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A Trial of ALB 109564(a) in Subjects With Advanced Solid Tumors

NCT00724100 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2014-08-27

No results posted yet for this study

Summary

The purpose of this study is to determine the maximum tolerated dose of ALB 109564(a), a novel tubulin inhibitor, and to assess safety, pharmacokinetics, and anti-tumor activity in subjects with advanced solid tumors.

Conditions

Interventions

DRUG

ALB 109564(a) (12´-methylthiovinblastine dihydrochloride)

Starting dose is 1.2 mg/m2. Standard dose increase, in the absence of limiting toxicity, is 50%. Each dose of ALB 109564(a) will be administered by intravenous infusion once every 3 weeks (21-day cycle) over a period of time up to approximately 30 minutes. Number of cycles: Maximum of 12, until disease progression, or unacceptable toxicity develops. Greater than 12 cycles if disease has not progressed after 12 cycles, with Investigator's and Sponsor's approvals.

Sponsors & Collaborators

  • Westat

    collaborator OTHER

  • Albany Molecular Research, Inc.

    lead INDUSTRY

Principal Investigators

  • Daniel Cho, MD · Beth Israel Deaconess Medical Center

  • Geoffrey Shapiro, MD, PhD · Dana-Farber Cancer Institute

  • Eunice L. Kwak, MD, PhD · Massachusetts General Hospital

  • Sridhar Mani, MD · Montefiore-Einstein Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00724100 on ClinicalTrials.gov