Study of ABT-751 in Patients With Refractory Hematologic Malignancies

October 30, 2018 updated by: M.D. Anderson Cancer Center

A Phase I Study of ABT-751 in Patients With Refractory Hematologic Malignancies

ABT-751 is a new antitumor drug that that interferes with cell division. The goal of this clinical research study is to find the highest safe dose of ABT-751 that can be given as a treatment for refractory hematologic malignancies. The safety and side effects of ABT-751 will also be studied.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The current low cure rates in most patients with advanced hematologic cancers indicate the need to identify new agents that can be incorporated with current therapies to improve prognosis. The vinca alkaloids are effective broad-spectrum anti-leukemic drugs. Microtubules are a major structural component of cells. They play a role in cell shape, cellular polarity, cellular movement, intracellular transport and the segregation of chromosomes during mitosis. The cellular microtubule dynamics are highly regulated. As cells enter mitosis, the interphase microtubules disappear and are replaced with a new network of microtubules that interact with the mitotic spindle. Disruption of these new microtubules leads to cell cycle arrest. These important and highly labile microtubule arrays comprising the mitotic spindle are the principal target of oncologic antimitotic compounds. Known antimitotic agents fall into three classes, the vinca alkaloids (vincristine, vinblastine, and vinorelbine), taxanes (paclitaxel and docetaxel), and colchicine-site binders. There are no colchicine-site agents currently approved for cancer chemotherapy. These three classes of compounds have distinct binding sites on the tubulin subunits. ABT-751 is a novel orally administered antimitotic agent that binds to the colchicine site on beta-tubulin and inhibits polymerization of microtubules.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas M.D. Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Patients with relapsed or refractory acute leukemias (AML, ALL, MDS [RAEB, RAEBT], CMML in transformation with >/= 10% peripheral blood/bone marrow blasts, CML in blast crisis), and patients with relapsed/refractory or transformed CLL.
  • Signed informed consent indicating that patients are aware of the investigational nature of this study, and in keeping with the policies of this hospital.
  • ECOG performance status </= 2.
  • Serum direct bilirubin </= 2 mg/dL, serum SGOT or SGPT < 3 upper limit of normal, serum creatinine </= 2 mg/dL, unless considered due to organ leukemic involvement.
  • Age > 16 years - a separate Phase I study is being conducted in the pediatric population.

Exclusion Criteria

  • Any severe, concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for study entry.
  • Pregnant and/or lactating females.
  • Those with documented sulfonamide allergy should be excluded from study participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Francis J. Giles, MD, UT MD Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Primary Completion (Actual)

January 1, 2005

Study Completion (Actual)

January 1, 2005

Study Registration Dates

First Submitted

October 8, 2002

First Submitted That Met QC Criteria

October 8, 2002

First Posted (Estimate)

October 9, 2002

Study Record Updates

Last Update Posted (Actual)

October 31, 2018

Last Update Submitted That Met QC Criteria

October 30, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DM01-646

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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