Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00261846
First received: December 2, 2005
Last updated: October 15, 2014
Last verified: October 2014
  Purpose

This is an open-label, continuous daily dosing, two-part safety and efficacy study of SKI-606 (bosutinib) in Philadelphia chromosome positive leukemias (Ph+). Part 1 is a dose-escalation study in chronic phase Chronic Myelogenous Leukemia (CML) subjects to establish the maximum tolerated dose (MTD) in this subject population. Part 2 has begun after the completion of Part 1 and after a dose has been established for the compound in chronic phase subjects. Part 2 is a study of the the efficacy of 500mg daily oral SKI-606 (bosutinib) in patients with all phases of Ph+ CML and Ph+ Acute Lymphocytic Leukemia (ALL). The protocol will test the hypotheses that oral daily dosing of bosutinib at 500 mg will attain (1) Major Cytogenetic Response (MCyR) in chronic phase CML patients and (2) Overall Hematological Response (OHR) in advanced leukemia patients. Each phase of the disease will be evaluated as a separate cohort.


Condition Intervention Phase
Chronic Myeloid Leukemia
Drug: Bosutinib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study Of Ski-606 In Philadelphia Chromosome Positive Leukemias

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Dose Limiting Toxicity (DLT) [ Time Frame: Part 1 Baseline up to Day 28 ] [ Designated as safety issue: Yes ]
    DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity, any clinically-significant grade 2 non-hematologic toxicity that requires 14 days to resolve (to grade 1).

  • Maximum Tolerated Dose (MTD) [ Time Frame: Part 1 Baseline up to Day 28 ] [ Designated as safety issue: Yes ]
    MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced DLT. DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity, any clinically-significant grade 2 non-hematologic toxicity that requires 14 days to resolve (to grade 1).

  • Maximum Observed Plasma Concentration (Cmax) - Part 1 [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1 ] [ Designated as safety issue: No ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) - Part 1 [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1 ] [ Designated as safety issue: No ]
  • Plasma Decay Half-Life (t1/2) - Part 1 [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1 ] [ Designated as safety issue: No ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) - Part 1 [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1 ] [ Designated as safety issue: No ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).

  • Area Under the Concentration-Time Curve (AUC) - Part 1 [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1 ] [ Designated as safety issue: No ]
    AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. There were fewer participants evaluable for AUC values than participants evaluable for AUClast because terminal half-life of some participants was not accurately estimated and therefore AUC in these participants was not calculated.

  • Apparent Oral Clearance (CL/F) - Part 1 [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1 ] [ Designated as safety issue: No ]
    Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

  • Apparent Volume of Distribution (Vz/F) - Part 1 [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1 ] [ Designated as safety issue: No ]
    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.

  • Maximum Observed Plasma Concentration at Steady State (Cmax,ss) - Part 1 [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15 ] [ Designated as safety issue: No ]
    Maximum plasma concentration over 24 hours at steady state (ss), on Day 15.

  • Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax,ss) - Part 1 [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15 ] [ Designated as safety issue: No ]
    Time to reach maximum observed plasma concentration over 24 hours at steady state (ss), on Day 15.

  • Plasma Decay Half-Life at Steady State (t1/2,ss) - Part 1 [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15 ] [ Designated as safety issue: No ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Plasma decay half-life over 24 hours at steady state (ss), on Day 15 was calculated.

  • Area Under the Concentration-Time Curve at Steady State (AUCss) - Part 1 [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15 ] [ Designated as safety issue: No ]
    AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. AUC over 24 hours at steady state (ss), on Day 15 was calculated.

  • Apparent Oral Clearance at Steady State (CL/F,ss) - Part 1 [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15 ] [ Designated as safety issue: No ]
    Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Apparent oral clearance over 24 hours at steady state (ss), on Day 15 was calculated.

