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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00445458
Other study ID # 3144A1-203 / B1891014
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date September 11, 2007
Est. completion date February 7, 2018

Study information

Verified date June 2018
Source Puma Biotechnology, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date February 7, 2018
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design


Intervention

Drug:
HKI-272

Paclitaxel


Locations

Country Name City State
Belgium Institut Jules Bordet Unite du Chimiotherapie Brussels
Belgium Universitair Ziekenhuis Gent Gent
Belgium AZ Groeninge Campus Maria's Voorzienigheid (MV) Kortrijk
Belgium Oncologisch Centrum GZA - Location St Augustinus Wilrijk
Canada Princess Margaret Hospital University Health Network Toronto Ontario
China Cancer Hospital, Chinese Academy of Medical Sciences Beijing
China Chinese People's Liberation Army General Hospital Beijing Beijing
China Peking Union Medical College Hospital of Chinese Academy of Medical Sciences Beijing
China The Hospital Affiliated Academy Military Medical Science, Chinese People's Liberation Army Beijing Beijing
China Tianjin Cancer Hospital TianJin Tianjin
China Tianjin Union Medicine Center Department of Oncology Tianjin Tianjin
Hong Kong Department of Medicine, Queen Mary Hospital Hong Kong
Hong Kong Department of Surgery Queen Mary Hospital Hong Kong
Hong Kong UNIMED Medical Institute Hong Kong
India Birla Cancer Centre, S.M.S. Medical College & Hospital Jaipur Rajasthan
India Tata Memorial Hospital Mumbai Parel
India Jehangir Clinical Development Centre, Jehangir Hospital Premises Pune Maharashtra
India M.M.F. Joshi Hospital & Ratna Memorial Hospital Pune Maharashtra
Korea, Republic of Asan Medical Center, Division of Oncology, Department of Internal Medicine Seoul
Korea, Republic of Yonsei University Health System - Severance Hospital Seoul
Poland Wojewodzki Szpital Specjalistyczny im. Ludwika Rydygiera, Oddzial Onkologii Krakow
Poland Oddzial Chemioterapii Centrum Onkologii Ziemii Lubelskiej Lublin
Ukraine City Multifield Clinical Hospital #4 Department of chemotherapy, Dnipropetrovs'k State Medical Academy, Chair of Oncology and Medical Radiology Dnipropetrovsk
Ukraine State Oncological Regional Treatment and Diagnostic Center Department of chemotherapy Lviv
United States Boston University Medical Center Boston Massachusetts
United States Moores UC San Diego Cancer Center La Jolla California
United States Scripps, Clinic General La Jolla California
United States Mid-Michigan Physicians-HOS Division Lansing Michigan
United States Columbia University Medical Center New York New York
United States Oncology Care Associates Saint Joseph Michigan
United States CTRC at The University of Texas Health Science Center San Antonio Texas
United States Sharp Memorial Hospital San Diego California

Sponsors (1)

Lead Sponsor Collaborator
Puma Biotechnology, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  China,  Hong Kong,  India,  Korea, Republic of,  Poland,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dose Limiting Toxicity Incidence of Neratinib in Combination With Paclitaxel Dose Limiting Toxicity in subjects with solid tumors treated with neratinib, administered daily, in combination with paclitaxel 80 mg/m² IV on days 1, 8, and 15 of a 28 day cycle. From first dose date through day 28
Primary Maximum Tolerated Dose Maximum Tolerated Dose (MTD) of neratinib, daily, in combination with paclitaxel 80 mg/m², intravenous at days 1, 8, and 15, associated with the dose limiting toxicity data. From first dose date through day 28.
Primary Objective Response Rate Subjects with partial response (PR) or complete response (CR) with ERBB2 positive breast cancer treated at the maximum tolerated dose (MTD) of neratinib in combination with paclitaxel, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.0: CR, disappearance of all target lesions; PR, >=30% decrease in the sum of the longest diameter of target lesions; and no progressive disease (PD) for non-target lesions, and no new lesions. From first dose date to progression or last tumor assessment, up to 140 weeks
Secondary Maximum Plasma Concentration of Neratinib Maximum plasma concentration of neratinib; after each dosing of neratinib on Cycle 1 of Day 15, blood samples taken at regular time points. Samples taken at 0 hour and at 1, 2, 4, 6, 8, and 24 hours postdose on Day 15 of Cycle 1, and 1 predose sample on Day 1 in Cycle 1.
Secondary Area Under the Concentration-time Curve 0-24 Area under the concentration-time curve of neratinib; after each dosing of neratinib on Cycle 1 of Day 15, blood samples taken at regular time points. Samples taken at 0 hour and at 1, 2, 4, 6, 8, and 24 hours postdose on Day 15 of Cycle 1, and 1 predose sample on Day 1 in Cycle 1.
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