You are here

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

Last updated on March 14, 2019

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 city or zip code to find studies near you.

Based on your search, you may also be interested in

Chronic Myelogenous Leukemia
NCT02501330
All Genders
0+
Years
Shibuya-ku,

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now