A Phase I/II Study of HKI-272 in Combination With Paclitaxel in Subjects With Advanced Solid Tumors and Breast Cancer - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00445458

Purpose

The purposes of this study are:

to find the highest tolerable dose of HKI-272 in combination with Paclitaxel
to assess the safety of the combination of the two drugs
to obtain preliminary information on whether the combination of the two drugs has any effect on solid tumors

Condition	Intervention	Phase
Advanced Breast Cancer Advanced Malignant Solid Tumors Breast Neoplasms	Drug: HKI-272	Phase I Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Paclitaxel HKI-272

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase I/II Study of HKI-272 in Combination With Paclitaxel in Subjects With Advanced Solid Tumors and Breast Cancer

Further study details as provided by Wyeth:

Primary Outcome Measures:

Physical ExamsAdverse Event AssessmentRadiographic Tumor Assessment (CT, MRI, bone scan) [ Time Frame: 28 days part 1 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

ECGECHO/MUGALab values [ Time Frame: 16 weeks part 2 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	93
Study Start Date:	August 2007
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental HKI-272 240mg PO QD and paclitaxel 80mg/m2	Drug: HKI-272

Detailed Description:

The study will be conducted in two parts. In the first part, testing will be done to determine the highest tolerable dose of HKI-272 and Paclitaxel in patients with advanced solid tumors.

In the second part of the study, subjects with breast cancer will be enrolled to further test the safety of the drug combination, and to obtain preliminary data on the efficacy of the combination.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria for Both Parts of Clinical Trial:

Good performance status
Normal ejection fraction
Lab values within specified ranges
Negative pregnancy test for female subjects

Inclusion Criteria for Part 2 Only:

Pathologically confirmed breast cancer
HER2 positive tumor
Prior treatment with Herceptin

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
Normal QTc interval
Significant gastrointestinal disorder
Inability to swallow HKI-272 capsules
Prior exposure to HKI-272 or other HER2 targeted agents (except trastuzumab). Prior lapatinib is permitted in Phase 2 (arm B).
Treatment with a taxane within 3 months of treatment day 1
Serious active infection
Grade 2 or greater motor or sensory neuropathy

Exclusion Criteria for Part 2 Only:

- More than 1 (arm A) / 3 (arm B) prior cytotoxich chemotherapy regimen for metastatic disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445458

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Show 35 Study Locations

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3144A1-203
Study First Received:	March 8, 2007
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00445458
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

cancer
HKI-272
paclitaxel
breast cancer

Study placed in the following topic categories:

Skin Diseases
Paclitaxel
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009