You are here

Study Evaluating SKI-606 (Bosutinib) In Japanese Subjects With Philadelphia Chromosome Positive Leukemias

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Tohoku University Hospital
Sendai-city, Miyagi, 980-8574 Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Myelogenous Leukemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-74 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Cytogenetic or Polymerase Chain Reaction based diagnosis of Chronic phase of
Philadelphia Chromosome Positive Chronic Myelogenous Leukemia:

(Part 1), any phase of Philadelphia Chromosome Positive Chronic Myelogenous Leukemia (Part
2), whose disease is resistant/refractory to full-dose imatinib (400 mg for chronic phase
subjects/600 mg for advanced leukemia subjects), or are intolerant of any dose of imatinib.

- Adequate duration of prior imatinib therapy.

- No prior exposure to Src, Abl, or Src/Abl kinase inhibitors other than imatinib.

- Eastern Cooperative Oncology Group Performance Status of 0 or 1 for chronic phase
subjects, and 0, 1 or 2 for Advanced Stage subjects.

- At least 7 days since any anti-proliferative treatment (including intrathecal
chemotherapy) before the first dose of SKI-606, (except hydroxyurea).

- Recovered to National Cancer Institute grade 0-1, or to baseline, from any toxicities
of prior anti-tumor treatment, other than alopecia or thrombocytopenia due to active
prior treatment (intolerant subjects).

- At least 3 months post allogeneic stem cell transplantation before the first dose of
SKI-606.

- Able to take daily oral capsules reliably.

- Absolute neutrophil count greater than 1,000/mL (Part 1)

- Adequate hepatic, and renal function.

- Documented normal INR if not on oral anticoagulant therapy, or, if on oral
anticoagulant therapy consistent target INR less than 3.

- Age should be greater than 20 years and less than 75 years (Part 1), greater than 20
years (Part 2), including women of childbearing potential.

- Willingness of male and female subjects, who are not surgically sterile or
postmenopausal, must agree and commit to the use of reliable methods of birth control
(oral contraceptives, intrauterine devices, or barrier methods used with a spermicide)
for the duration of the study and for 30 days after the last dose of SKI-606.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Subjects with Philadelphia chromosome negative Chronic Myelogenous Leukemia.

- Overt leptomeningeal leukemia. Subjects must be free of CNS involvement according to
the symptoms for a minimum of 2 months before the first dose of SKI-606. Subjects with
CNS symptoms must have a diagnostic lumbar puncture prior to study enrollment.

- Subjects with extramedullary disease only.

- Ongoing requirement for warfarin or other oral anticoagulant therapy (Part 1).

- Ongoing requirement for hydroxyurea (Part 1).

- Graft Versus Host Disease. a. no previous Graft Versus Host Disease allowed (Part 1).
b. no treated or untreated Graft Versus Host Disease within 60 days of first dose
(Part 2).

- Major surgery within 14 days or radiotherapy within 7 days before the first dose of
SKI-606 (recovery from any previous surgery should be complete before day 1).

- Ongoing clinical requirement for administration of a strong inhibitor or inducer of
CYP-3A4 (Part 1).

- History of clinically significant or uncontrolled cardiac disease including: a.
history of a clinically significant ventricular arrhythmia (such as ventricular
tachycardia, ventricular fibrillation, or Torsades de pointes) b. diagnosed or
suspected congenital or acquired prolonged QT syndrome c. history of prolonged QTc d.
unexplained syncope e. history of or active congestive heart failure f. myocardial
infarction within 12 months. g. Uncontrolled angina or hypertension within 3 months.

- Baseline QTcF greater than 0.45 sec (average of triplicate readings).

- Concomitant use of or need for medications known to prolong the QT interval.

- Uncorrected hypomagnesemia or hypokalemia due to potential effects on the QT interval.

- Recent (within 14 days before the first dose of SKI-606) or ongoing clinically
significant gastrointestinal disorder.

- Pregnant or breastfeeding women.

- Evidence of serious active infection, or significant medical or psychiatric illness.

