Lead sponsor
H. Lee Moffitt Cancer Center and Research Institute
Other
Eligibility
18 Years and older
Enrollment
8 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2028
U.S. locations
1
States / cities
Tampa, Florida
Conditions
Advanced Solid Tumor, Ovarian Cancer
Interventions
Neratinib 160 mg, Neratinib 200 mg, Neratinib 240 mg, Niraparib 100 mg, Niraparib 200 mg, Niraparib 300 mg, Niraparib at RP2D, Neratinib at RP2D
Drug
Lead sponsor
Virginia Commonwealth University
Other
Eligibility
18 Years and older
Enrollment
18 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2027
U.S. locations
1
States / cities
Richmond, Virginia
Conditions
Solid Tumor, Adult
Interventions
Neratinib, Divalproex Sodium
Drug
Lead sponsor
Virginia Commonwealth University
Other
Eligibility
18 Years and older
Enrollment
83 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2031
U.S. locations
1
States / cities
Richmond, Virginia
Conditions
Breast Cancer
Interventions
Temsirolimus, Neratinib
Drug
Lead sponsor
Puma Biotechnology, Inc.
Industry
Eligibility
18 Years and older
Enrollment
99 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2016
U.S. locations
4
States / cities
Goodyear, Arizona • Los Angeles, California • New York, New York
Conditions
Metastatic Colorectal Cancer
Interventions
Trastuzumab, Cetuximab, Neratinib, Guardant360 Diagnostic Test
Drug · Diagnostic Test
Lead sponsor
NSABP Foundation Inc
Network
Eligibility
18 Years and older
Enrollment
35 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2022
U.S. locations
48
States / cities
Anaheim, California • Baldwin Park, California • Bellflower, California + 40 more
Conditions
Gastric Cancer, Gastrointestinal Cancer, HER2 Gene Mutation
Interventions
Neratinib Pill, Fam-Trastuzumab Deruxtecan-Nxki (TDxD)
Drug
Lead sponsor
Fox Chase Cancer Center
Other
Eligibility
18 Years and older
Enrollment
18 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2027
U.S. locations
3
States / cities
Palo Alto, California • Buffalo, New York • Philadelphia, Pennsylvania
Conditions
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Locally Advanced Malignant Solid Neoplasm, Malignant Female Reproductive System Neoplasm, Metastatic HER2-Negative Breast Carcinoma, Metastatic Malignant Solid Neoplasm, Recurrent Endometrial Carcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Malignant Female Reproductive System Neoplasm, Recurrent Malignant Solid Neoplasm, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma, Unresectable HER2-Negative Breast Carcinoma, Unresectable Malignant Solid Neoplasm
Interventions
Alpelisib, Binimetinib, Biopsy Procedure, Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Bone Scan, Computed Tomography, Echocardiography Test, Fluorouracil, Fulvestrant, Ipatasertib, Leucovorin, Magnetic Resonance Imaging, Multigated Acquisition Scan, Mutation Carrier Screening, Neratinib Maleate, Nilotinib Hydrochloride Monohydrate, Olaparib, Oxaliplatin, Paclitaxel, Palbociclib, Panitumumab, Positron Emission Tomography, Selumetinib Sulfate, Sotorasib
Drug · Procedure · Biological
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
Not listed
Enrollment
2,900 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2030
U.S. locations
478
States / cities
Birmingham, Alabama • Mobile, Alabama • Anchorage, Alaska + 354 more