A Study Of The Safety And Tolerability Of HKI-272 Administered Orally To Japanese Subjects With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00397046
Recruitment Status : Completed
First Posted : November 8, 2006
Results First Posted : February 16, 2018
Last Update Posted : February 16, 2018
Information provided by (Responsible Party):
Puma Biotechnology, Inc.

Brief Summary:
The purpose of this study is to assess the tolerability and safety of HKI-272, and to determine the maximum dose that can safety be given. The secondary purpose of this study is to determine how the body uses and gets rid of HKI-272 and to assess whether HKI-272 is effective for the treatment of advanced solid tumors.

Condition or disease Intervention/treatment Phase
Tumors Drug: neratinib Phase 1

Detailed Description:
This is a phase 1 open-label sequential-group study of ascending single and multiple oral doses administered to subjects with advanced solid tumors. Each subject will participate in only 1 dose group and will receive a single dose of test article, followed by a 1-week observation period, and then will receive the test article administered once-daily by mouth in cycles consisting of 28 days. Subjects will be enrolled in groups of 3 to 6. Adverse events and dose-limiting toxicities will be assessed from the first single dose.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Ascending and Multiple Dose Study of the Safety, Tolerability, and Pharmacokinetics of HKI-272 Administered Orally to Japanese Subjects With Advanced Solid Tumors
Actual Study Start Date : November 2006
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Neratinib

Arm Intervention/treatment
Experimental: Neratinib Drug: neratinib

Primary Outcome Measures :
  1. Safety and Tolerability of Neratinib of MTD [ Time Frame: First dose date through 21 days ]
    Number of subjects with dose-limiting toxicity (DLT). DLT was assessed from the time of administration of the first single dose to the end of 14 days of continual treatment (i.e., during 21 days from the first dose in the single dose period).

Secondary Outcome Measures :
  1. Objective Response Rate [ Time Frame: From first dose date to progression/PD or last tumor assessment ]
    Subjects with CR or PR. Objective response rate according to recist criteria.

  2. Clinical Benefit Rate [ Time Frame: From first dose date to progression/death or last assessment ]
    Subjects with confirmed Complete Response (CR) or confirmed Partial Response (PR), or Stable Disease (SD) >= 24 weeks.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria

  1. Diagnosis of metastatic or advanced cancer that has failed standard effective therapy
  2. Life expectancy of at least 12 weeks and adequate performance status
  3. Adequate bone marrow, kidney and liver function
  4. Willingness of male and female subjects who are not surgically sterile or post-menopausal to use adequate methods of birth control

Exclusion Criteria

  1. Any anticancer chemotherapy, radiotherapy immunotherapy or investigational agents within 4 weeks of first dose of HKI-272
  2. Inadequate cardiac function
  3. Surgery within 2 weeks of first dose of HKI-272
  4. Active central nervous system metastases (i.e., symptomatic, required use of corticosteroids and/or progressive growth)
  5. Significant gastrointestinal disorder with diarrhea as a major symptom
  6. Pregnant or breast feeding women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00397046

The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto, Tokyo, Japan, 135-8550
Shizuoka Cancer Center
Shizuoka, Japan, 1411-8777
Sponsors and Collaborators
Puma Biotechnology, Inc.
Study Director: Puma Biotechnology

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Puma Biotechnology, Inc. Identifier: NCT00397046     History of Changes
Other Study ID Numbers: 3144A1-104
First Posted: November 8, 2006    Key Record Dates
Results First Posted: February 16, 2018
Last Update Posted: February 16, 2018
Last Verified: August 2017

Keywords provided by Puma Biotechnology, Inc.:
Advanced Malignant Solid Tumors