Study Evaluating The Combination Of Neratinib And Capecitabine In Solid Tumors And Breast Cancer
NCT ID: NCT00741260
Last Updated: 2018-09-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
105 participants
INTERVENTIONAL
2008-12-09
2018-06-30
Brief Summary
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In Part 1, 3 to 9 subjects with solid tumors will be enrolled in each dose group of the combination of neratinib and capecitabine. Each subject will participate in only 1 dose group.
Additional subjects may be included at any dose level to further assess the safety and tolerability at that dose level.
In Part 2, up to 60 subjects with erbB-2 positive metastatic breast cancer will receive treatment with the combination of neratinib and capecitabine at the maximum tolerated dose level, as determined in Part 1. In addition 20 subjects with prior lapatinib exposure will be enrolled in Part 2.
Depending on the safety and activity profile observed during the dose escalation phase, the dose selected for Part 2 may be adjusted, if appropriate. In case one test article of the combination is discontinued due to intolerance the other test article can be administered alone.
The primary objectives of Part 1 are to assess the safety and tolerability, and to define the maximum tolerated dose (MTD) of neratinib in combination with capecitabine in subjects with advanced solid tumors.
The primary objective of Part 2 of this study is to confirm the MTD determined in Part 1.
The secondary objective of Part 1 is to collect information on preliminary anti-tumor activity of the combination of neratinib and capecitabine.
Secondary objectives for Part 2 are to collect pharmacokinetic information and to obtain additional efficacy data, such as Objective Response Rate, for subjects with erbB-2 positive breast cancer treated at the MTD of neratinib + capecitabine.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Neratinib and Capecitabine (Dose Level 1)
Neratinib 160 mg and Capecitabine 1500 mg/m\^2
Neratinib
Neratinib orally once daily continually
Capecitabine
Capecitabine orally on days 1-14 of each 21 day cycle
Neratinib and Capecitabine (Dose Group 2)
Neratinib 240 mg and Capecitabine 1500 mg/m\^2
Neratinib
Neratinib orally once daily continually
Capecitabine
Capecitabine orally on days 1-14 of each 21 day cycle
Neratinib and Capecitabine (Dose Group 3)
Neratinib 240 mg and Capecitabine 2000 mg/m\^2
Neratinib
Neratinib orally once daily continually
Capecitabine
Capecitabine orally on days 1-14 of each 21 day cycle
Neratinib and Capecitabine (Dose Group 4)
Neratinib 200 mg and Capecitabine 2000 mg/m\^2
Neratinib
Neratinib orally once daily continually
Capecitabine
Capecitabine orally on days 1-14 of each 21 day cycle
Neratinib and Capecitabine (Dose Group 5)
Neratinib 160 mg and Capecitabine 2000 mg/m\^2
Neratinib
Neratinib orally once daily continually
Capecitabine
Capecitabine orally on days 1-14 of each 21 day cycle
Neratinib and Capecitabine MTD (Dose Group 6)
Neratinib and Capecitabine Maximum Tolerated Dose without prior lapatinib
Neratinib
Neratinib orally once daily continually
Capecitabine
Capecitabine orally on days 1-14 of each 21 day cycle
Neratinib and Capecitabine MTD (Dose Group 7)
Neratinib and Capecitabine Maximum Tolerated Dose with prior lapatinib
Neratinib
Neratinib orally once daily continually
Capecitabine
Capecitabine orally on days 1-14 of each 21 day cycle
Interventions
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Neratinib
Neratinib orally once daily continually
Capecitabine
Capecitabine orally on days 1-14 of each 21 day cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* confirmed pathologic diagnosis of a solid tumor not curable with available therapies for which neratinib plus capecitabine is a reasonable treatment option.
PART 2:
* confirmed histologically and/or cytologically confirmed diagnosis of breast cancer, metastatic or locally advanced.
* erbB-2 gene amplified tumor (FISH or CISH) or erbB-2 overexpression (IHC 3+, or IHC2+ with FISH or CISH confirmation), based on local testing, or based on centralized FISH testing prior to day 1.
* disease progression on or following at least 1 prior trastuzumab containing treatment regimen (at least 6 weeks) for metastatic or locally advanced disease. (Prior adjuvant trastuzumab is allowed but not required). A 2 week period is required between the last dose of trastuzumab treatment and first dose of the test article.
* Prior treatment with a taxane in the neoadjuvant, adjuvant, locally advanced, and/or metastatic disease treatment setting.
