Clinical trial NCT00337454: Study of BMS-354825 in Subjects With CML Who Are Resistant to or Intolerant of Imatinib or Ph+All in Japan
Official title: A Phase I/II Study of BMS-354825 in Subjects With Imatinib Resistant or Intolerant Philadelphia Chromosome Positive Chronic Myelogenous Leukemia and Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Myelogenous Leukemia
Keywords: Imatinib resistant or intolerant CML
Treatment resistant or intolerant Ph+ALL
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-06-16
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is composed of Phase I and Phase II part. Phase I part: The objective is to evaluate the safety of BMS-354825 in subject with chronic phase Chronic Myelogenous Leukemia (CML). Dosage of BMS-354825 will be 50 mg BID, 70 mg BID or 90 mg BID. Phase II part: The objective is to evaluate the efficacy of BMS-354825. dosage will be decided according to the results of Phase I part. Treatment period will be 6 months for subjects with chronic phase CML, and 3 months for subjects with accelerated phase or blast phase CML and Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL)


Eligibility criteria: Inclusion Criteria:

* Philadelphia chromosome positive or bcr-abl gene positive
* Chronic Myelogenous Leukemia (CML)
* Subjects must have primary or acquired resistance to imatinib mesylate or have intolerance of imatinib mesylate
* Philadelphia Chromosome Positive Acute Lymphoblastic leukemia (Ph+ALL)
* Subjects must have primary or acquired resistance to chemotherapy or have intolerance of chemotherapy
* Performance status (general conditions) specified by the Eastern Cooperative Oncology Group: 0-2
* Men and women, ages 20 - 75
* Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 3 months after the study in such a manner that the risk of pregnancy is minimized

Exclusion Criteria:

* Subjects who are eligible and willing to undergo transplantation at pre-study
* Women who are pregnant or breastfeeding
* Uncontrolled or significant cardiovascular disease
* History of significant bleeding disorder unrelated to CML or ALL
* Adequate hepatic function
* Adequate renal function
* Medication that increase bleeding risk
* Medication that change heart rhythms
* Subjects who are compulsorily detained for legal reasons or treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study

Primary outcomes:
measure: Evaluate the safety of BMS-354825 administered orally twice daily for 4 weeks, evaluate the efficacy of BMS-354825 as defined by cytogenetic response for subjects with chronic phase CML, and as defined by hematologic response
Secondary outcomes:
measure: Pharmacokinetic profiles, cytogenetic response and hematologic response, BCR-ABL point mutations and biochemical assays of BCR-ABL, safety, time to and duration of hematologic and cytogenetic response
measure: response
Other outcomes:
Locations:
city: Nagoya-Shi
country: Japan
facility: Local Institution
state: Aichi
city: Nagoya
country: Japan
facility: Local Institution
state: Aichi
city: Nagoya
country: Japan
facility: Local Institution
state: Aichi
city: Maebashi
country: Japan
facility: Local Institution
state: Gunma
city: Nishinomiya-Shi
country: Japan
facility: Local Institution
state: Hyogo
city: Kagoshima-Shi
country: Japan
facility: Local Institution
state: Kagoshima
city: Isehara-Shi
country: Japan
facility: Local Institution
state: Kanagawa
city: Sendai
country: Japan
facility: Local Institution
state: Miyagi
city: Nagasaki City
country: Japan
facility: Local Institution
state: Nagasaki
city: Okayama-Shi
country: Japan
facility: Local Institution
state: Okayama
city: Moriguchi
country: Japan
facility: Local Institution
state: Osaka
city: Iruma-Gun
country: Japan
facility: Local Institution
state: Saitama
city: Hamamatsu-Shi
country: Japan
facility: Local Institution
state: Shizuoka
city: Bunkyo-Ku
country: Japan
facility: Local Institution
state: Tokyo
city: Chuo-Ku
country: Japan
facility: Local Institution
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: Local Institution
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: Local Institution
state: Tokyo
city: Kanagawa
country: Japan
facility: Local Institution
city: Kyoto
country: Japan
facility: Local Institution
city: Tochigi
country: Japan
facility: Local Institution
city: Tokyo
country: Japan
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: