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Study Evaluating the Combination of Neratinib and Capecitabine in Solid Tumors and Breast Cancer

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase II, Phase I Treatment Active 18 and over Pharmaceutical / Industry 3144A1-2206
NCT00741260

Trial Description

Summary

This is a world wide phase 1/2, open-label, study of neratinib in combination with capecitabine, conducted in 2 parts.

In Part 1, 3 to 6 subjects with solid tumors will be enrolled in each dose group of the combination of neratinib and capecitabine. Each subject will participate in only 1 dose group. Additional subjects may be included at any dose level to further assess the safety and tolerability at that dose level.

In Part 2, up to 60 subjects with erbB-2 positive metastatic breast cancer will receive treatment with the combination of neratinib and capecitabine at the maximum tolerated dose level, as determined in Part 1. Depending on the safety and activity profile observed during the dose escalation phase, the dose selected for Part 2 may be adjusted, if appropriate. In case one test article of the combination is discontinued due to intolerance the other test article can be administered alone.

The primary objectives of Part 1 are to assess the safety and tolerability, and to define the Maximum tolerated dose (MTD) of neratinib in combination with capecitabine in subjects with advanced solid tumors. The primary objective of Part 2 of this study is to confirm the MTD determined in Part 1.

The secondary objective of Part 1 is to collect information on preliminary anti-tumor activity of the combination of neratinib and capecitabine.

Secondary objectives for Part 2 are to collect pharmacokinetic information and to obtain additional efficacy data, such as Objective Response Rate, for subjects with erbB-2 positive breast cancer treated at the MTD of neratinib + capecitabine.

Eligibility Criteria

Main Inclusion Criteria:

Part 1: confirmed pathologic diagnosis of a solid tumor not curable with available therapies for which neratinib plus capecitabine is a reasonable treatment option.

Part 2: confirmed pathologic diagnosis of breast cancer, metastatic or locally advanced.

Part 2: erbB-2 gene amplified tumor (FISH or CISH) or erbB-2 overexpression (IHC 3+, or IHC2+ with FISH or CISH confirmation), based on local testing, or based on centralized FISH testing prior to day 1.

Part 2: disease progression following at least 1 prior trastuzumab containing treatment regimen (at least 6 weeks) for metastatic or locally advanced disease. (Prior adjuvant trastuzumab is allowed but not required).

Part 2: prior treatment with both a taxane and an anthracycline given sequentially or concurrently (any treatment setting).

Parts 1+2: At least 1 measurable lesion as defined by RECIST criteria.

Parts 1+2: LVEF within institutional limits of normal.

Main Exclusion Criteria:

Part 2: prior treatment withcapecitabine, or any erbB-2 targeted agents except trastuzumab.

Part 2: prior treatment with anthracyclines with a cumulative dose of doxorubicin of greater than 400 mg/m2, epirubicin dose of greater than 800 mg/m2, or the equivalent dose for other anthracyclines.

Parts 1+2: Subjects with bone or skin as the only site of disease.

Parts 1+2: Active central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Subjects with a history of CNS metastases or cord compression are allowable if treated, clinically stable for at least three months, and off anticonvulsants before first dose of test article.

Parts 1+2: Any other cancer within 5 years prior to screening with the exception of adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin.

Trial Contact Information

Trial Lead Organizations/Sponsors

Wyeth Research

Medical Monitor

Study Director

Trial Manager
		Email: clintrialparticipation@wyeth.com

Trial Sites

U.S.A.

Alabama

Mobile

Study Site

California

Long Beach

Study Site

Florida

Fort Lauderdale

Study Site

Orlando

Study Site

Idaho

Coeur d Alene

Study Site

Illinois

Galesburg

Study Site

Indiana

Lafayette

Study Site

New York

Lake Success

Study Site

Staten Island

Study Site

Ohio

Dayton

Study Site

Texas

Corpus Christi

Study Site

Richardson

Study Site

Hong Kong

Hong Kong

Study Site

Spain

Barcelona

Study Site

Madrid

Study Site

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00741260
Information obtained from ClinicalTrials.gov on April 20, 2009

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.