  • Accumulation Ratio (R) [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 1 and Day 15 ] [ Designated as safety issue: No ]
    R=accumulation ratio (AUCss on Day 15/AUC[0-24] on Day 1)

  • Percentage of Participants With Major Cytogenetic Response (MCyR) at Week 24 in Chronic Phase Second-line Imatinib Resistant CML Population - Part 2 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells. Major cytogenetic response was categorized as either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CCyR was achieved when there was 0 percent (%) Ph+ cells and PCyR was achieved when 1 to 35% Ph+ cells.

  • Population Pharmacokinetics - Part 2 [ Time Frame: 0 (pre-dose), 2, 4, 6 hours on Day 1, Day 21, 20-23 hours post-dose on Day 21, 0 (pre-dose) hours on Day 84, 168, 252 ] [ Designated as safety issue: No ]
    Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.


Secondary Outcome Measures:
  • Percentage of Participants With Major Cytogenetic Response (MCyR) - Part 1 [ Time Frame: Baseline, thereafter assessed every 12 weeks up to 2 years then every 24 weeks up to Year 5 ] [ Designated as safety issue: No ]
    Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells. Major cytogenetic response was categorized as either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CCyR was achieved when there was 0 percent (%) Ph+ cells and PCyR was achieved when 1 to 35% Ph+ cells.

  • Phosphorylation Inhibition of Breakpoint Cluster Region-Abelson Kinase (Bcr-Abl) - Part 1 [ Time Frame: Baseline, Week 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks up to Year 5 ] [ Designated as safety issue: No ]
    bcr-Abl is a protein resulting from the transcription of the Philadelphia chromosome following 9:22 chromosomal translocation, and phosphorylation inhibition of which correlates with inhibition of tumor cell growth.

  • Phosphorylated Cancer-Testis 10 (CT10) Regulator of Kinase Like (p-CrkL) Protein Level in Blood at Baseline - Part 1 [ Time Frame: 0 (pre-dose) on Day 1 (Baseline) ] [ Designated as safety issue: No ]
    CrkL is a protein, phosphorylation of which has been shown to correlate with CML cell growth; and conversely inhibition of their phosphorylation correlates with inhibition of tumor cell growth. Phosphorylation of CrkL was monitored in whole blood cells by using fluorescent activated cell sorter (FACS) flow cytometry. Amount of CrkL protein phosphorylated (in moles) per 100 blood cells was reported.

  • Percent Change From Baseline in Phosphorylated Cancer-testis 10 (CT10) Regulator of Kinase Like (p-CrkL) Protein Level in Blood at Day 1, 8 and 15 - Part 1 [ Time Frame: 6 hours post-dose on Day 1, 0 (pre-dose), 6 hours post-dose on Day 8, 15 ] [ Designated as safety issue: No ]
    CrkL is a protein, phosphorylation of which has been shown to correlate with CML cell growth; and conversely inhibition of their phosphorylation correlates with inhibition of tumor cell growth. Phosphorylation of CrkL was monitored in whole blood cells by using FACS flow cytometry. Percent change in p-CrkL protein at different time points give measure of phosphorylation inhibition from baseline.

  • Percentage of Participants With Major Cytogenetic Response (MCyR) in Chronic Phase Second-line Imatinib Intolerant CML and Chronic Phase Third-line CML Population - Part 2 [ Time Frame: Week 24 for second line, Baseline through Week 24 for third line ] [ Designated as safety issue: No ]
    Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells in metaphase from Bone Marrow (BM) sample. Major cytogenetic response was categorized as either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CCyR was achieved when there was 0 percent (%) Ph+ cells in metaphase in BM and PCyR was achieved when 1 to 35% Ph+ cells in metaphase in BM.

  • Percentage of Participants With Major Cytogenetic Response (MCyR) in Chronic Phase Second-line CML and Chronic Phase Third-line CML - Part 2 [ Time Frame: Baseline, Week 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks up to Year 5 ] [ Designated as safety issue: No ]
    Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells in metaphase from Bone Marrow (BM) sample. Major cytogenetic response was categorized as either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CCyR was achieved when there was 0% Ph+ cells in metaphase in BM and PCyR was achieved when 1 to 35% Ph+ cells in metaphase in BM.

