A Phase 1/2 Study of HKI-272 in Combination With Paclitaxel in Subjects With Solid Tumors and Breast Cancer
Sponsor study identifier
interventional
110
9 countries
32
Study Start
September 11, 2007
Actual (reported)Primary Completion
May 2011
Actual (reported)Study Completion
February 7, 2018
Actual (reported)The purpose of this study is to learn whether it is safe and effective to administer HKI-272 (neratinib) in combination with paclitaxel in patients with breast cancer.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 7, 2018
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 8, 2007
Actual (reported)March 9, 2007
Actual (reported)September 11, 2007
Actual (reported)May 2011
Actual (reported)February 7, 2018
Actual (reported)May 9, 2018
Actual (reported)Dose Limiting Toxicity Incidence of Neratinib in Combination With Paclitaxel
Dose Limiting Toxicity in subjects with solid tumors treated with neratinib, administered daily, in combination with paclitaxel 80 mg/m² IV on days 1, 8, and 15 of a 28 day cycle.
From first dose date through day 28
Maximum Tolerated Dose
Maximum Tolerated Dose (MTD) of neratinib, daily, in combination with paclitaxel 80 mg/m², intravenous at days 1, 8, and 15, associated with the dose limiting toxicity data.
From first dose date through day 28.
Objective Response Rate
Subjects with partial response (PR) or complete response (CR) with ERBB2 positive breast cancer treated at the maximum tolerated dose (MTD) of neratinib in combination with paclitaxel, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.0: CR, disappearance of all target lesions; PR, \>=30% decrease in the sum of the longest diameter of target lesions; and no progressive disease (PD) for non-target lesions, and no new lesions.
Part 1: Subjects with solid tumors receiving HKI-272 (neratinib) 160 mg daily by mouth in combination with paclitaxel 80 mg/m\^2 weekly IV.
Part 1: Subjects with solid tumors receiving HKI-272 (neratinib) 240 mg daily by mouth in combination with paclitaxel 80 mg/m\^2 weekly IV.
Scripps, Clinic General
La Jolla, California, 92037, United States
Moores UC San Diego Cancer Center
La Jolla, California, 92093, United States
Sharp Memorial Hospital
San Diego, California, 92123, United States
Boston University Medical Center
Boston, Massachusetts, 02118, United States
Mid-Michigan Physicians-HOS Division
Lansing, Michigan, 48912, United States
Oncology Care Associates
Saint Joseph, Michigan, 49085, United States
Columbia University Medical Center
New York, New York, 10032, United States
Chow LW, Xu B, Gupta S, Freyman A, Zhao Y, Abbas R, Vo Van ML, Bondarenko I. Combination neratinib (HKI-272) and paclitaxel therapy in patients with HER2-positive metastatic breast cancer. Br J Cancer. 2013 May 28;108(10):1985-93. doi: 10.1038/bjc.2013.178. Epub 2013 Apr 30.
Puma
Biotechnology
110 participants (actual enrollment reported by the registry).
First Submitted
March 8, 2007
First Posted
March 9, 2007
Study Start
September 11, 2007
Actual (reported)From first dose date to progression or last tumor assessment, up to 140 weeks
Maximum Plasma Concentration of Neratinib
Samples taken at 0 hour and at 1, 2, 4, 6, 8, and 24 hours postdose on Day 15 of Cycle 1, and 1 predose sample on Day 1 in Cycle 1.
Area Under the Concentration-time Curve 0-24
Samples taken at 0 hour and at 1, 2, 4, 6, 8, and 24 hours postdose on Day 15 of Cycle 1, and 1 predose sample on Day 1 in Cycle 1.
Part 2: Subjects with metastatic breast cancer who have not received more than 1 prior cytotoxic chemotherapy treatment regimen for metastatic disease receiving HKI-272 (neratinib) 240 mg daily by mouth in combination with paclitaxel 80 mg/m\^2 weekly IV.
Part 2: Subjects with metastatic breast cancer who have not received more than 3 prior cytotoxic chemotherapy treatment regimen for metastatic disease receiving HKI-272 (neratinib) 240 mg daily by mouth in combination with paclitaxel 80 mg/m\^2 weekly IV.
Contact the study team to confirm eligibility.
CTRC at The University of Texas Health Science Center
San Antonio, Texas, 78229, United States
Institut Jules Bordet Unite du Chimiotherapie
Brussels, 1000, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
AZ Groeninge Campus Maria's Voorzienigheid (MV)
Kortrijk, 8500, Belgium
Oncologisch Centrum GZA - Location St Augustinus
Wilrijk, 2610, Belgium
Princess Margaret Hospital University Health Network
Toronto, Ontario, M5G 2M9, Canada
The Hospital Affiliated Academy Military Medical Science, Chinese People's Liberation Army
Beijing, Beijing Municipality, 100071, China
Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality, 100853, China
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300060, China
Tianjin Union Medicine Center Department of Oncology
Tianjin, Tianjin Municipality, 300121, China
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, 100021, China
Peking Union Medical College Hospital of Chinese Academy of Medical Sciences
Beijing, 100032, China
UNIMED Medical Institute
Hong Kong, 0, Hong Kong
Department of Medicine, Queen Mary Hospital
Hong Kong, Hong Kong
Department of Surgery Queen Mary Hospital
Hong Kong, Hong Kong
Jehangir Clinical Development Centre, Jehangir Hospital Premises
Pune, Maharashtra, 411001, India
M.M.F. Joshi Hospital & Ratna Memorial Hospital
Pune, Maharashtra, 411004, India
Tata Memorial Hospital
Mumbai, Parel, 400012, India
Birla Cancer Centre, S.M.S. Medical College & Hospital
Jaipur, Rajasthan, 302004, India
Wojewodzki Szpital Specjalistyczny im. Ludwika Rydygiera, Oddzial Onkologii
Krakow, 31-826, Poland
Oddzial Chemioterapii Centrum Onkologii Ziemii Lubelskiej
Lublin, 20-090, Poland
Yonsei University Health System - Severance Hospital
Seoul, 120-752, South Korea
Asan Medical Center, Division of Oncology, Department of Internal Medicine
Seoul, 138-736, South Korea
City Multifield Clinical Hospital #4 Department of chemotherapy, Dnipropetrovs'k State Medical Academy, Chair of Oncology and Medical Radiology
Dnipropetrovsk, 49102, Ukraine
State Oncological Regional Treatment and Diagnostic Center Department of chemotherapy
Lviv, 79031, Ukraine
Primary Completion
May 2011
Actual (reported)Study Completion
February 7, 2018
Actual (reported)Last Updated
July 26, 2018
Results First Posted
May 9, 2018
Record last verified: 2018-06
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