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)

NCT00428909 | Completed Phase 1

• 1 other identifier: CSTI571A2107
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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)

Conditions

Chronic Myeloid Leukemia (CML)

Keywords

Pharmacokinetic; STI571; imatinib; CML; Chronic Myeloid Leukemia; Philadelphia Chromosome; acetaminophen

Outcome Measures

Primary Outcomes (2)

• To investigate the effects of the co-administration of imatinib on the pharmacokinetics of acetaminophen / paracetamol

  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

  Day 1, Day 2-7, Day 8

Study Arms (1)

Drug-Drug interaction

OTHER

Drug: Imatinib/Acetaminophen

Interventions

Imatinib/Acetaminophen DRUG

Drug-Drug interaction

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Seoul, South Korea

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Philadelphia Chromosome

Interventions

Imatinib Mesylate; Acetaminophen

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Translocation, Genetic; Chromosome Aberrations

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Acetanilides; Anilides; Aniline Compounds; Amines

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmeceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2007
• First Posted: January 30, 2007
• Study Start: November 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: April 21, 2016

Record last verified: 2016-04

Locations

KR (1)