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| Sponsor: | Ambit Biosciences Corporation |
|---|---|
| Information provided by: | Ambit Biosciences Corporation |
| ClinicalTrials.gov Identifier: | NCT00462761 |
Purpose
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: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| 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:
Contacts and Locations| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Nebraska | |
| University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198 | |
| United States, Texas | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Georgia | |
| Hematology and Chemotherapy Clinic | |
| T'bilisi, Georgia | |
| Chemotherapy and Immunotherapy Clinic | |
| T'Bilisi, Georgia | |
| Study Director: | Guy Gammon, MB BS, MRCP | Interim Chief Medical Officer, Ambit Biosciences Corporation |
More Information
| Responsible Party: | Guy Gammon, MB BS, MRCP, Interim Chief Medical Officer, Ambit Biosciences Corporation |
| ClinicalTrials.gov Identifier: | NCT00462761 History of Changes |
| Other Study ID Numbers: | CP0001 |
| Study First Received: | April 17, 2007 |
| Last Updated: | June 30, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
RTK kinase inhibitor tyrosine acute FLT3 AC220 pharmacokinetic pharmacokinetics PK pharmacodynamic pharmacodynamics mutations PD 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 myelomonocytic |
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Myelodysplastic Syndromes Preleukemia |
Neoplasms by Histologic Type Neoplasms Bone Marrow Diseases Hematologic Diseases Precancerous Conditions |