A Phase 1/2 Study of HKI-272 (Neratinib) in Combination With Paclitaxel (Taxol) in Subjects With Solid Tumors and Breast Cancer
Completed · Phase 1/Phase 2
Conditions studied: Advanced Breast Cancer, Advanced Malignant Solid Tumors, Breast Neoplasms
In brief
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.
Key facts
- Study ID
- NCT00445458
- Run by
- Puma Biotechnology, Inc.
- People needed
- 110
- Starts
- 2007-09-11
- Expected to finish
- 2018-02-07
- Last updated by the study team
- 2018-07-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Inclusion criteria for both parts of clinical trial:
- Good performance status
- Normal ejection fraction
- Adequate cardiac, kidney, and liver function
- Adequate blood counts
- At least one measurable target lesion
- Negative pregnancy test for female subjects
- Inclusion Criteria for Part 1 Only:
- Pathologically confirmed solid tumor not curable with available standard therapy
- Inclusion Criteria for Part 2 Only:
- Pathologically confirmed breast cancer
- HER2 positive tumor
- Prior treatment with Herceptin
You may not qualify if…
- Exclusion criteria for both parts of clinical trial:
- Major surgery, radiotherapy, chemotherapy or investigational agents within two weeks of treatment day 1
- 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
- Exclusion Criteria for Part 2 Only:
- More than 1 (arm A) or 3 (arm B) prior cytotoxic chemotherapy regimen for metastatic disease
Where it is running
- 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
Full record on ClinicalTrials.gov
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