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Trial record 1 of 1 for:    NCT03128411
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Study of Bosutinib in Japanese Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia

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ClinicalTrials.gov Identifier: NCT03128411
Recruitment Status : Active, not recruiting
First Posted : April 25, 2017
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE March 28, 2017
First Posted Date  ICMJE April 25, 2017
Last Update Posted Date March 21, 2019
Actual Study Start Date  ICMJE May 15, 2017
Actual Primary Completion Date March 12, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2017)
The proportion of participants with Major Molecular Response (MMR) at 12 Months [ Time Frame: 12 Months ]
MMR is defined as <0.1%Bcr-Abl1 on the International Scale (IS) by Real Time Quantitative Polymerase Chain Reaction (RT-PCR)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03128411 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2018)
  • MMR by 12 and 18 months [ Time Frame: 12 and 18 months ]
  • Complete Cytogenetic Response (CCyR) by 12 months [ Time Frame: 12 months ]
  • Duration of MMR and CCyR [ Time Frame: 5 years ]
  • Event Free Survival (EFS) [ Time Frame: 5 years ]
  • Overall Survival (OS) [ Time Frame: 5 years ]
  • Ctrough [ Time Frame: 3 months ]
    Population PK parameters (CL, V1, Q, V2, Ka) will be analized (PK time points: pre-dose on Day 1, Day 28, Day 56, Day 84).
  • Correlations between trough concentrations of bosutinib and key efficacy (e.g. MMR and CCyR) and safety (e.g. Nausea, Thrombocytopenia, Diarrhea, Vomiting, AST/ALT, total bilirubin, and QTc) endpoints [ Time Frame: 3 months ]
  • Adverse Event (AE) as graded by NCI CTCAE v.4.03 [ Time Frame: 5 years ]
    Frequency of patients experiencing treatment-emergent AEs (TEAEs)
Original Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2017)
  • MMR by 18 months [ Time Frame: 18 months ]
  • Complete Cytogenetic Response (CCyR) by 12 months [ Time Frame: 12 months ]
  • Duration of MMR and CCyR [ Time Frame: 5 years ]
  • Event Free Survival (EFS) [ Time Frame: 5 years ]
  • Overall Survival (OS) [ Time Frame: 5 years ]
  • Ctrough [ Time Frame: 3 months ]
    Population PK parameters (CL, V1, Q, V2, Ka) will be analized (PK time points: pre-dose on Day 1, Day 28, Day 56, Day 84).
  • Correlations between trough concentrations of bosutinib and key efficacy (e.g. MMR and CCyR) and safety (e.g. Nausea, Thrombocytopenia, Diarrhea, Vomiting, AST/ALT, total bilirubin, and QTc) endpoints [ Time Frame: 3 months ]
  • Adverse Event (AE) as graded by NCI CTCAE v.4.03 [ Time Frame: 5 years ]
    Frequency of patients experiencing treatment-emergent AEs (TEAEs)
Current Other Pre-specified Outcome Measures
 (submitted: April 27, 2018)
  • MMR at 3, 6, 9, 12 (in patients with both Ph+ and Ph- CP CML) and 18 months [ Time Frame: 18 months ]
  • MR1 and MR2 at 3 months and 6 months, respectively [ Time Frame: 6 months ]
  • MR4 and MR4.5 at 3, 6, 9, and 12 months [ Time Frame: 12 months ]
  • Time to MMR, MR4.0, MR4.5 and CCyR [ Time Frame: 5 years ]
  • Cumulative CHR in patients with Ph+ and both Ph+ and Ph- CP CML [ Time Frame: 5 years ]
  • Time to transformation to AP and BP CML on treatment [ Time Frame: 5 years ]
  • Type of mutations present at treatment completion/discontinuation or suboptimal response [ Time Frame: 5 years ]
  • Potential results from exploratory analyses of banked biospecimen (these results may or may not be generated in the context of the present study) [ Time Frame: 5 years ]
Original Other Pre-specified Outcome Measures
 (submitted: April 20, 2017)
  • MMR at 3, 6, 9, 12 (in patients with both Ph+ and Ph- CP CML) and 18 months [ Time Frame: 18 moths ]
  • MR1 and MR2 at 3 months and 6 months [ Time Frame: 6 months ]
  • MR4 and MR4.5 at 3, 6, 9, and 12 months [ Time Frame: 12 months ]
  • Time to MMR and CCyR [ Time Frame: 5 years ]
  • Cumulative CHR in patients with Ph+ and both Ph+ and Ph- CP CML [ Time Frame: 5 years ]
  • Time to transformation to AP and BP CML on treatment [ Time Frame: 5 years ]
  • Type of mutations present at treatment completion/discontinuation or suboptimal response [ Time Frame: 5 years ]
  • Presence of newly observed BCR-ABL mutations in patients post-baseline and correlation with response to treatment [ Time Frame: 5 years ]
  • Potential results from exploratory analyses of banked biospecimen (these results may or may not be generated in the context of the present study) [ Time Frame: 5 years ]
 
