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


Phase 1
17 Years
N/A
Not Enrolling
Both
Hematological Malignancies

Thank you

Trial Information

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


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.

Inclusion Criteria


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
- Serum direct bilirubin serum creatinine
- 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Francis J. Giles, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

DM01-646

NCT ID:

NCT00047489

Start Date:

December 2002

Completion Date:

January 2005

Related Keywords:

  • Hematological Malignancies
  • Neoplasms
  • Hematologic Neoplasms

Name

Location
The University of Texas M.D. Anderson Cancer Center Houston, Texas