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Study of AR-67 (Formerly DB-67) in Adult Patients With Refractory or Metastatic Solid Malignancies

NCT00389480 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2009-08-11

No results posted yet for this study

Summary

Hypothesis:

AR-67 (formerly DB-67) represents a rationally engineered drug that possesses improved stability, toxicity, and efficacy compared to current Food and Drug Administration (FDA)-approved camptothecins, based on the extensive research of prior studies. Therefore, the investigators hypothesize that AR-67 (formerly DB-67) will be well-tolerated and efficacious in phase I clinical trials. This initial phase I trial will establish the maximum tolerated dose in humans, establish the toxicity profile, and define the appropriate dose of AR-67 (formerly DB-67) for future phase II and III clinical trials.

Conditions

  • Tumors

Interventions

DRUG

AR-67 (formerly DB-67)

infusion daily x 5 days, every 21 days

Sponsors & Collaborators

  • University of Kentucky

    collaborator OTHER

  • Arch Medical Services Inc., DBA The Center for Cancer Care and Research

    collaborator INDUSTRY

  • Arno Therapeutics

    lead INDUSTRY

Principal Investigators

  • Susanne Arnold, MD · University of Kentucky

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2009-02-28
Completion
2009-05-31

Countries

  • United States

Study Locations

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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 NCT00389480 on ClinicalTrials.gov