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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


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 events

Objective 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- 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

Page last updated: August 23, 2015

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