Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00483366 · ClinicalTrials.gov registry record · Phase 1
Imatinib Mesylate, Gemcitabine, and Capecitabine in Treating Patients With Advanced Solid Tumors
A Phase 1 study, sponsored by University of Nebraska.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT00483366: Completed Phase 1 study, sponsored by University of Nebraska.
NCT00483366 is a Phase 1 study that has completed, run by University of Nebraska. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00483366, a Phase 1 study, has completed, sponsored by University of Nebraska.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving imatinib mesylate together with gemcitabine and capecitabine may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of gemcitabine and capecitabine when given together with imatinib mesylate in treating patients with advanced solid tumors.
Primary Outcome
Cohorts of 3 starting at dose level 0. The imatinib dose is fixed. The dose of capecitabine is initially fixed and the dose of gemcitabine is increased 1 dose level. For the subsequent cohort, the dose of gemcitabine will be fixed and the dose of capecitabine advanced to the next dose level. 3 patients will be treated on the initial schedule. If no dose-limiting toxicities related to drug are observed and no patients require dose mods by the end of cycle 2, then 3 patients will be treated on the
Interventions
- GENETIC mutation analysis
- DRUG imatinib mesylate
- DRUG capecitabine
- DRUG gemcitabine hydrochloride
- GENETIC nucleic acid sequencing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2006-08-15 |
| Est. Completion | 2011-03-29 |
| Phase | Phase 1 |
What the finished NCT00483366 record still lists
NCT00483366 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 5 interventions - of which mutation analysis is the first listed.
NCT00483366 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00483366 about?
NCT00483366 is a clinical study titled "Imatinib Mesylate, Gemcitabine, and Capecitabine in Treating Patients With Advanced Solid Tumors". RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from div...
What is the current status of trial NCT00483366?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2006-08-15. Estimated completion is 2011-03-29.
What interventions are being tested in trial NCT00483366?
The interventions under investigation include: mutation analysis (GENETIC), imatinib mesylate (DRUG), capecitabine (DRUG), gemcitabine hydrochloride (DRUG), nucleic acid sequencing (GENETIC).
Who is sponsoring clinical trial NCT00483366?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00483366's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03125655 · 13 participants
Regulation of Inflammatory Genes in Psoriasis
- NCT03774446 · 13 participants · Phase 2
Multicenter Study of Seliciclib (R-roscovitine) for Cushing Disease
- NCT03830151 · 13 participants · Phase 1
Hyperpolarized Carbon C 13 Pyruvate in Diagnosing Glioma in Patients With Brain Tumors
- NCT04573231 · 13 participants · Phase 2
Evaluation of PSMA in HER2- AR+ Metastatic Breast Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI