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Sponsored by: |
Ambit Biosciences Corporation |
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Information provided by: | Ambit Biosciences Corporation |
ClinicalTrials.gov Identifier: | NCT00462761 |
Patients will receive oral AC220 daily for 14 days to study the side effects, tolerability and best dose for treating relapsed or refractory acute myeloid leukemia, regardless of FLT3 status.
Condition | Intervention | Phase |
---|---|---|
Acute Myeloid Leukemia Leukemia Myelodysplastic Syndrome AML MDS |
Drug: AC220 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I Open-Label, Sequential Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AC220 When Administered Daily to Patients With Relapsed or Refractory Acute Myeloid Leukemia |
Estimated Enrollment: | 20 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | December 2007 |
This is a multi-center clinical study conducted in the USA and possibly two international sites. It is open-label, dose escalation study designed to characterize the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of orally administered AC220 as a single agent given daily for 14 days. Cohorts of 3 patients receive AC220 until dose limiting toxicity is noted (DLT). At that point cohorts will expand to 6 patients until MTD is determined. Patients not experiencing DLT or significant disease progression at Day 15 may continue receiving AC220 at the discretion of the Investigator and Sponsor. FLT3 positive and negative patients are allowed to participate.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Histopathologically documented primary or secondary AML, as defined by WHO criteria (Jaffe et al, 2001), confirmed by pathology review at treating institution, meeting at least one of the following:
Exclusion Criteria:
Contact: Ambit Clinical Research & Development | 858-334-2173 | cp0001@ambitbio.com |
Contact: Secondary Ambit Contact | 858-334-2100 |
United States, Alabama | |
University of Alabama at Birmingham | Recruiting |
Birmingham, Alabama, United States, 35294 | |
Principal Investigator: James M Foran, MD FRCP(C) | |
United States, Nebraska | |
University of Nebraska Medical Center | Recruiting |
Omaha, Nebraska, United States, 68198 | |
Principal Investigator: Marcel P Devetten, MD | |
United States, Texas | |
MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Jorge Cortes, MD | |
Georgia | |
Hematology and Chemotherapy Clinic | Recruiting |
T'bilisi, Georgia | |
Principal Investigator: Mamia Zodelava, MD PhD | |
Chemotherapy and Immunotherapy Clinic | Recruiting |
T'Bilisi, Georgia | |
Principal Investigator: Darejan Ghirdaladze, MD PhD |
Study ID Numbers: | CP0001 |
Study First Received: | April 17, 2007 |
Last Updated: | September 24, 2007 |
ClinicalTrials.gov Identifier: | NCT00462761 |
Health Authority: | United States: Food and Drug Administration |
RTK kinase inhibitor tyrosine acute FLT3 AC220 pharmacokinetic pharmacokinetics PK pharmacodynamic pharmacodynamics mutations PD mutations |
receptor class III relapsed refractory t(8;21) q22;q22 AML1/ETO t(16;16 p13;q22 CBFbeta/MYH11 inv(16) p13q22 11q23 dysplasia myeloid |
Myelodysplastic syndromes Myelofibrosis Precancerous Conditions Hematologic Diseases Myelodysplastic Syndromes Myelodysplasia Acute myelogenous leukemia Leukemia, Myeloid Di Guglielmo's syndrome |
Leukemia, Myeloid, Acute Myeloid Metaplasia Leukemia Preleukemia Leukemia, Erythroblastic, Acute Acute erythroblastic leukemia Bone Marrow Diseases Acute myelocytic leukemia |
Neoplasms Pathologic Processes Disease Neoplasms by Histologic Type Syndrome |