A Phase 1/2 Study of HKI-272 (Neratinib) in Combination With Paclitaxel (Taxol) in Subjects With Solid Tumors and Breast Cancer
NCT ID: NCT00445458
Last Updated: 2018-07-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
110 participants
INTERVENTIONAL
2007-09-11
2018-02-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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HKI-272 dose level 1
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.
HKI-272
Paclitaxel
HKI-272 dose level 2
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.
HKI-272
Paclitaxel
HKI-272 expanded MTD cohort, arm A
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.
HKI-272
Paclitaxel
HKI-272 expanded MTD cohort, arm B
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.
HKI-272
Paclitaxel
Interventions
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HKI-272
Paclitaxel
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Normal ejection fraction
* Adequate cardiac, kidney, and liver function
* Adequate blood counts
* At least one measurable target lesion
* Negative pregnancy test for female subjects
\- Pathologically confirmed solid tumor not curable with available standard therapy
* Pathologically confirmed breast cancer
* HER2 positive tumor
* Prior treatment with Herceptin
Exclusion Criteria
* Subjects with bone or skin as the only site of disease
* Active central nervous system metastases
* Significant cardiac disease or dysfunction
* Significant gastrointestinal disorder
* Inability or unwillingness to swallow HKI-272 capsules
* Prior exposure to HKI-272 or other HER2 targeted agents, except trastuzumab (Part 2 only). Prior lapatinib is permitted in arm B of part 2.
* Treatment with a taxane within 3 months of treatment day 1
* Grade 2 or greater motor or sensory neuropathy
* Pregnant or breast feeding women
* Known hypersensitivity to paclitaxel or Cremophor EL
* Prior treatment with anthracyclines with cumulative dose of \>400 mg/m\^2
* Any other cancer within 5 years with the exception of contralateral breast cancer, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin
\- More than 1 (arm A) or 3 (arm B) prior cytotoxic chemotherapy regimen for metastatic disease
18 Years
ALL
No
Sponsors
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Puma Biotechnology, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Puma
Role: STUDY_DIRECTOR
Biotechnology
Locations
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Scripps, Clinic General
La Jolla, California, United States
Moores UC San Diego Cancer Center
La Jolla, California, United States
Sharp Memorial Hospital
San Diego, California, United States
Boston University Medical Center
Boston, Massachusetts, United States
Mid-Michigan Physicians-HOS Division
Lansing, Michigan, United States
Oncology Care Associates
Saint Joseph, Michigan, United States
Columbia University Medical Center
New York, New York, United States
CTRC at The University of Texas Health Science Center
San Antonio, Texas, United States
Institut Jules Bordet Unite du Chimiotherapie
Brussels, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
AZ Groeninge Campus Maria's Voorzienigheid (MV)
Kortrijk, , Belgium
Oncologisch Centrum GZA - Location St Augustinus
Wilrijk, , Belgium
Princess Margaret Hospital University Health Network
Toronto, Ontario, Canada
The Hospital Affiliated Academy Military Medical Science, Chinese People's Liberation Army
Beijing, Beijing Municipality, China
Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality, China
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China
Tianjin Union Medicine Center Department of Oncology
Tianjin, Tianjin Municipality, China
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, , China
Peking Union Medical College Hospital of Chinese Academy of Medical Sciences
Beijing, , China
UNIMED Medical Institute
Hong Kong, , 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, India
M.M.F. Joshi Hospital & Ratna Memorial Hospital
Pune, Maharashtra, India
Tata Memorial Hospital
Mumbai, Parel, India
Birla Cancer Centre, S.M.S. Medical College & Hospital
Jaipur, Rajasthan, India
Wojewodzki Szpital Specjalistyczny im. Ludwika Rydygiera, Oddzial Onkologii
Krakow, , Poland
Oddzial Chemioterapii Centrum Onkologii Ziemii Lubelskiej
Lublin, , Poland
Yonsei University Health System - Severance Hospital
Seoul, , South Korea
Asan Medical Center, Division of Oncology, Department of Internal Medicine
Seoul, , South Korea
City Multifield Clinical Hospital #4 Department of chemotherapy, Dnipropetrovs'k State Medical Academy, Chair of Oncology and Medical Radiology
Dnipropetrovsk, , Ukraine
State Oncological Regional Treatment and Diagnostic Center Department of chemotherapy
Lviv, , Ukraine
Countries
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References
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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.
Other Identifiers
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3144A1-203 / B1891014
Identifier Type: -
Identifier Source: org_study_id
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