AG-013736 (Axitinib) In Patients With Poor Prognosis Acute Myeloid Leukemia (AML) Or Myelodysplastic Syndrome (MDS)

NCT ID: NCT00071006

Last Updated: 2012-06-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2004-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study tests the safety and efficacy of axitinib in patients who have the hematologic disease of Acute Myeloid Leukemia or Myelodysplastic Syndrome. The study tests patients who have poor prognosis before entering the study.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Myeloid Leukemia (AML) Myelodysplastic Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Single arm study

Group Type EXPERIMENTAL

AG-013736 (Axitinib)

Intervention Type DRUG

patients were treated with axitinib at starting dose of 5 mg BID continuous dosing.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AG-013736 (Axitinib)

patients were treated with axitinib at starting dose of 5 mg BID continuous dosing.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Poor prognosis AML or MDS
* Histological confirmation of diagnosis
* White blood cell count less than or equal to 30,000/mm3
* Adequate hepatic and renal function documented within 14 days prior to registration
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* No evidence of preexisting uncontrolled hypertension
* Not a suitable candidate for chemotherapy
* No prior systemic chemotherapy treatment for AML or MDS or treatment with an anti-angiogenesis agent

Exclusion Criteria

* Candidate for chemotherapy
* Patients with AML M3 (acute promyelocytic leukemia)
* Conditions that might confound the evaluation of safety or efficacy or increase patient risk.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pfizer Investigational Site

Houston, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A4061013

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Phase 1-2 Study of Low Dose ASTX727 (ASTX727 LD) in Lower Risk MDS
NCT03502668 ACTIVE_NOT_RECRUITING PHASE1/PHASE2