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Effect of Imatinib Mesylate and the Pharmacokinetics of Acetaminophen/Paracetamol in Patients With Newly Diagnosed, Previously Untreated Chronic Myeloid Leukemia in Chronic Phase (CML-CP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00428909
Recruitment Status : Completed
First Posted : January 30, 2007
Last Update Posted : April 21, 2016
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Myeloid Leukemia (CML) Drug: Imatinib/Acetaminophen Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : November 2006
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Arm Intervention/treatment
Drug-Drug interaction Drug: Imatinib/Acetaminophen

Primary Outcome Measures :
  1. To investigate the effects of the co-administration of imatinib on the pharmacokinetics of acetaminophen / paracetamol [ Time Frame: Day 1, day 2 -7, Day 8 ]
  2. To investigate the pharmacokinetic characteristics of imatinib at steady state in CML-CP patients following 400 mg dosing co-administered with acetaminophen [ Time Frame: Day 1, Day 2-7, Day 8 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Ability to provide written informed consent prior to participation to the study.
  • Male or female patients ≥ 18 and ≤ 75 years of age
  • Patients with CML-CP within 6 months of diagnosis (date of initial diagnosis is the date of first cytogenetic analysis). FISH analysis will not be accepted.
  • Diagnosis of CML in chronic phase with cytogenetic confirmation of Philadelphia chromosome of (9;22) translocations and presence of Bcr-Abl
  • Documented chronic phase CML as defined by:
  • < 15% blasts in peripheral blood and bone marrow
  • < 30% blasts plus promyelocytes in peripheral blood and bone marrow
  • < 20% basophils in the peripheral blood
  • ≥ 100 x 109/L (≥ 100,000 /mm3) platelets
  • No evidence of extramedullary leukemic involvement, with the exception of hepatosplenomegaly
  • Adequate end organ function as defined by:
  • total bilirubin < 1.5 x ULN
  • SGOT and SGPT < 2.5 x UNL
  • creatinine < 1.5 x ULN
  • Female patients of childbearing potential must have a negative serum pregnancy test within 7 days before initiation of study drug

Exclusion criteria:

  • Patients in late chronic phase, accelerated phase, or blastic phase are excluded
  • Patients who have received other investigational agents
  • Patients who received imatinib for any duration prior to study entry
  • Patient received any treatment for CML prior to study entry for longer than 2 weeks with the exception of hydroxyurea and/or anagrelide
  • Patients with another primary malignancy except if the other primary malignancy is neither currently clinically significant or requiring active intervention
  • Patients who are:
  • pregnant
  • breast feeding
  • of childbearing potential without a negative pregnancy test prior to baseline
  • male or female of childbearing potential unwilling to use barrier contraceptive precautions throughout the trial
  • Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential
  • Patient with a severe or uncontrolled medical condition (i.e., uncontrolled diabetes, chronic renal disease)
  • Patient previously received radiotherapy to ≥ 25% of the bone marrow
  • Patient had major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery
  • Patients with an ECOG Performance Status Score ≥ 3
  • Patients with International normalized ratio (INR) or partial thromboplastin time (PTT) > 1.5 x IULN, with the exception of patients on treatment with oral anticoagulant
  • Patients with known positivity for human immunodeficiency virus (HIV)
  • baseline testing for HIV is not required
  • Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent
  • Patients with identified sibling donors where allogeneic bone marrow transplant is elected as first line treatment
  • Patients who are chronic users of acetaminophen or medications containing acetaminophen.
  • Patients who received acetaminophen or medications containing acetaminophen within 72 hours prior to study entry.

Other protocol-defined inclusion/exclusion criteria may apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00428909

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Korea, Republic of
Novartis Investigative Site
Seoul, Korea, Republic of
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals

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Responsible Party: Novartis Pharmaceuticals Identifier: NCT00428909    
Other Study ID Numbers: CSTI571A2107
First Posted: January 30, 2007    Key Record Dates
Last Update Posted: April 21, 2016
Last Verified: April 2016
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Chronic Myeloid Leukemia
Philadelphia Chromosome
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib Mesylate
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action