Study of Nilotinib in Ph+ CML-CP Patients With Low Imatinib Trough Plasma Concentrations

NCT ID: NCT01131325

Last Updated: 2021-05-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-21
• Study Completion Date: 2011-05-12

Brief Summary

This study is to determine the number of European Leukemia Network (ELN)guideline defined treatment failure events from time of study entry in CML-CP patients with low imatinib trough concentrations treated with nilotinib.

Conditions

CML; Philadelphia Chromosome Positive (Ph+); Chronic Myelogenous Leukemia Chronic Phase(CML-CP) Patients With Low Imatinib Trough Levels

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nilotinib

Group Type: EXPERIMENTAL

nilotinib

Intervention Type: DRUG

All patients will receive nilotinib 300mg bid po daily. Nilotinib dose is taken every 12 hours

Interventions

nilotinib

All patients will receive nilotinib 300mg bid po daily. Nilotinib dose is taken every 12 hours

Intervention Type: DRUG

Other Intervention Names

AMN107; Tasigna

Eligibility Criteria

Inclusion Criteria

• Cytogenetically confirmed Ph+ CML-CP Any prior dose of Imatinib
• Imatinib 400 mg daily for ≥7 consecutive days prior to imatinib trough collection
• Imatinib trough plasma concentration <850 ng/mL

Exclusion Criteria

• Prior documented failure events as defined by ELN guidelines:
• Loss of CHR, CCyR, or clonal progression/Ph+
• Less than CHR at 3 months after diagnosis
• No CyR at 6 months after diagnosis
• Less than PCyR at 12 months after diagnosis
• Less than CCyR at 18 months after diagnosis
• Prior accelerated phase or blast phase CML
• Previously documented T315I mutation
• Previous treatment for CML with any other tyrosine kinase inhibitor except for imatinib
• Patients who had any other treatment for CML (transplant) except interferon +/- ara- C, imatinib, hydroxyurea and/or anagrelide
• Impaired cardiac function
• Patients receiving therapy with strong inhibitors of CYP3A4 or medications that prolong the QT interval and cannot be either discontinued or switched to a different medication prior to starting study drug.
• Any other malignancy that is clinically significant or requires active intervention.
• Major surgery within 4 weeks prior to Day 1 of study or who have not recovered from prior surgery
• Treatment with other investigational agents within 30 days of Day 1
• Women who are pregnant, breast feeding, or of childbearing potential without a negative serum test at baseline. Post-menopausal women must be amenorrhoeic for at least 12 months to be considered of non-childbearing potential. Women of childbearing potential must have a negative serum pregnancy test within 7 days of the first dose of nilotinib
• Sexually active male and female patients taking nilotinib unwilling to use adequate contraception throughout the trial and 3 months following discontinuation of study drug

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Comprehensive Cancer Centers of Nevada CCC of Nevada (1)

Las Vegas, Nevada, United States

Cancer Center of the High Plains

Amarillo, Texas, United States

Baylor Health Care System/Sammons Cancer Center Dept. of Sammons Cancer (2)

Dallas, Texas, United States

Countries

United States

Other Identifiers

CAMN107AUS20

Identifier Type: -

Identifier Source: org_study_id