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NCT00402766 · ClinicalTrials.gov registry record · Phase 1
Cisplatin, Pemetrexed, and Imatinib Mesylate in Malignant Mesothelioma
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT00402766: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00402766 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00402766, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
Primary Objective: * To determine the maximum tolerated dose of the combination of cisplatin, imatinib mesylate, and pemetrexed in metastatic malignant mesothelioma. Secondary Objectives: * To explore the biologic effects of cisplatin, imatinib mesylate, and pemetrexed on tumor tissue by: * histologic analysis of biopsy tissue * by non-invasive assessments of tumor vascularity performed before, during and after treatment * electron microscopy analysis of endothelial cell architecture after patient treatment with imatinib mesylate * To explore the effects of cisplatin, imatinib mesylate, and pemetrexed on surrogate markers in serum. * To assess the rate of response to therapy. * To determine the doses of the combination regimen of cisplatin, imatinib mesylate, and pemetrexed that enables de-phosphorylation of platelet derived growth factor receptor (PDGF-R) on malignant mesothelioma tumor cells. * To determine the pharmacokinetic interaction between agents in this combination regimen.
Primary Outcome
MTD defined as the highest dose level in which 6 patients have been treated with less than or equal to 2 instances of dose limiting toxicity (DLT). DLT characterized by the National Cancer Institute (NCI) Common Toxicity Criteria. DLT defined as (1) febrile neutropenia (fever \> grade 2 with grade 4 neutropenia and requiring IV antibiotics); (2) grade 4 neutropenia (ANC \< 500/mL) for more than seven days duration; (3) grade 4 thrombocytopenia; (4) grade 3 or 4 non-hematologic toxicity (except a
Interventions
- DRUG Cisplatin
- DRUG Pemetrexed
- DRUG Dexamethasone
- DRUG Imatinib Mesylate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2006-08 |
| Est. Completion | 2014-02 |
| Phase | Phase 1 |
What the finished NCT00402766 record still lists
NCT00402766 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 4 interventions - of which Cisplatin is the first listed.
NCT00402766 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00402766 about?
NCT00402766 is a clinical study titled "Cisplatin, Pemetrexed, and Imatinib Mesylate in Malignant Mesothelioma". Primary Objective: * To determine the maximum tolerated dose of the combination of cisplatin, imatinib mesylate, and pemetrexed in metastatic malignant mesothelioma. Secondary Objectives: * To explore the biologic effects of cisplatin, imatinib mesylate, and pemetrexed on tumor tissue by: * histo...
What is the current status of trial NCT00402766?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2006-08. Estimated completion is 2014-02.
What interventions are being tested in trial NCT00402766?
The interventions under investigation include: Cisplatin (DRUG), Pemetrexed (DRUG), Dexamethasone (DRUG), Imatinib Mesylate (DRUG).
Who is sponsoring clinical trial NCT00402766?
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 NCT00402766's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 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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