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NCT00741260 · ClinicalTrials.gov registry record · Phase 1

Study Evaluating The Combination Of Neratinib And Capecitabine In Solid Tumors And Breast Cancer

A Phase 1 study of Breast Cancer, sponsored by Puma Biotechnology.

Completed
Registry status
Phase 1
Development phase
105
Enrollment target
20
Study locations

NCT00741260 is a Phase 1 study of Breast Cancer that has completed, run by Puma Biotechnology. The registered enrollment target is 105 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 17 states.

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The verdict

NCT00741260, a Phase 1 study of Breast Cancer, has completed, sponsored by Puma Biotechnology.

COMPLETED
Registry status
Phase 1
Development phase
105 participants
Enrollment target
20
Study locations

Study 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 9 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. In addition 20 subjects with prior lapatinib exposure will be enrolled in Part 2. 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.

Conditions Studied

Breast Cancer

Interventions

  • DRUG Capecitabine
  • DRUG Neratinib

Study Locations (20)

California

  • Pacific Shores Medical Group - Long Beach
  • University of Southern California - Los Angeles

Texas

  • HOPE Oncology - Richardson
  • Cancer Therapy and Research Center at The UT Health Science Center Institute for Drug Development - San Antonio

Beijing Municipality

  • Cancer Hospital, Chinese Academy of Medical Sciences - Beijing
  • Peking Union Medical College Hospital of Chinese Academy of Medical Sciences - Beijing

Alabama

  • USA Mitchell Cancer Institute - Mobile

Florida

  • Florida Hospital Cancer Institute - Orlando

Idaho

  • Kootenai Cancer Center - Post Falls

Indiana

  • The Care Group, LLC. dba Horizon Oncology Center - Lafayette

Missouri

  • Washington University School of Medicine Siteman Cancer Center - St Louis

Trial Details

FieldValue
Enrollment Target 105 participants
Start Date 2008-12-09
Est. Completion 2018-06
Phase Phase 1

Sponsor

Puma Biotechnology

28 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00741260

The ClinicalTrials.gov registry entry for NCT00741260 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The listed sponsor is Puma Biotechnology, which has 28 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Capecitabine is the first listed.

NCT00741260 reports 20 study locations spanning 17 distinct geographic areas - top geographies include California, Texas, Beijing Municipality.

Frequently Asked Questions

What is clinical trial NCT00741260 about?

NCT00741260 is a clinical study titled "Study Evaluating The Combination Of Neratinib And Capecitabine In Solid Tumors And Breast Cancer". 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 9 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 grou...

What is the current status of trial NCT00741260?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 105 participants. The study started on 2008-12-09. Estimated completion is 2018-06.

What conditions does trial NCT00741260 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT00741260?

The interventions under investigation include: Capecitabine (DRUG), Neratinib (DRUG).

Who is sponsoring clinical trial NCT00741260?

This trial is sponsored by Puma Biotechnology, which has 28 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00741260 being conducted?

This trial has 20 study locations across Alabama, California, Florida, Idaho, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.