NCT00047489

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2002

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 9, 2002

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2002

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
Last Updated

October 31, 2018

Status Verified

October 1, 2018

Enrollment Period

2.1 years

First QC Date

October 8, 2002

Last Update Submit

October 30, 2018

Conditions

Hematological Malignancies

Interventions

ABT-751DRUG

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

ABT751

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Francis J. Giles, MD

    UT MD Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2002

First Posted

October 9, 2002

Study Start

December 1, 2002

Primary Completion

January 1, 2005

Study Completion

January 1, 2005

Last Updated

October 31, 2018

Record last verified: 2018-10

Locations

US(1)