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NCT00322140 · ClinicalTrials.gov registry record · Phase 1
CDDO to Treat Solid Tumors and Lymphomas
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT00322140: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00322140 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 7 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00322140, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
Background: * CDDO is a novel synthetic triterpenoid which is a potent multifunctional molecule. It induces apoptosis in vitro in malignant cells through both intrinsic and extrinsic pathways, and it controls cellular differentiation, apoptosis, and growth inhibition by serving as a ligand for the transcription factor peroxisome proliferator activator receptor-gamma (PPAR gamma). * Based on in vitro activity, it holds considerable promise as a novel anti-tumor agent against a wide range of malignancies by concurrently targeting multiple pathways leading to oncogenesis. * In vivo data demonstrates that the drug is well tolerated in dogs, and has anti-tumor effects, dependent upon dose schedule. Objectives: Primary: * To determine the dose limiting toxicities, toxicity profile, and maximum tolerated dose of CDDO when administered in adult patients with solid tumors and lymphomas. * To characterize the pharmacokinetics of CDDO. Secondary: * To obtain preliminary evidence of anti-tumor activity of CDDO in this population. * To evaluate the in vivo molecular and biological effects of CDDO by assessing changes in biomarkers of apoptosis and cell cycle arrest. Eligibility: * Patients with advance, histological-confirmed malignancies refractory to standard therapy or for which no standard therapy exist. * Patients should have adequate liver, renal and bone marrow function. Study Design: * Accordingly with the accelerated titration design 4B, dose levels will initially be increased at 100% increments, and one new patient per dose level will be treated per 4-week course. * The accelerated phase ends when one patient experiences DLT during any course of treatment or when two different patients experience grade 2 toxicity during first course of treatment. * When the first instance of grade 2 toxicity is observed two additional patients must have been treated at that dose, or a higher dose, (during any course) without experiencing moderate or worse toxicity, in order t
Interventions
- DRUG CDDO
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2006-05-01 |
| Est. Completion | 2008-01-14 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00322140
The ClinicalTrials.gov registry entry for NCT00322140 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CDDO is the first listed.
NCT00322140 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00322140 about?
NCT00322140 is a clinical study titled "CDDO to Treat Solid Tumors and Lymphomas". Background: * CDDO is a novel synthetic triterpenoid which is a potent multifunctional molecule. It induces apoptosis in vitro in malignant cells through both intrinsic and extrinsic pathways, and it controls cellular differentiation, apoptosis, and growth inhibition by serving as a ligand for the ...
What is the current status of trial NCT00322140?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2006-05-01. Estimated completion is 2008-01-14.
What interventions are being tested in trial NCT00322140?
The interventions under investigation include: CDDO (DRUG).
Who is sponsoring clinical trial NCT00322140?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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