  • Duration of Major Cytogenetic Response (MCyR) in Chronic Phase Second-line CML and Chronic Phase Third-line CML - Part 2 [ Time Frame: Baseline, Week 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks up to Year 5 ] [ Designated as safety issue: No ]

    Duration of MCyR was defined as the interval from the date of the earliest demonstration of a response, until the earliest date of loss of that response.

    Duration of response in weeks = (date of confirmed loss of first attained response minus date of first attained response)/7 days. Major cytogenetic response was categorized as either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CCyR was achieved when there was 0 percent (%) Ph+ cells in metaphase in BM and PCyR was achieved when 1 to 35% Ph+ cells in metaphase in BM.


  • Time to Achieve Major Cytogenetic Response (MCyR) in Chronic Phase Second-line CML and Chronic Phase Third-line CML - Part 2 [ Time Frame: Baseline, Week 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks up to Year 5 ] [ Designated as safety issue: No ]

    Time to MCyR was the interval from the date of first dose of study medication until the first date of achieving a given response.

    Time to response in weeks = (event date - first dose date plus 1)/7, where the event date is the non-missing date of the first attained response or last cytogenetic assessment date of a participants. Major cytogenetic response was categorized as either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CCyR was achieved when there was 0 percent (%) Ph+ cells in metaphase in BM and PCyR was achieved when 1 to 35% Ph+ cells in metaphase in BM.


  • Duration of Complete Hematologic Response (CHR) - Part 2 [ Time Frame: Baseline, Day 1 and 7 of Week 1, Day 7 of Week 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks up to Year 5 ] [ Designated as safety issue: No ]
    The duration of CHR was defined as the interval from the first date of response until the first date of confirmed loss of response. Duration of response in weeks =(date of confirmed loss of first attained response - date of first attained response)/7. CHR response was considered to be achieved if participants met all of the following criteria: White Blood Cells =< institutional upper limit of normal, no peripheral blood blasts or promyelocytes, myelocytes+metamyelocytes <5% in blood, absolute neutrophil count >=1.0*10^9 per liter (/L), platelets >=100 but <450*10^9/L unless related to therapy, <20% basophils in blood and no extramedulary involvement (including hepato- or splenomegaly), =<5% BM blasts.

  • Time to Achieve Complete Hematologic Response (CHR) - Part 2 [ Time Frame: Baseline, Day 1 and 7 of Week 1, Day 7 of Week 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks up to Year 5 ] [ Designated as safety issue: No ]
    The time to CHR was measured from the date of first dosing to the first date of response. Time to response in weeks = (event date - first dose date plus 1)/7, where the event date is the non-missing date of the first attained response or last assessment date of a participant. Hematologic response was considered to be achieved if participants met all of the following criteria of CHR: White Blood Cells =< institutional upper limit of normal, no peripheral blood blasts or promyelocytes, myelocytes+metamyelocytes <5% in blood, absolute neutrophil count >= 1.0*10^9 per liter (/L), platelets >=100*10^9/L but <450*10^9/L, <20% basophils in blood and no extramedulary involvement (including hepato- or splenomegaly), =<5% BM blasts.

  • Progression Free Survival (PFS) Rate - Part 2 [ Time Frame: Baseline up to Year 1, Year 2 ] [ Designated as safety issue: No ]
    PFS was based on Kaplan-Meier estimates. PFS was defined as time in weeks from start of study treatment to treatment discontinuation due to disease progression as assessed by the investigator. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from death case report forms (CRFs).

  • Overall Survival (OS) Rate - Part 2 [ Time Frame: Baseline up to Year 2 ] [ Designated as safety issue: No ]
    OS was based on Kaplan-Meier method. Survival was defined as the time period from the date of first dose of bosutinib to the date of death, censored at the participant's last contact date.

