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| Sponsor: | EntreMed |
|---|---|
| Information provided by: | EntreMed |
| ClinicalTrials.gov Identifier: | NCT00506402 |
Purpose
The main objectives of this study are to evaluate the side effects of MKC-1 and to determine a safe dose of MKC-1 for future studies in patients with hematological malignancies
| Condition | Intervention | Phase |
|---|---|---|
|
Hematological Malignancies Myelodysplasia Agnogenic Myeloid Metaplasia |
Drug: MKC-1 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase 1 Study of MKC-1 in Patients With Refractory Hematologic Malignancies |
| Estimated Enrollment: | 30 |
| Study Start Date: | November 2006 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: MKC-1
Capsule, 30 mg and 100 mg, BID, continuous dosing
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The following laboratory results, within 10 days of MKC-1 administration (unless the abnormality is considered attributable to leukemia):
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | EntreMed, Inc. ( Chief Medical Officer ) |
| Study ID Numbers: | MKC-104 |
| Study First Received: | July 24, 2007 |
| Last Updated: | May 4, 2009 |
| ClinicalTrials.gov Identifier: | NCT00506402 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
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Adult patients with refractory leukemias, MDS or AMM |
|
Myelofibrosis Precancerous Conditions Hematologic Neoplasms Hematologic Diseases Myelodysplastic Syndromes Myeloproliferative Disorders Myeloid Metaplasia Lymphatic Diseases |
Neoplasms Preleukemia Neoplasms by Site Pathologic Processes Metaplasia Bone Marrow Diseases Splenic Diseases |