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NCT00037609 · ClinicalTrials.gov registry record · Phase 1
Safety, Efficacy and Pharmacokinetic Between Capecitabine and Exisulind in Metastatic Breast Cancer Patients
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
NCT00037609: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00037609 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 35 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00037609, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
Study Summary
The primary objective of the phase I study is to determine a safe dose for combination therapy with capecitabine and exisulind. A secondary objective is to assess pharmacokinetic interactions between the two drugs and assess the biological activity of exisulind. The primary objective of the Phase II part of this study is to assess the anti-tumor activity of this combination therapy measured by objective tumor response. Secondary end points also assessed will be toxicity of therapy, duration of response and time to progression.
Interventions
- DRUG Capecitabine
- DRUG Exisulind
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2001-01 |
| Est. Completion | 2003-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00037609
The ClinicalTrials.gov registry entry for NCT00037609 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Capecitabine is the first listed.
NCT00037609 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00037609 about?
NCT00037609 is a clinical study titled "Safety, Efficacy and Pharmacokinetic Between Capecitabine and Exisulind in Metastatic Breast Cancer Patients". The primary objective of the phase I study is to determine a safe dose for combination therapy with capecitabine and exisulind. A secondary objective is to assess pharmacokinetic interactions between the two drugs and assess the biological activity of exisulind. The primary objective of the Phase I...
What is the current status of trial NCT00037609?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2001-01. Estimated completion is 2003-02.
What interventions are being tested in trial NCT00037609?
The interventions under investigation include: Capecitabine (DRUG), Exisulind (DRUG).
Who is sponsoring clinical trial NCT00037609?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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