  • Percentage of Participants With Complete Hematologic Response (CHR) in Advanced Leukemia Population - Part 2 [ Time Frame: Baseline, Day 1 and 7 of Week 1, Day 7 of Week 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks up to Year 5 ] [ Designated as safety issue: No ]
    Hematologic response was considered to be achieved if participants met all of the following criteria of CHR: White Blood Cells =< institutional upper limit of normal, no peripheral blood blasts or promyelocytes, myelocytes+metamyelocytes <5% in blood, absolute neutrophil count >= 1.0*10^9 per liter (/L), platelets >=100*10^9/L but <450*10^9/L, <20% basophils in blood and no extramedulary involvement (including hepato- or splenomegaly), =<5% BM blasts.

  • Percentage of Participants With Overall Hematologic Response (OHR) by Week 48 in Advanced Leukemia Population - Part 2 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    OHR included CHR, no evidence of leukemia (NEL), minor hematologic response (MiHR) or return to chronic phase (RCP), participants had to meet at least 1 of this criterion. Criteria for RCP: disappearance of features defining AP/BP, but still in CP and persistence of clonal evolution. Criteria for MiHR: <15% blasts in blood and BM, <30% blasts+promyelocytes in blood and BM, <20% basophils in blood, no extramedullary disease other than liver/spleen. Criteria for CHR and NEL: <20% basophils in blood, no extramedullary involvement including liver/spleen, no peripheral blasts or promyelocytes, myelocytes + metamyelocytes <5% in blood, <5% (NEL) and <=5% (CHR) marrow blasts, 0.5*10^9 <= Absolute neutrophil count (ANC) <1.0*10^9/L (NEL) and ANC>=1.0*10^9/L (CHR), 20*10^9 <=platelets<100 *10^9/L (NEL) and platelets>=100 but <450x10^9/L (CHR), white blood cells <=institutional upper limit of the normal range.

  • Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Baseline up to follow up visit (30 days after last dose of study treatment) ] [ Designated as safety issue: No ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

  • Duration of Potentially Clinically Important (PCI) Adverse Events (AEs) [ Time Frame: Baseline up to follow up visit (30 days after last dose of study treatment) ] [ Designated as safety issue: Yes ]
    An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. PCI-AEs included hepatotoxicity, gastrointestinal toxicity: diarrhea, nausea, vomiting, hypersensitivity reactions, rash, edema, effusion, myelosuppression, hemorrhage, infection, cardiac events. Duration of AE was calculated as (stop date minus start date) plus 1 for non-missing and non-partial dates.

  • Number of Participants With Change From Baseline in Laboratory Tests Results [ Time Frame: Week 1, 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks up to Year 5 ] [ Designated as safety issue: Yes ]
    Laboratory values included urinalysis, complete blood count (CBC), prothrombin time/partial thromboplastin time (PT/PTT), international normalized ratio (INR), blood chemistry and serum pregnancy test (β-HCG). Potentially clinically important (PCI) changes in laboratory assessments were reported. Any laboratory value that was identified as clinically significant was reported as an AE. PCI laboratory values were defined as National Cancer Institute Common Toxicity Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0) grade 3 or higher.

  • Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings [ Time Frame: Baseline, 0 (pre-dose), 2, 4, 6 hours on Day 1, 0 (pre-dose), 2, 4, 6, 20-23 hours on Day 21, and end of treatment visit ] [ Designated as safety issue: Yes ]
    Criteria for PCI changes in ECG (12-lead) were defined as: no sinus rhythm; PR interval >=220 msec and increase of >=20 msec; QRS interval >=120 msec; QT interval corrected using the Fridericia formula (QTcF) and QT interval corrected using the Bazett's formula (QTcB) >500 msec or increase of >60 msec; heart rate <=45 beats per minute (bpm) or >=120 bpm or decrease/increase of >=15 bpm.

  • Number of Participants With Change From Baseline in Findings of Chest X-ray [ Time Frame: Baseline, Week 8, and end of treatment ] [ Designated as safety issue: Yes ]
  • Number of Participants Who Received Concomitant Medications for Management of Adverse Events (AEs) [ Time Frame: Baseline up to end of treatment (Year 5) ] [ Designated as safety issue: Yes ]
    Number of participants taking any non-study medications which were administered from Study Day 1 to 30 days after last dose of study treatment as a management of an AE are reported.

