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Study of ABT-751 in Patients With Refractory Hematologic Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00047489
Recruitment Status : Completed
First Posted : October 9, 2002
Last Update Posted : October 31, 2018
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hematological Malignancies Drug: ABT-751 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of ABT-751 in Patients With Refractory Hematologic Malignancies
Study Start Date : December 2002
Actual Primary Completion Date : January 2005
Actual Study Completion Date : January 2005

Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00047489

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United States, Texas
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
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Principal Investigator: Francis J. Giles, MD UT MD Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00047489    
Other Study ID Numbers: DM01-646
First Posted: October 9, 2002    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases