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Study Evaluating Neratinib (HKI-272) In Combination With Vinorelbine In Subjects With Solid Tumors And Metastatic Breast Cancer
NCT00706030 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to identify the highest tolerable dose of neratinib (HKI-272) in combination with vinorelbine and to assess the safety of the combination of the two drugs as well as to obtain preliminary information on whether the combination of the two drugs has any effect on solid tumors. The study will be conducted in two parts. In the first part, testing will be done on up to 12 subjects to determine the highest tolerable dose of HKI-272 and vinorelbine in patients with advanced solid tumors. In the second part of the study, approximately 60 additional subjects with metastatic ErbB-2-positive breast cancer, with no prior exposure to lapatinib, are planned to be added to better define the tolerability and preliminary activity of HKI-272 in combination with vinorelbine. Up to 20 additional subjects with ErbB-2-positive breast cancer with prior lapatinib exposure are also planned to be enrolled in part 2 for exploratory analyses.
Conditions Studied
Interventions
- DRUG vinorelbine
- DRUG neratinib
Study Locations (20)
Other
- AZ Klina Brasschaat — Brasschaat
- Institut Jules Bordet — Brussels
- St.-Augustinus Hospital Oncology Department — Wilrijk
- Centre Paul Papin — Angers
- Institut Paoli Calmette — Marseille
- Institut Curie, Département d'Oncologie Médicale — Paris
- Institut Claudius Regaud — Toulouse
- Queen Mary Hospital — Hong Kong
New York
- Columbia University Medical Center — New York
- Hematology Oncology Associates of Rockland — Nyack
- Albert Einstein Cancer Center — The Bronx
Beijing Municipality
- Cancer Hospital, Chinese Academy of Medical Sciences — Beijing
- The Hospital Affiliated Academy Military Medical Science, Chinese People's Liberation Army — Beijing
- Chinese People's Liberation Army General Hospital — Beijing
Arkansas
- Highlands Oncology Group — Fayetteville
California
- City of Hope National Medical Center — Duarte
New Hampshire
- Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center — Lebanon
North Carolina
- Carolinas Hematology-Oncology Associates — Charlotte
Pennsylvania
- Fox Chase Cancer Center — Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2008-04-29 |
| Est. Completion | 2018-06-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00706030
The ClinicalTrials.gov registry entry for NCT00706030 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 92 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 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions — of which vinorelbine 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: NCT00706030 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Other, New York, 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 NCT00706030 about?
NCT00706030 is a clinical study titled "Study Evaluating Neratinib (HKI-272) In Combination With Vinorelbine In Subjects With Solid Tumors And Metastatic Breast Cancer". The purpose of this study is to identify the highest tolerable dose of neratinib (HKI-272) in combination with vinorelbine and to assess the safety of the combination of the two drugs as well as to obtain preliminary information on whether the combination of the two drugs has any effect on solid tum...
What is the current status of trial NCT00706030?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 92 participants. The study started on 2008-04-29. Estimated completion is 2018-06-07.
What conditions does trial NCT00706030 study?
This clinical trial studies the following conditions: Breast Cancer, Advanced Malignant Solid Tumors. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00706030?
The interventions under investigation include: vinorelbine (DRUG), neratinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00706030?
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 NCT00706030 being conducted?
This trial has 20 study locations across Arkansas, California, New Hampshire, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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