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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00428909
First Posted: January 30, 2007
Last Update Posted: April 21, 2016
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.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
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/Acetaminophen Phase 1

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • 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 ]
  • 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 ]

Enrollment: 12
Study Start Date: November 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Drug-Drug interaction Drug: Imatinib/Acetaminophen

  Eligibility

Information from the National Library of Medicine

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

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

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00428909


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

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00428909     History of Changes
Other Study ID Numbers: CSTI571A2107
First Submitted: January 29, 2007
First Posted: January 30, 2007
Last Update Posted: April 21, 2016
Last Verified: April 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Pharmacokinetic
STI571
imatinib
CML
Chronic Myeloid Leukemia
Philadelphia Chromosome
acetaminophen

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Acetaminophen
Imatinib Mesylate
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action