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An Ascending and Multiple Dose Study of the Safety, Tolerability, and Pharmacokinetics of HKI-272 Administered Orally to Japanese Subjects With Advanced Solid Tumors


Phase 1
20 Years
N/A
Not Enrolling
Both
Tumors

Thank you

Trial Information

An Ascending and Multiple Dose Study of the Safety, Tolerability, and Pharmacokinetics of HKI-272 Administered Orally to Japanese Subjects With Advanced Solid Tumors


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety will be assessed through adverse event evaluation, physical exams, and laboratory evaluations. Efficacy will be assessed through radiographic evaluation.

Outcome Time Frame:

16 months

Safety Issue:

Yes

Principal Investigator

Puma

Investigator Role:

Study Director

Investigator Affiliation:

Biotechnology

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

3144A1-104

NCT ID:

NCT00397046

Start Date:

November 2006

Completion Date:

March 2009

Related Keywords:

  • Tumors
  • Advanced Malignant Solid Tumors

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