PARTS 1 and 2:
* At least 1 measurable lesion as defined by RECIST criteria.
* LVEF within institutional range of normal as measured by multi-gated acquisition (MUGA) or echocardiogram (ECHO).
Exclusion Criteria
* prior treatment with capecitabine, lapatinib (20 subjects with prior lapatinib exposure will be enrolled) or any erbB-2 targeted agents except trastuzumab. Treatment with erbB-2 targeted therapy must exceed 2 weeks (14 days) in order to be exclusionary.
* prior treatment with anthracyclines with a cumulative dose of doxorubicin of greater than 400 mg/m², epirubicin dose of greater than 800 mg/m², or the equivalent dose for other anthracyclines.
PARTS 1 and 2:
* Subjects with bone as the only site of disease.
* Active uncontrolled or symptomatic central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Subjects with a history of CNS metastases or cord compression are allowable if they have been considered definitively treated and are off anticonvulsants and steroids for at least 4 weeks before the first dose of test article.
* Any other cancer within 5 years prior to screening with the exception of adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin.
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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USA Mitchell Cancer Institute
Mobile, Alabama, United States
Pacific Shores Medical Group
Long Beach, California, United States
University of Southern California
Los Angeles, California, United States
Florida Hospital Cancer Institute
Orlando, Florida, United States
Kootenai Cancer Center
Post Falls, Idaho, United States
The Care Group, LLC. dba Horizon Oncology Center
Lafayette, Indiana, United States
Washington University School of Medicine Siteman Cancer Center
St Louis, Missouri, United States
Arena Oncology Associates, PC
Lake Success, New York, United States
Dayton Clinical Oncology Program
Dayton, Ohio, United States
Berks Hematology Oncology
West Reading, Pennsylvania, United States
HOPE Oncology
Richardson, Texas, United States
Cancer Therapy and Research Center at The UT Health Science Center Institute for Drug Development
San Antonio, Texas, United States
Mater Private Centre for HOCA
South Brisbane, Queensland, Australia
Border Medical Oncology
Wodonga, Victoria, Australia
Associacao Hospitalar Moinhos de Vento Instituto de Edicacao e Pesquisa
Porto Alegre, Rio Grande do Sul, Brazil
Associacao Hospital de Caridade Ijui
Ijuí, RS - Brazil, Brazil
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital of Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
The Hospital Affiliated Academy Military Medical Science, Chinese People's Liberation Army
Beijing, , China
University Hospital Center Zagreb Department of Oncology
Zagreb, , Croatia
UNIMED Medical Institute, Comprehensive Centre for Breast Diseases
Hong Kong, , Hong Kong
Orszagos Onkologiai Intezet "B" Belgyogyaszati osztaly
Budapest, , Hungary
Josa Andras Oktatokorhaz / Onkoradiologiai Osztaly
Nyíregyháza, , Hungary
Republican Clinical Oncology Dispensary
Kazan', , Russia
GUZ Perm Regional Oncology Dispensary
Perm, , Russia
Leningrad Regional Oncology Dispensary
Saint Petersburg, , Russia
GUZ City Clinical Oncology Dispensary
Saint Petersburg, , Russia
Saint-Petersburg State Medical University n.a. acad. I.P. Pavlov, Laboratory of Thoracic Oncology of Pulmonology Research Institute
Saint Petersburg, , Russia
Johns Hopkins Singapore International Medical Centre
Singapore, , Singapore
Yonsei University Health System-Severance Hospital, Yonsei University College of Medicine
Seoul, , South Korea
Department of Hematology/Oncology, Samsung Medical Center
Seoul, , South Korea
Asan Medical Center Department of Medicine Division of Oncology
Seoul, , South Korea
Hospital Vall d'Hebron
Barcelona, , Spain
Hospital Gregorio Maranon
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Countries
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References
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Saura C, Garcia-Saenz JA, Xu B, Harb W, Moroose R, Pluard T, Cortes J, Kiger C, Germa C, Wang K, Martin M, Baselga J, Kim SB. Safety and efficacy of neratinib in combination with capecitabine in patients with metastatic human epidermal growth factor receptor 2-positive breast cancer. J Clin Oncol. 2014 Nov 10;32(32):3626-33. doi: 10.1200/JCO.2014.56.3809. Epub 2014 Oct 6.
Other Identifiers
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3144A1-2206 / B1891017
Identifier Type: -
Identifier Source: org_study_id
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