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)

Chronic Myeloid Leukemia (CML) Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00428909
• Other study ID #: CSTI571A2107
• Status: Completed
• Phase: Phase 1
• First received: January 29, 2007
• Last updated: April 20, 2016
• Start date: November 2006
• Est. completion date: August 2008

Study information

• Verified date: April 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationKorea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia (CML)
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

Drug:
• Imatinib/Acetaminophen

Locations

Country	Name	City	State
Korea, Republic of	Novartis Investigative Site	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate the effects of the co-administration of imatinib on the pharmacokinetics of acetaminophen / paracetamol		Day 1, day 2 -7, Day 8	No
Primary	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	No