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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Concordia Pharmaceuticals, Inc |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00867230 |
Primary Objective:
1. Determining the maximum tolerated dose (MTD) and pharmacokinetics (PK) of FTS (S-Trans, Trans-Farnesylthiosalicylic Acid) after daily oral administration on Days 1 through 21 of a 28-Day cycle to patients with advanced hematologic malignancies that have progressed following effective therapy or for which no effective therapy exists.
Condition | Intervention | Phase |
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Myelodysplastic Syndrome Leukemia |
Drug: FTS |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Open-Label Study of S-Trans, Trans-Farnesylthiosalicylic Acid (FTS) Administered on Days 1 to 21 of a 28 Day Cycle in Patients With Advanced Hematologic Malignancies |
Enrollment: | 18 |
Study Start Date: | May 2006 |
Study Completion Date: | February 2009 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
FTS (S-trans, trans-farnesylthiosalicylic acid)
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Drug: FTS
Starting dose of 100 mg twice a day by mouth, Days 1 through 21 of a 28-day cycle.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
U.T.M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Gautam Borthakur, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | UT MD Anderson Cancer Center ( Gautam Borthakur, MBBS / Assistant Professor ) |
Study ID Numbers: | 2006-0201 |
Study First Received: | March 20, 2009 |
Last Updated: | March 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00867230 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Myelodysplastic Syndrome Chronic Myelomonocytic Leukemia Acute Myeloid Leukemia Acute Lymphocytic Leukemia Chronic Lymphocytic Leukemia |
Chronic Myelogenous Leukemia Agnogenic Myeloid Metaplasia FTS S-Trans, Trans-Farnesylthiosalicylic Acid |
Chronic Myelomonocytic Leukemia Leukemia, Lymphoid Myelofibrosis Precursor Cell Lymphoblastic Leukemia-Lymphoma Precancerous Conditions Hematologic Neoplasms Hematologic Diseases Leukemia, Myelomonocytic, Chronic Farnesylthiosalicylic acid Myelodysplastic Syndromes Leukemia, Myeloid Leukemia, Myeloid, Acute |
Myeloid Metaplasia Leukemia Chronic Lymphocytic Leukemia Acute Myelocytic Leukemia Preleukemia Leukemia, Lymphocytic, Chronic, B-Cell Metaplasia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Chronic Myelogenous Leukemia Leukemia, B-cell, Chronic Bone Marrow Diseases Acute Lymphoblastic Leukemia |
Neoplasms by Histologic Type Disease Molecular Mechanisms of Pharmacological Action Hematologic Neoplasms Precancerous Conditions Antineoplastic Agents Hematologic Diseases Farnesylthiosalicylic acid Myelodysplastic Syndromes Enzyme Inhibitors |
Pharmacologic Actions Leukemia Preleukemia Neoplasms Pathologic Processes Neoplasms by Site Therapeutic Uses Syndrome Bone Marrow Diseases |