![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsored by: |
Cephalon |
---|---|
Information provided by: | Cephalon |
ClinicalTrials.gov Identifier: | NCT00030186 |
The purpose of this study is to determine the response rate of patients with refractory, relapsed or poor risk AML expressing FLT-3 activating mutations, when administered CEP-701 at a dosage of 60 mg 2 times a day.
Condition | Intervention | Phase |
---|---|---|
Leukemia, Myeloid |
Drug: CEP-701 solution |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label Study of CEP-701 in Patients With Refractory, Relapsed, or Poor Risk Acute Myeloid Leukemia Expressing FLT-3 Activating Mutations |
Estimated Enrollment: | 37 |
Study Start Date: | January 2002 |
This is an open-label study of CEP-701 in patients with refractory, relapsed, or poor risk AML expressing FLT-3 activating mutations. Patients who meet eligibility criteria will be enrolled at a dosage of 60 mg orally 2 times a day for 28 days (1 cycle). Upon completion of cycle 1, the dosage may be increased to 80mg 2 times a day or decreased to 40 mg 2 times a day, dependent upon response to 60 mg dosage.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
United States, Maryland | |
Johns Hopkins Oncology Center, Bunting Blaustein Building | |
Baltimore, Maryland, United States, 21231 | |
United States, Texas | |
The University of Texas, M.D. Anderson Cancer Center | |
Houston, Texas, United States, 70030 |
Study ID Numbers: | C0701a/202/ON/US |
Study First Received: | February 7, 2002 |
Last Updated: | January 12, 2006 |
ClinicalTrials.gov Identifier: | NCT00030186 |
Health Authority: | United States: Food and Drug Administration |
AML FLT-3 mutation |
Leukemia Acute myelogenous leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Acute myelocytic leukemia |
Neoplasms Neoplasms by Histologic Type |