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Sponsored by: |
ChemGenex Pharmaceuticals |
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Information provided by: | ChemGenex Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00675350 |
PK Study of Homoharringtonine (Omacetaxine Mepesuccinate) Administered Subcutaneously to Patients With Advanced Solid and Hematologic Tumors
Condition | Intervention |
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Hematologic Tumors |
Drug: Omacetaxine |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
Official Title: | A Pharmacokinetic Study of Homoharringtonine (Omacetaxine Mepesuccinate) Administered Subcutaneously to Patients With Advanced Solid and Hematologic Tumors |
Estimated Enrollment: | 12 |
Study Start Date: | April 2008 |
Study Completion Date: | January 2009 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
This is an open-label non-randomized pharmacokinetic (PK) study of Homoharringtonine (Omacetaxine Mepesuccinate) administered as a subcutaneous (SC)injection to patients with relapsed and/or refractory hematologic malignancies and to patients with advanced solid tumors with no bone marrow involvement.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Be diagnosed with relapsed or refractory leukemia including chronic myelogenous leukemia (CML), acute promyelocytic leukemia (APL), acute myelogenous leukemia (AML), or myelodysplastic syndrome (MDS)
A non-fertile female is defined as:
Exclusion Criteria:
United States, Texas | |
Mary Crowley Cancer Research Center | |
Dallas, Texas, United States, 75201 |
Principal Investigator: | John Nemunaitis, M.D. | Mary Crowley Cancer Research Center |
Responsible Party: | ChemGenex Pharmaceuticals ( Adam R Craig, MD, PhD, Sr. VP and CMO ) |
Study ID Numbers: | CGX-635-205 |
Study First Received: | May 7, 2008 |
Last Updated: | March 31, 2009 |
ClinicalTrials.gov Identifier: | NCT00675350 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Omacetaxine Homoharringtonine HHT Solid and hematologic malignant tumors |
Homoharringtonine Antineoplastic Agents, Phytogenic Angiogenesis Inhibitors Harringtonines |
Antineoplastic Agents Therapeutic Uses Growth Substances Homoharringtonine Physiological Effects of Drugs Growth Inhibitors |
Angiogenesis Modulating Agents Antineoplastic Agents, Phytogenic Angiogenesis Inhibitors Harringtonines Pharmacologic Actions |