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Study Evaluating the Safety and Tolerability of L-377202

NCT00987753 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2023-05-25

No results posted yet for this study

Summary

The primary purpose of this study is to (1) determine the maximally tolerated dose (MTD) of L-377202 administered once every 3 weeks, (2) evaluate the safety and tolerability of L-377202 including the dose-limiting adverse effects of treatment with L-377202, and (3) assess the pharmacokinetics of various doses of L-377202 and the plasma profile of liberated doxorubicin and leu-doxorubicin.

Conditions

Interventions

DRUG

L-377202

For each cycle, L-377202 will be administered as a 30-minute infusion every 3 weeks. The starting dose will be 20 mg/m2/week. Doses will be doubled until a patient experiences a greater than or equal to Grade 2 toxicity.

Sponsors & Collaborators

Principal Investigators

  • John Rinehart, M.D. · University of Alabama at Birmingham (no longer employee)

  • Scot Ebbinghaus, M.D. · University of Alabama at Birmingham (no longer employee)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-03-31
Primary Completion
2000-09-30
Completion
2001-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00987753 on ClinicalTrials.gov