  • Number of Participants With Change From Baseline in Eastern Co-operative Oncology Group Performance Status (ECOG-PS) [ Time Frame: Baseline, Week 1, 2, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks up to Year 5 ] [ Designated as safety issue: Yes ]
    ECOG-PS measured on-therapy (time between first dose and last dose date with a 30-day lag) assessed participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (>50% of waking hrs), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead.

  • Number of Participants With Change From Baseline in Physical Examinations and Vital Signs [ Time Frame: Baseline up to end of treatment (Year 5) ] [ Designated as safety issue: Yes ]
    Number of participants with PCI physical examinations and vital signs is reported during therapy and at post therapy. Criteria for PCI change in vital signs: heart rate value of <40 beats per minute and value >150 beats per minute, systolic blood pressure (SBP) of <80 or >210 millimeter of mercury (mmHg), diastolic blood pressure (DBP) of <40 or >130 mmHg, temperature <32 or >40 degree centigrade, respiratory rate of <10 or >50 breaths/minute and criteria for PCI change in physical examination: >=10% increase or decrease of body weight (Wt) in kilogram (kg).


Enrollment: 571
Study Start Date: January 2006
Estimated Study Completion Date: January 2015
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SKI-606 Drug: Bosutinib

Part 1, starting dose 400 mg oral, daily dosing in the dose-escalation component.

Part 2, 500 mg oral, continuous, daily dosing.

Other Name: SKI-606

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ph+ CML or Ph+ ALL who are primarily refractory to full-dose imatinib (600 mg), have disease progression/relapse while on full-dose imatinib, or are intolerant of any dose of imatinib.
  • At least 3 months post stem cell transplantation
  • Able to take daily oral capsules/tablets reliably

Exclusion Criteria:

  • Subjects with Philadelphia chromosome, and bcr-abl negative CML
  • Overt leptomeningeal leukemia
  • Subjects without evidence of leukemia in bone marrow (extramedullary disease only)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00261846

