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| Sponsor: | Array BioPharma |
|---|---|
| Information provided by: | Array BioPharma |
| ClinicalTrials.gov Identifier: | NCT00916227 |
Purpose
This is a dose-escalation study to determine the maximum tolerated dose (MTD) of ARRY-614 in patients with Myelodysplastic Syndrome (MDS).
| Condition | Intervention | Phase |
|---|---|---|
|
Myelodysplastic Syndrome |
Drug: ARRY-614 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment |
| Official Title: | A Phase 1 Study of Oral ARRY-614 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome |
| Estimated Enrollment: | 50 |
| Study Start Date: | June 2009 |
| Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Study drug: Experimental
Escalating doses
|
Drug: ARRY-614 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Florida | |
| Moffitt Cancer Center | Recruiting |
| Tampa, Florida, United States, 33612 | |
| Contact: Michelle Burton, RN, BSN 813-745-3965 burtonmk@moffitt.org | |
| Principal Investigator: Rami Komrokji, MD | |
| United States, Georgia | |
| Winship Cancer Institute | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Mersiha Torlak 404-778-4582 | |
| Principal Investigator: H. Jean Khoury, MD | |
| United States, Texas | |
| MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Maria Cielo Foudray 713-563-1364 mcfoudra@mdanderson.org | |
| Principal Investigator: Guillermo Garcia-Manero, MD | |
More Information
| Responsible Party: | Array BioPharma Inc. ( Diane Nemchak, Executive Assistant ) |
| Study ID Numbers: | ARRAY-614-111 |
| Study First Received: | June 3, 2009 |
| Last Updated: | January 19, 2010 |
| ClinicalTrials.gov Identifier: | NCT00916227 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Low or Intermediate-1 Risk Myelodysplastic Syndrome |
|
Neoplasms Preleukemia Pathologic Processes Disease Precancerous Conditions |
Hematologic Diseases Syndrome Myelodysplastic Syndromes Bone Marrow Diseases |