Study Evaluating The Combination Of Neratinib And Capecitabine In Solid Tumors And Breast Cancer

Completed · Phase 1/Phase 2

Conditions studied: Breast Cancer

In brief

This is a world wide phase 1/2, open-label, study of neratinib in combination with capecitabine, conducted in 2 parts. 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.

Key facts

Study ID

NCT00741260

Run by

Puma Biotechnology, Inc.

People needed

105

Starts

2008-12-09

Expected to finish

2018-06-01

Last updated by the study team

2018-09-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• PART 1:
• 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).

You may not qualify if…

• PART 2:
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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