Descriptive Information
Brief Title  ICMJE Study of Bosutinib in Japanese Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
Official Title  ICMJE A PHASE 2, OPEN-LABEL, SINGLE-ARM STUDY TO EVALUATE EFFICACY AND SAFETY OF BOSUTINIB MONOTHERAPY IN JAPANESE ADULT PATIENTS WITH NEWLY DIAGNOSED CHRONIC PHASE CHRONIC MYELOGENOUS LEUKEMIA
Brief Summary Phase 2, single-arm, open-label trial. Patients will receive bosutinib for the duration of the study.
Detailed Description The study will be open for enrollment until the planned number of approximately 60 Philadelphia Chromosome Positive (Ph+) patients have been registered. All patients will be treated and/or followed for up to approximately 3 years (144 weeks) after registration of the last patient or until study termination. Patients who discontinue study therapy early due to disease progression or intolerance to study medication will continue to be followed yearly for survival for up to approximately 3 years (144 weeks) after registration of the last patient or until study termination.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Leukemia, Chronic Myelogenous
Intervention  ICMJE Drug: Bosutinib
All patinets will receive bosutinib at a starting dose of 400 mg QD.
Study Arms  ICMJE Experimental: Bosutinib
Bosutinib monotherapy; All patients will receive bosutinib at a starting dose of 400 mg QD. The dose of bosutinib may be escalated (up to a maximum of 600 mg QD) for unsatisfactory response or reduced for toxicity.
Intervention: Drug: Bosutinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 20, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2020
Actual Primary Completion Date March 12, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of CP CML of ≤6 months (from initial diagnosis); Diagnosis of CP CML with molecular confirmation by detection of BCR-ABL rearrangement at screening (cytogenetic assessment for Ph is not required for enrollment; however, patients with known Ph- CML prior to registration are not eligible for this study)
  • Age ≥20 years
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
  • Adequate Liver and Renal Function

Exclusion Criteria:

  • Any prior medical treatment for CML, including TKIs, with the exception of hydroxyurea treatment, which is permitted for up to 6 months prior to registration
  • Any past or current CNS involvement, including leptomeningeal leukemia
  • Extramedullary disease only
  • Major surgery or radiotherapy within 14 days prior to registration
  • History of clinically significant or uncontrolled cardiac disease
  • Patients with active, uncontrolled bacterial, fungal, or viral infection
  • Recent or ongoing clinically significant GI disorder
  • History of another malignancy within 5 years prior to registration
  • Uncontrolled hypomagnesemia or uncorrected hypokalemia due to potential effects on the QT interval
  • Known prior or suspected severe hypersensitivity to study drugs or any component in their formulations
  • Participation in other studies involving investigational drug(s) within 30 days or 5 half-lives of investigational product, whichever is longer, prior to registration and/or during study participation
  • Other severe acute or chronic medical or psychiatric condition, including recent or active suicidal ideation or behavior, or laboratory abnormality that may increase the risk associated with study participation or interfere with the interpretation of study results
  • Investigational site staff members directly involved in the conduct of the study and their family members, or Pfizer employees, including their family members, directly involved in the conduct of the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03128411
Other Study ID Numbers  ICMJE B1871048
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP