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:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00428909
First received: January 29, 2007
Last updated: November 20, 2009
Last verified: November 2009
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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:

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00428909     History of Changes
Other Study ID Numbers: CSTI571A2107
Study First Received: January 29, 2007
Last Updated: November 20, 2009
Health Authority: United States: Food and Drug Administration
Korea: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 20, 2014