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NCT00700336 · ClinicalTrials.gov registry record · Phase 1
Study of CBP501 + Pemetrexed + Cisplatin on MPM (Phase I/II)
A Phase 1 study, sponsored by CanBas Co..
- Completed
- Registry status
- Phase 1
- Development phase
- 69
- Enrollment target
NCT00700336 is a Phase 1 study that has completed, run by CanBas Co.. The registered enrollment target is 69 participants.
The verdict
NCT00700336, a Phase 1 study, has completed, sponsored by CanBas Co..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 69 participants
- Enrollment target
Study Summary
The phase I part of the study is a dose-finding study of escalating doses of CBP501 combined with full-dose cisplatin and pemetrexed in patients with histologically confirmed solid malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective or would otherwise be eligible for cisplatin and pemetrexed as first-line therapy. The maximum tolerated dose (MTD) will be determined based on DLTs occurring during the first treatment cycle. Pharmacokinetics of the triplet combination will be assessed during the phase I part of the trial. The phase II part will evaluate full-dose cisplatin and pemetrexed combined with CBP501 (at the MTD determined in the phase I part) in previously untreated, unresectable malignant pleural mesothelioma patients. Patients will be randomized in a 2 : 1 ratio to pemetrexed, cisplatin and CBP501 (Arm A) or to pemetrexed and cisplatin (Arm B); randomization will be stratified according to histology and performance status.
Interventions
- DRUG pemetrexed, cisplatin and CBP501
- DRUG pemetrexed and cisplatin
- DRUG pemetrexed, cisplatin and CBP501, dose finding
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2008-05 |
| Est. Completion | 2012-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00700336
The ClinicalTrials.gov registry entry for NCT00700336 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CanBas Co., which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which pemetrexed, cisplatin and CBP501 is the first listed.
NCT00700336 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00700336 about?
NCT00700336 is a clinical study titled "Study of CBP501 + Pemetrexed + Cisplatin on MPM (Phase I/II)". The phase I part of the study is a dose-finding study of escalating doses of CBP501 combined with full-dose cisplatin and pemetrexed in patients with histologically confirmed solid malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or ar...
What is the current status of trial NCT00700336?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 69 participants. The study started on 2008-05. Estimated completion is 2012-11.
What interventions are being tested in trial NCT00700336?
The interventions under investigation include: pemetrexed, cisplatin and CBP501 (DRUG), pemetrexed and cisplatin (DRUG), pemetrexed, cisplatin and CBP501, dose finding (DRUG).
Who is sponsoring clinical trial NCT00700336?
This trial is sponsored by CanBas Co., which has 5 total clinical trials registered on ClinicalTrials.gov.
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