  Hide Study Locations
Locations
United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010-3000
United States, Colorado
HealthONE Presbyterian/St. Luke's Medical Center
Denver, Colorado, United States, 80218
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218
United States, District of Columbia
Lombardi Comprehensive Cancer Center
Washington, District of Columbia, United States, 20007
Oladapo Kolawole & Maureen Rose
Washington, District of Columbia, United States, 20007-2197
United States, Georgia
Emory Clinic
Atlanta, Georgia, United States, 30322
Emory University Hospital
Atlanta, Georgia, United States, 30322
Investigational Drug Service (Drug Ship)
Atlanta, Georgia, United States, 30322
Winship Cancer Institute
Atlanta, Georgia, United States, 30322
United States, Illinois
Oncology Specialists, SC
Niles, Illinois, United States, 60714
Oncology Specialists S.C.
Park Ridge, Illinois, United States, 60068
United States, Indiana
Indiana Blood and Marrow Transplantation, LLC
Beech Grove, Indiana, United States, 46107
Indiana Blood and Marrow Transplantation Research
Indianapolis, Indiana, United States, 46237
United States, Louisiana
Critical Care Research Center at Louisiana State University Health Sciences Center
Shreveport, Louisiana, United States, 71103
Louisiana State University Health Sciences Center, Feist-Weiller Cancer Center
Shreveport, Louisiana, United States, 71130
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
University Of Maryland and Medical Center
Baltimore, Maryland, United States, 21201
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Hudson Valley Hematology and Oncology Associates
Hawthorne, New York, United States, 10532-2168
Weill Cornell Medical Center
New York, New York, United States, 10065
Cornell Medical Center - New York Hospital
New York, New York, United States, 10021
University of Rochester Medical Center Strong Memorial Hospital
Rochester, New York, United States, 14642
New York Medical College
Valhalla, New York, United States, 10595
United States, Pennsylvania
Penn State, Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
United States, Virginia
VCU Medical Center
Richmond, Virginia, United States, 23298
Argentina
Hospital Britanico de Buenos Aires - Servicio de Reumatologia
Capital Federal, Buenos Aires, Argentina, C1280AEB
Hospital Universitario Austral
Derqui-Pilar, Buenos Aires, Argentina, 1500
Hospital Italiano de la Plata
La Plata, Buenos Aires, Argentina, 1900
Instituto Alexander Fleming
Buenos Aires, Argentina, 1426
Academia Nacional de Medicina
Buenos Aires, Argentina, 1425
Hospital Dr. Jose R. Vidal
Corrientes, Argentina, 3400
Australia, South Australia
Royal Adelaide Hospital - Pharmacist
Adelaide, South Australia, Australia, 5000
Australia
Institute of Medical and Veterinary Science
Adelaide, Australia, 5000
Royal Brisbane and Women's Hospital
Herston, Australia, QLD 4029
The Alfred Hospital
Melbourne, Australia, 3004
Haematology and Oncology Clinics of Australia
South Brisbane, Australia, 4101
Austria
Krankenhaus der Barmherzigen
Oberosterreich, Austria, 4600
Brazil
Hospital das Clinicas da UFPR
Curitiba, Parana, Brazil, 80060-900
Faculdade de Medicina do ABC
Santo Andre, SP, Brazil, 09060-650
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo - Servico de Hematologia
Sao Paulo, SP, Brazil, 05403-000
Hospital Brigadeiro
Sao Paulo, Brazil, 01401-901
Canada, Alberta
Cross Cancer Institute, Department of Medical Oncology
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
BC Cancer Agency - Cancer Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Ontario
University Health Network, Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Sir Mortimer B. Davis, Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Chile
Instituto Oncologico del Sur
Temuco, Chile
China
PLA General Hospital
Beijing, China, 100853
Peking Union Medical College Hospital
Beijing, China, 100730
The First Affiliated Hospital of College of Medicine Zhejiang Universtiy
Hangzhou, China, 310003
Ruijing Hospital
Shanghai, China, 200025
Blood Disease Hospital, Chinese Academy of Medical Science & Peking Union Medical College
Tianjin, China, 300020
Colombia
Hospital Pablo Tobon Uribe
Medellin, Antioquia, Colombia
Fundacion Santa Fe de Bogota
Bogota, Cundinamarca, Colombia
Finland
Helsinki University Central Hospital Biomedicum Helsinki
Helsinki, Finland, FIN-00029
Germany
Universitaet Mainz III. Medizinische Klinik
Mainz, RP, Germany, D-55101
