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NCT00450502 · ClinicalTrials.gov registry record · Phase 1
Safety of Batracylin in Patients With Solid Tumors and Lymphomas
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
NCT00450502: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00450502 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 33 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00450502, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
Study Summary
Background: * Batracylin advanced through the National Cancer Institute (NCI) drug development pipeline until its evaluation at Stage 3 on July 1989, It was then proposed for a phase I investigation based on its activity against as TOPO II inhibitor in s.c. mouse colon 38, PANC03, COLO9, and cisplatin- and doxorubicin-resistant P388 tumors. * IND-directed oral toxicology studies indicated interspecies variation in toxicity. Rats were found to be highly sensitive to batracylin. Ames et al showed that the interspecies variation in toxicity was consistent with the pattern of metabolism of the compound by N-acetyltransferase 2 (NAT2) to the acetylated form, N-Ac-batracylin, (a highly toxic molecule) * We hypothesize that batracylin can be administered safely in slow acetylator NAT2 genotype patients and can be rapidly evaluated for its potential as a tumor-suppressing agent. Objectives: * Define the maximum tolerated dose, dose-limiting toxicities, and toxicity profile associated with the oral administration of batracylin daily x7 consecutive days, repeated every 28 days in patients with solid tumors and lymphomas. * Define the pharmacokinetics of oral batracylin administered daily x7 consecutive days every 28 days. * Obtain preliminary evidence of anti-tumor activity of batracylin in patients with solid tumors or lymphoma. * Correlate polymorphisms in slow acetylators NAT2 genotypes (NAT2 5, NAT2 6, NAT2 7, and NAT2 14) with pharmacokinetics results. * Evaluate the inter-subject variability and toxicity ratio, (N-Ac-Batra) / (batracylin). * Evaluate the effect of batracylin treatment on gamma-H2AX levels in tumor biopsies. Eligibility: * Patients must have a slow acetylator NAT2 genotype defined as NAT2 5, NAT2 6, NAT2 7, or NAT2 14. * Patients with advanced, histologically confirmed malignancies refractory to standard therapy, or those for whom no standard therapy exists. * Patients should have adequate liver, renal, and bone marrow function. Study Design: * In
Interventions
- DRUG Batracylin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2007-02-24 |
| Est. Completion | 2011-04-24 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00450502
The ClinicalTrials.gov registry entry for NCT00450502 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 33 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 Batracylin is the first listed.
NCT00450502 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00450502 about?
NCT00450502 is a clinical study titled "Safety of Batracylin in Patients With Solid Tumors and Lymphomas". Background: * Batracylin advanced through the National Cancer Institute (NCI) drug development pipeline until its evaluation at Stage 3 on July 1989, It was then proposed for a phase I investigation based on its activity against as TOPO II inhibitor in s.c. mouse colon 38, PANC03, COLO9, and cispla...
What is the current status of trial NCT00450502?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2007-02-24. Estimated completion is 2011-04-24.
What interventions are being tested in trial NCT00450502?
The interventions under investigation include: Batracylin (DRUG).
Who is sponsoring clinical trial NCT00450502?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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