A Phase 1/2 Study Of HKI-272 (Neratinib) in Combination With Trastuzumab (Herceptin) In Subjects With Advanced Breast Cancer
Information source: Puma Biotechnology, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Advanced Breast Cancer
Intervention: HKI-272 (Drug); Herceptin (Drug); HKI-272 (Drug); Herceptin (Drug); HKI-272 (Drug); Herceptin (Drug)
Phase: Phase 1/Phase 2
Status: Active, not recruiting
Sponsored by: Puma Biotechnology, Inc. Official(s) and/or principal investigator(s): Puma, Study Director, Affiliation: Biotechnology
Summary
The purpose of this study is to learn whether it is safe and effective to administer HKI-272
(neratinib) in combination with Herceptin in patients with advanced breast cancer.
Clinical Details
Official title: A Phase I/II Study of HKI-272 in Combination With Trastuzumab (Herceptin) in Subjects With Advanced Breast Cancer
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of participants with adverse eventsObjective response rate
Secondary outcome: Observed maximum concentration of HKI-272 (neratinib)Time of maximum concentration of HKI-272 (neratinib) Area under the plasma concentration versus time curve of HKI-272 (neratinib)
Detailed description:
Open label phase 1/2 study of ascending multiple oral doses of HKI-272 in combination with
IV Herceptin in subjects with advanced HER2+ breast cancer. Three to six subjects will be
enrolled in each dose group. Adverse events and dose limiting toxicities will be assessed
from the first dose of study drug though day 21. When the maximum tolerated dose of HKI-272
plus Herceptin is determined, an additional 30 subjects will be enrolled at that dose level,
and followed for progression free survival for approximately 1 year.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Pathologic diagnosis of breast cancer with current stage IIIB, IIIC or IV not curable
by available therapy
- Progression following at least one Herceptin-containing cytotoxic chemotherapy
regimen (neoadjuvant, adjuvant, or metastatic setting)
- HER2 positive breast cancer
- At least one measurable target lesion
- Adequate performance status
- Adequate cardiac, kidney, and liver function
- Adequate blood counts
- Willingness of all subjects who are not surgically sterile or post menopausal to use
acceptable methods of birth control
Exclusion Criteria:
- More than 3 prior cytotoxic chemotherapy regimens for locally advanced or metastatic
disease
- Major surgery, chemotherapy, radiotherapy, investigational agents, Herceptin or other
cancer therapy within 2 weeks of treatment day 1
- Prior treatment with anthracyclines with cumulative dose of >400 mg/m^2
- Extensive visceral disease
- Active central nervous system metastases
- Pregnant or breast feeding women
- Significant chronic or recent acute gastrointestinal disorder with diarrhea as a
major symptom
- Prior exposure to HKI-272 or other HER2 targeted agents (except Herceptin and Tykerb)
- Significant cardiac disease or dysfunction
- History of life-threatening hypersensitivity to Herceptin
- Inability or unwillingness to swallow HKI-272 capsules
- 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
Locations and Contacts
Investigational Site, Beijing 100021, China
Investigational Site, Beijing 100071, China
Investigational Site, Beijing 100853, China
Investigational Site, Paris 75005, France
Investigational Site, Saint-Herblain 44805, France
Investigational Site, Lausanne 1011, Switzerland
Investigational Site, Lausanne CH-1011, Switzerland
Investigational Site, Duarte, California 91010-3000, United States
Investigational Site, Duarte, California 91010, United States
Investigational Site, Los Angeles, California 90033, United States
Investigational Site, Pasadena, California 91105, United States
Investigational Site, Nanjing, Jiangsu 210002, China
Investigational Site, Baltimore, Maryland 21201, United States
Investigational Site, Durham, North Carolina 27710, United States
Investigational Site, Philadelphia, Pennsylvania 19111, United States
Investigational Site, Tianjin, Tianjin 300121, China
Additional Information
Starting date: April 2007
Last updated: April 28, 2015
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