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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)

Information source: Novartis
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Myeloid Leukemia (CML)

Intervention: Imatinib (Drug); Acetaminophen (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis, Study Chair, Affiliation: Novartis

Overall contact:
Novartis U.S., Phone: 862 778 8300

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)

Clinical Details

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 design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study

Primary outcome:

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

To investigate the pharmacokinetic characteristics of imatinib at steady state in CML-CP patients following

400 mg dosing co-administered with acetaminophen

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

Novartis U.S., Phone: 862 778 8300

Novartis Investigative Site, Seoul, Korea, Republic of; Recruiting
Additional Information

Starting date: November 2006
Last updated: July 18, 2008

Page last updated: February 12, 2009

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