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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00428909 |
A non-randomized, open-label study to investigate the effects of imatinib mesylate on the pharmacokinetics of acetaminophen/paracetamol in patients with newly diagnosed, previously untreated chronic myeloid leukemia in chronic phase (CML-CP)
Condition | Intervention | Phase |
---|---|---|
Chronic Myeloid Leukemia (CML) |
Drug: Imatinib Drug: Acetaminophen |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
Official Title: | A Non-Randomized, Open-Label Study to Investigate the Effects of Imatinib Mesylate on the Pharmacokinetics of Acetaminophen/Paracetamol in Patients With Newly Diagnosed, Previously Untreated Chronic Myeloid Leukemia in Chronic Phase (CML-CP) |
Estimated Enrollment: | 25 |
Study Start Date: | November 2006 |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria
Exclusion criteria
Other protocol-defined inclusion/exclusion criteria may apply
Contact: Novartis U.S. | 862 778 8300 | |
Contact: Novartis Basel | 41 61 324 1111 |
Korea, Republic of | |
Novartis Investigative Site | Recruiting |
Seoul, Korea, Republic of |
Study Chair: | Novartis | Novartis |
Study ID Numbers: | CSTI571A2107 |
Study First Received: | January 29, 2007 |
Last Updated: | July 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00428909 |
Health Authority: | United States: Food and Drug Administration; Korea: Food and Drug Administration |
Pharmacokinetic STI571 imatinib CML |
Chronic Myeloid Leukemia Philadelphia Chromosome acetaminophen |
Imatinib Philadelphia Chromosome Leukemia Chronic myelogenous leukemia Hematologic Diseases |
Myeloproliferative Disorders Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Bone Marrow Diseases Acetaminophen |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |
Neoplasms Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents |