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)

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00428909

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Nov 1, 2006

Actual Primary Completion Date :

Aug 1, 2008

Actual Study Completion Date :

Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Other: Drug-Drug interaction	Drug: Imatinib/Acetaminophen

Arm

Intervention/Treatment

Other: Drug-Drug interaction

Drug: Imatinib/Acetaminophen

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.