NCT00811070
Pfizer
Completed
Study Evaluating SKI-606 (Bosutinib) In Japanese Subjects With Philadelphia Chromosome Positive Leukemias

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Study Evaluating SKI-606 (Bosutinib) In Japanese Subjects With Philadelphia Chromosome Positive Leukemias
A Phase 1/2 Study Of SKI-606 Administered As A Single Agent In Japanese Subjects With Philadelphia Chromosome Positive Leukemias
This is a two-part safety and efficacy study of SKI-606 in subjects who have Philadelphia chromosome positive leukemias (CML). Part 1 will be a dose-escalation study, in which an escalating dose of SKI-606 (Bosutinib), up to 600 mg, will be studied in subjects with imatinib resistant/refractory or imatinib intolerant chronic phase CML. Part 2 will evaluate the safety and efficacy of the maximum tolerated dose (MTD) of SKI-606 (Bosutinib)identified in Part 1 of the study.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Chronic Myelogenous Leukemia
Drug: SKI-606 (Bosutinib)

Formulation: 100 mg Capsule for Part 1, 100 mg tablet for Part1 and Part 2.

SKI-606 (Bosutinib) will be taken by mouth with water and food as continuous once-daily dosing.

Experimental: 1
Intervention: Drug: SKI-606 (Bosutinib)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
June 2015
March 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Cytogenetic or Polymerase Chain Reaction based diagnosis of Chronic phase of Philadelphia Chromosome Positive Chronic Myelogenous Leukemia:

(Part 1), any phase of Philadelphia Chromosome Positive Chronic Myelogenous Leukemia (Part 2), whose disease is resistant/refractory to full-dose imatinib (400 mg for chronic phase subjects/600 mg for advanced leukemia subjects), or are intolerant of any dose of imatinib.

  • Adequate duration of prior imatinib therapy.
  • No prior exposure to Src, Abl, or Src/Abl kinase inhibitors other than imatinib.
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1 for chronic phase subjects, and 0, 1 or 2 for Advanced Stage subjects.
  • At least 7 days since any anti-proliferative treatment (including intrathecal chemotherapy) before the first dose of SKI-606, (except hydroxyurea).
  • Recovered to National Cancer Institute grade 0-1, or to baseline, from any toxicities of prior anti-tumor treatment, other than alopecia or thrombocytopenia due to active prior treatment (intolerant subjects).
  • At least 3 months post allogeneic stem cell transplantation before the first dose of SKI-606.
  • Able to take daily oral capsules reliably.
  • Absolute neutrophil count greater than 1,000/mL (Part 1)
  • Adequate hepatic, and renal function.
  • Documented normal INR if not on oral anticoagulant therapy, or, if on oral anticoagulant therapy consistent target INR less than 3.
  • Age should be greater than 20 years and less than 75 years (Part 1), greater than 20 years (Part 2), including women of childbearing potential.
  • Willingness of male and female subjects, who are not surgically sterile or postmenopausal, must agree and commit to the use of reliable methods of birth control (oral contraceptives, intrauterine devices, or barrier methods used with a spermicide) for the duration of the study and for 30 days after the last dose of SKI-606.

Exclusion Criteria:

  • Subjects with Philadelphia chromosome negative Chronic Myelogenous Leukemia.
  • Overt leptomeningeal leukemia. Subjects must be free of CNS involvement according to the symptoms for a minimum of 2 months before the first dose of SKI-606. Subjects with CNS symptoms must have a diagnostic lumbar puncture prior to study enrollment.
  • Subjects with extramedullary disease only.
  • Ongoing requirement for warfarin or other oral anticoagulant therapy (Part 1).
  • Ongoing requirement for hydroxyurea (Part 1).
  • Graft Versus Host Disease. a. no previous Graft Versus Host Disease allowed (Part 1). b. no treated or untreated Graft Versus Host Disease within 60 days of first dose (Part 2).
  • Major surgery within 14 days or radiotherapy within 7 days before the first dose of SKI-606 (recovery from any previous surgery should be complete before day 1).
  • Ongoing clinical requirement for administration of a strong inhibitor or inducer of CYP-3A4 (Part 1).
  • History of clinically significant or uncontrolled cardiac disease including: a. history of a clinically significant ventricular arrhythmia (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes) b. diagnosed or suspected congenital or acquired prolonged QT syndrome c. history of prolonged QTc d. unexplained syncope e. history of or active congestive heart failure f. myocardial infarction within 12 months. g. Uncontrolled angina or hypertension within 3 months.
  • Baseline QTcF greater than 0.45 sec (average of triplicate readings).
  • Concomitant use of or need for medications known to prolong the QT interval.
  • Uncorrected hypomagnesemia or hypokalemia due to potential effects on the QT interval.
  • Recent (within 14 days before the first dose of SKI-606) or ongoing clinically significant gastrointestinal disorder.
  • Pregnant or breastfeeding women.
  • Evidence of serious active infection, or significant medical or psychiatric illness.
Sexes Eligible for Study: All
20 Years to 74 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00811070
3160A4-2203
B1871007 ( Other Identifier: Alias Study Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now