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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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 21 participants
Start Date 2006-04
Est. Completion 2009-12
Phase Phase 1
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT00508807 record still lists

NCT00508807 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).

The record links to 0 conditions, and to 1 intervention - of which RTA 402 is the first listed.

NCT00508807 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00508807's enrollment target sits among peer trials

21 1615th of 2000 higher than 372 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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Source: ClinicalTrials.gov NCT00508807, the US trial registry maintained by the National Library of Medicine. NCT00508807 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.