Universitaetsklinikum Carl Gustav Carus
Dresden, Germany, 01307
Univeristaetsklinikum Hamburg-Eppendorf, Onkologisches Zentrum
Hamburg, Germany, 20246
III. Medizinische Klinik, Universitaetsmedizin Mannheim, CML-Studienzentrale
Mannheim, Germany, 68169
Universitätsklinikum Mannheim gGmbH
Mannheim, Germany, 68167
Hong Kong
Pamela Youde Nethersole Eastern Hospital - Department of Medicine
Chai Wan, Hong Kong
Rm 417, Blk K, Department of Medicine, Queen Mary Hospital, 102 Pokfulam Road
Hong Kong, Hong Kong
Hungary
Fovarosi Onkormanyzat Egyesitett Szent Istvan es Szent Laszlo
Budapest, Hungary, 1096
India
Christian Medical College
Vellore, Tamil Nadu, India, 632 004
Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Orbassano, Torino, Italy, 10043
Istituto di Ematologia "L. e A. Seragnoli" Policlinico Sant'Orsola Malpighi
Bologna, Italy, 40138
Azienda Ospedaliera San Gerardo
Monza, Italy, 20900
Korea, Republic of
Asan Medical Centre
Seoul, Korea, Republic of, 138-736
The Catholic University of Korea, Seoul St. Mary Hospital
Seoul, Korea, Republic of, 137-701
Mexico
Centro Oncologico Estatal ISSEMYM
Toluca, Estado de Mexico, Mexico, 50180
Hospital Universitario de Nuevo León
Monterrey, Nuevo Leon, Mexico, 64460
Netherlands
CEC
Amsterdam, Netherlands, 1081 HV
VU University Medical Center
Amsterdam, Netherlands, 1081 HV
LEC
Groningem, Netherlands, 9713 GZ
Academisch Ziekenhuis Groningen
Groningen, Netherlands, 9713 GZ
UMCG - Pharmacy
Groningen, Netherlands, 9713 AP
UMCG - Pharmacy - obsolete
Groningen, Netherlands, 9713 GZ
University Medical Center Groningen - obsolete
Groningen, Netherlands, 9713
Norway
St Olav's Hospital HFUniversitetssykehuset I TrondheimBarn
Trondheim, Norway, 7006
Peru
Hospital Nacional Edgardo Rebagliati Martins
Jesus Maria, Lima, Peru, 11
Russian Federation
State Healthcare Institution, Sverdlovsk Regional Clinical Hospital
Ekaterinburg, Russian Federation, 620102
Kirov Research Institute of Hematology and Blodd transfusion of Roszdrav - Hematology Clinic
Kirov, Russian Federation, 610027
Moscow regional Clinical Research Institute named after M.F Vladimirsky
Moscow, Russian Federation, 129110
Centre for Hematological Research
Moscow, Russian Federation, 125167
Hematological Research Centre of RAMS
Moscow, Russian Federation, 125167
Rostov State Medical University of Roszdrav
Rostov-on Don, Russian Federation, 344022
Saint Petersburg State Medical University
Saint Petersburg, Russian Federation, 197022
St-Petersburg Pavlov´s State Medical University
Saint Petersburg, Russian Federation, 197022
Singapore
Singapore General Hospital, Department of Haematology
Singapore, Singapore, 169608
South Africa
University of the free State
Bloemfontein, Free State, South Africa, 9301
Chris Hani Baragwanath Hospital
Johannesburg, Gauteng, South Africa, 2013
Wits Donald Gordon Clinical Trial Site
Johannesburg, Gauteng, South Africa, 2193
University of Witwatersrand Oncology, Donald Gordon Medical Centre, 17 + 18
Parktown, Johannesburg, South Africa, 2193
University of Cape Town
Cape Town, Western Cape, South Africa, 7925
Spain
Hospital Universitari Clinic de Barcelona
Barcelona, Catalonia, Spain, 08036
Hospital Universitario La Princesa
Madrid, Spain, 28006
Hospital Clinico Universitario de Valencia (CHUV)
Valencia, Spain, 46010
Sweden
Akademiska University Hospital
Uppsala, Sweden, 751 85
Taiwan
National Taiwan University Hospital
Taipei TOC, Taiwan, 100
United Kingdom
Freeman Hospital - Pharmacy Department
High Heaton, Newcastle Upon Tyne, United Kingdom, NE7 7DN
Freeman Hospital
Newcastle Upon Tyne, North East England, United Kingdom, NE7 7DN
Hammersmith Hospital
London, United Kingdom, W12 0HS
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00261846     History of Changes
Other Study ID Numbers: 3160A4-200, B1871006, 3160A4-200-WW, 2005-004230-40, B1871006
Study First Received: December 2, 2005
Results First Received: October 4, 2012
Last Updated: October 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Leukemia
tyrosine kinase inhibitor
philadelphia chromosome
Myeloid
Philadelphia Positive

Additional relevant MeSH terms:
Abnormal Karyotype
Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Philadelphia Chromosome
Bone Marrow Diseases
Chromosome Aberrations
Hematologic Diseases
Myeloproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Pathologic Processes
Translocation, Genetic

ClinicalTrials.gov processed this record on November 27, 2014