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NCT00508807 · ClinicalTrials.gov registry record · Phase 1
RTA 402 in Advanced Solid Tumors or Lymphoid Malignancies
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT00508807: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00508807 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 21 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00508807, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
Primary: * To determine the dose-limiting toxicity, maximum tolerated dose, and recommended phase II dose of RTA 402 capsules in patients with advanced solid tumors or lymphoid malignancies who have failed standard-of-care curative or survival-prolonging therapy, or for whom no such therapies exist. * To characterize the pharmacokinetics of RTA 402 capsules administered orally for 21 days in this patient population. Secondary: * To document any preliminary antitumor activity of RTA 402 in this patient population. * To determine the in vivo molecular and biological effects of RTA 402 by measuring changes in markers of differentiation, apoptosis, and anti-inflammatory effects in WBCs, blood plasma, and, in consenting patients, tumor biopsies. * To correlate the biological activity of RTA 402 with drug concentration in plasma and blood cellular elements * To evaluate the series of inflammation related symptoms over the course of the study, and to determine the correlation of symptom intensity with plasma cytokines.
Interventions
- DRUG RTA 402
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2006-04 |
| Est. Completion | 2009-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00508807
The ClinicalTrials.gov registry entry for NCT00508807 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which RTA 402 is the first listed.
NCT00508807 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00508807 about?
NCT00508807 is a clinical study titled "RTA 402 in Advanced Solid Tumors or Lymphoid Malignancies". Primary: * To determine the dose-limiting toxicity, maximum tolerated dose, and recommended phase II dose of RTA 402 capsules in patients with advanced solid tumors or lymphoid malignancies who have failed standard-of-care curative or survival-prolonging therapy, or for whom no such therapies exist...
What is the current status of trial NCT00508807?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2006-04. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00508807?
The interventions under investigation include: RTA 402 (DRUG).
Who is sponsoring clinical trial NCT00508807?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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