Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Study Evaluating The Combination Of Neratinib And Capecitabine In Solid Tumors And Breast Cancer
NCT00741260 · View on ClinicalTrials.gov ↗
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
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
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2008-12-09 |
| Est. Completion | 2018-06 |
| Phase | Phase 1 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Puma Biotechnology, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00741260 reports 20 study locations spanning 17 distinct geographic areas — top geographies include California, Texas, Beijing Municipality. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00741260?
The interventions under investigation include: Capecitabine (DRUG), Neratinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00741260?
This trial is sponsored by Puma Biotechnology, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.