NCT03128411

Brief Summary

Phase 2, single-arm, open-label trial. Patients will receive bosutinib for the duration of the study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2017

Typical duration for phase_2

Geographic Reach
1 country

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2017

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 25, 2017

Completed
20 days until next milestone

Study Start

First participant enrolled

May 15, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2019

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

November 24, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2021

Completed
Last Updated

May 19, 2022

Status Verified

April 1, 2022

Enrollment Period

1.8 years

First QC Date

March 28, 2017

Results QC Date

March 12, 2020

Last Update Submit

April 26, 2022

Conditions

Leukemia, Chronic Myelogenous

Keywords

Leukemia, Chronic Myelogenous

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Major Molecular Response (MMR) at Month 12

    A MMR is defined as less than or equal to (\<=) 0.1 percent (%) BCR-ABL transcripts on the international scale (IS), corresponding to a \>=3-log reduction from standardized baseline with at least 3000 ABL assessed by the central laboratory. The MMR value counted only if the response was demonstrated at the 12-month visit; any MMR gained and lost, or never achieved at or before the 12-month visit was considered as non-responder.

    Month 12

Secondary Outcomes (36)

  • Percentage of Participants With Major Molecular Response (MMR) by Month 12

    Up to Month 12

  • Percentage of Participants With Major Molecular Response (MMR) by Month 18

    Up to Month 18

  • Percentage of Participants With Complete Cytogenetic Response (CCyR) by Month 12

    Up to Month 12

  • Probability of Maintaining Major Molecular Response (MMR) at Month 36

    At Month 36

  • Probability of Maintaining Complete Cytogenetic Response (CCyR) at Month 36

    At Month 36

  • +31 more secondary outcomes

Study Arms (1)

Bosutinib

EXPERIMENTAL

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.

Drug: Bosutinib

Interventions

BosutinibDRUG

All patients will receive bosutinib at a starting dose of 400 mg QD.

Bosutinib

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Fujita Health University Hospital

Toyoake, Aichi-ken, 470-1192, Japan

Location

Toyohashi Municipal Hospital

Toyohashi, Aichi-ken, 441-8570, Japan

Location

Akita University Hospital

Akita, Akita, 010-8543, Japan

Location

Japanese Red Cross Narita Hospital

Narita, Chiba, 286-8523, Japan

Location

Ehime University Hospital

Toon-shi, Ehime, 791-0295, Japan

Location

Kobe City Medical Center General Hospital

Kobe, Hyōgo, 650-0047, Japan

Location

Ishikawa Prefectural Central Hospital

Kanazawa, Ishikawa-ken, 920-8530, Japan

Location

Yokohama City University Medical Center

Yokohama, Kanagawa, 232-0024, Japan

Location

National Hospital Organization Osaka Minami Medical Center

Kawachi-Nagano, Osaka, 586-8521, Japan

Location

Osaka City University Hospital

Osaka, Osaka, 545-8586, Japan

Location

Kindai University Hospital

Ōsaka-sayama, Osaka, 589-8511, Japan

Location

Hamamatsu University Hospital

Hamamatsu, Shizuoka, 431-3192, Japan

Location

Juntendo University Hospital

Bunkyo-ku, Tokyo, 113-8431, Japan

Location

Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

Bunkyo-ku, Tokyo, 113-8677, Japan

Location

NTT Medical Center Tokyo

Shinagawa-ku, Tokyo, 141-8625, Japan

Location

National Hospital Organization Disaster Medical Center

Tachikawa, Tokyo, 190-0014, Japan

Location

Yamagata University Hospital

Yamagata, Yamagata, 990-9585, Japan

Location

Chiba University Hospital

Chiba, 260-8677, Japan

Location

National Hospital Organization Kyushu Cancer Center

Fukuoka, 811-1395, Japan

Location

Saga University Hospital

Saga, 849-8501, Japan

Location

Nippon Medical School Hospital

Tokyo, 113-8603, Japan

Location

Related Publications (4)

  • Garrett M, Knight B, Cortes JE, Deininger MW. Population modeling of bosutinib exposure-response in patients with newly diagnosed chronic phase chronic myeloid leukemia. Cancer Med. 2023 Sep;12(17):17981-17992. doi: 10.1002/cam4.6439. Epub 2023 Aug 8.

    PMID: 37553873DERIVED

  • Ono T, Hino M, Matsumura I, Fujisawa S, Ishizawa K, Sakaida E, Sekiguchi N, Ono C, Aizawa M, Tanetsugu Y, Koide Y, Takahashi N. Bosutinib in Japanese patients with newly diagnosed chronic-phase chronic myeloid leukemia: final 3-year follow-up results of a phase 2 study. Int J Hematol. 2022 Dec;116(6):871-882. doi: 10.1007/s12185-022-03435-4. Epub 2022 Aug 13.

    PMID: 35963986DERIVED

  • Takahashi N, Cortes JE, Sakaida E, Ishizawa K, Ono T, Doki N, Matsumura I, Garcia-Gutierrez V, Rosti G, Ono C, Ohkura M, Tanetsugu Y, Viqueira A, Brummendorf TH. Safety profile of bosutinib in Japanese versus non-Japanese patients with chronic myeloid leukemia: a pooled analysis. Int J Hematol. 2022 Jun;115(6):838-851. doi: 10.1007/s12185-022-03314-y. Epub 2022 Mar 2.

    PMID: 35235189DERIVED

  • Hino M, Matsumura I, Fujisawa S, Ishizawa K, Ono T, Sakaida E, Sekiguchi N, Tanetsugu Y, Fukuhara K, Ohkura M, Koide Y, Takahashi N. Phase 2 study of bosutinib in Japanese patients with newly diagnosed chronic phase chronic myeloid leukemia. Int J Hematol. 2020 Jul;112(1):24-32. doi: 10.1007/s12185-020-02878-x. Epub 2020 Apr 11.

    PMID: 32279228DERIVED

Related Links

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

bosutinib

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2017

First Posted

April 25, 2017

Study Start

May 15, 2017

Primary Completion

March 12, 2019

Study Completion

March 4, 2021

Last Updated

May 19, 2022

Results First Posted

November 24, 2020

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

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.

More information

Locations

JP(21)