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NCT00354523 · ClinicalTrials.gov registry record · Phase 1
Imatinib in Combination With Dacarbazine and Capecitabine in Medullary Thyroid Carcinoma
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT00354523: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00354523 is a Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00354523, a Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
Objectives: Primary objectives: To determine the maximum tolerated doses (MTD) for the combination of imatinib mesylate, capecitabine, and dacarbazine in patients with solid tumors. To determine the overall tumor response rate to imatinib mesylate in combination with capecitabine and dacarbazine as first line and second line therapy in advanced metastatic medullary thyroid carcinoma. To determine the tolerability (toxicity) of this regimen. Secondary objectives: To determine the median overall survival (OS) and time to progression (TTP) for patients treated with this combination.
Primary Outcome
The MTD is defined as the dose level below that producing dose limiting toxicity (DLT; i.e. any Grade 4 hematologic toxicity and /or non hematological toxicity \>/= Grade 3 in 2/6 participants).
Interventions
- DRUG Capecitabine (Xeloda)
- DRUG DTIC-Dome (Dacarbazine)
- DRUG Gleevec (Imatinib Mesylate)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2004-12 |
| Est. Completion | 2013-08 |
| Phase | Phase 1 |
Why NCT00354523 stopped before completion
NCT00354523 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 3 interventions - of which Capecitabine (Xeloda) is the first listed.
NCT00354523 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00354523 about?
NCT00354523 is a clinical study titled "Imatinib in Combination With Dacarbazine and Capecitabine in Medullary Thyroid Carcinoma". Objectives: Primary objectives: To determine the maximum tolerated doses (MTD) for the combination of imatinib mesylate, capecitabine, and dacarbazine in patients with solid tumors. To determine the overall tumor response rate to imatinib mesylate in combination with capecitabine and dacarbazine ...
What is the current status of trial NCT00354523?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2004-12. Estimated completion is 2013-08.
What interventions are being tested in trial NCT00354523?
The interventions under investigation include: Capecitabine (Xeloda) (DRUG), DTIC-Dome (Dacarbazine) (DRUG), Gleevec (Imatinib Mesylate) (DRUG).
Who is sponsoring clinical trial NCT00354523?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00354523's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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