NCT00849654 on 2009_02_23: ClinicalTrials.gov Archive
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`Page 1 of 4
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`← History of this study
`↑ Current version of this study
`View of NCT00849654 on 2009_02_23
`This study has duplicate: NCT01177878
`
`ClinicalTrials Identifier: NCT00849654
`Updated:
`2009_02_23
`
`Descriptive Information
`Brief title
`
`Official title
`
`Study of the Safety and Tolerability of PCI-32765 in Patients
`With Recurrent B Cell Lymphoma
`Phase I Dose-Escalation Study of Bruton's Tyrosine Kinase
`(Btk) Inhibitor PCI-32765 in Recurrent B Cell Lymphoma
`
`Brief summary
`The purpose of this study is to establish the safety and optimal dose of orally
`administered PCI-32765 in patients with recurrent B cell lymphoma.
`Detailed description
`Phase
`Study type
`Study design
`Study design
`Study design
`Study design
`Study design
`Study design
`Primary outcome
`
`Phase 1
`Interventional
`Treatment
`Non-Randomized
`Open Label
`Uncontrolled
`Single Group Assignment
`Safety Study
`Measure: Dose limiting toxicity assessment for each patient.
`Time Frame: At the end of the first 35 day cycle
`Safety Issue? Yes
`Measure: Adverse events
`Time Frame: 30 days after last dose of study drug
`Safety Issue? Yes
`Measure: Pharmacokinetic/ Pharmacodynamic assessments
`Time Frame: during Cycle 1
`Safety Issue? No
`Measure: Tumor response
`Time Frame: at the end of Cycles 2, 4, and 6
`Safety Issue? No
`36 (Anticipated)
`B-Cell Lymphoma
`
`Primary outcome
`
`Primary outcome
`
`Secondary outcome
`
`Enrollment
`Condition
`
`https://clinicaltrials.gov/archive/NCT00849654/2009_02_23
`
`3/12/2015
`
`Coalition for Affordable Drugs IV LLC – Exhibit 1002
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`

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`NCT00849654 on 2009_02_23: ClinicalTrials.gov Archive
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`Condition
`Condition
`Arm/Group
`
`Intervention
`
`B-Cell Leukemia
`Bruton's Tyrosine Kinase
`Arm Label: PCI-32765 Experimental
`
`Drug: PCI-32765 Arm Label: PCI-32765
`
`PCI-32765 will be administered in 1.25, 2.5, 5.0, 8.3, 12.5,
`and 17.5 mg/kg/d dose cohorts orally once per day for 28
`days followed by a 7 day rest period. Six patients will be
`enrolled in each dosing cohort. If ≥ 2 DLTs occur in any
`cohort, the MTD will be established as the previous dosing
`cohort. If MTD is not reached, dosing levels may be
`increased beyond 17.5 mg/kg/d by 33% increments. The
`study will continue until the MTD has been established.
`Patients who do not experience DLT during Cycle 1 may
`continue with additional cycles of 28 day PCI-32765
`treatment followed by a 7 day rest period for a maximum of
`six cycles provided that there is no disease progression or
`DLT.
`http://www.pharmacyclics.com
`
`URL
`See also
`
`Recruiting
`2009-02
`2010-02 (Anticipated)
`
`Recruitment Information
`Status
`Start date
`Primary completion
`date
`Criteria
`Inclusion Criteria:
`• Women and men ≥ 18 years of age. There is no experience with this drug in a
`pediatric population.
`• Body weight ≥ 40 kg.
`• Recurrent surface immunoglobulin positive B cell non-Hodgkin's lymphoma
`(according to WHO classification) including small lymphocytic lymphoma/chronic
`lymphocytic leukemia (SLL/CLL).
`• Bi-dimensional measurable disease (≥ 2 cm diameter or for CLL ≥ 4000
`leukemia cells/mm3).
`• Have failed ≥ 1 previous treatment for lymphoma and no standard therapy is
`available. Patients with diffuse large B cell lymphoma must have failed, refused
`or be ineligible for autologous stem cell transplant.
`• ECOG performance status of ≤ 1.
`• Ability to swallow oral capsules without difficulty.
`• Willing and able to sign a written informed consent.
`
`Exclusion Criteria:
` - More than four prior systemic therapies (not counting maintenance rituximab).
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`https://clinicaltrials.gov/archive/NCT00849654/2009_02_23
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`3/12/2015
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`Salvage therapy/conditioning regimen leading up to autologous bone marrow
`transplantation is considered to be one regimen.
`• Prior allogeneic bone marrow transplant.
`• Immunotherapy, chemotherapy, radiotherapy or experimental therapy within 4
`weeks before first day of study drug dosing.
`• Major surgery within 4 weeks before first day of study drug dosing.
`• CNS involvement by lymphoma.
`• Active opportunistic infection or treatment for opportunistic infection within 4
`weeks before first day of study drug dosing.
`• History of malabsorption.
`• Laboratory abnormalities:
`• Creatinine > 1.5 × institutional upper limit of normal (ULN)
`• Total bilirubin > 1.5 x institutional ULN (unless elevated from documented
`Gilbert's syndrome)
`• AST or ALT > 2.5 × institutional ULN
`• Platelet count < 75,000/µL
`• Absolute neutrophil count (ANC) < 1500/µL.
`• Uncontrolled illness including but not limited to: ongoing or active infection,
`symptomatic congestive heart failure (New York Heart Association Class III or
`IV heart failure), unstable angina pectoris, cardiac arrhythmia, and psychiatric
`illness that would limit compliance with study requirements.
`• Risk factors for, or use of medications known to prolong QTc interval or that
`may be associated with Torsades de Pointes within 7 days of treatment start
`(see Appendix C).
`• QTc prolongation (defined as a QTc ≥ 450 msecs) or other significant ECG
`abnormalities including 2nd degree AV block type II, 3rd degree AV block, or
`bradycardia (ventricular rate less than 50 beats/min). If the screening ECG has
`a QTc ≥ 450 msecs, the ECG can be submitted for a centralized, cardiologic
`evaluation.
`• History of myocardial infarction, acute coronary syndromes (including unstable
`angina), coronary angioplasty and/or stenting within the past 6 months.
`• Known HIV infection.
`• Other medical or psychiatric illness or organ dysfunction which, in the opinion
`of the investigator, would either compromise the patient's safety or interfere with
`the evaluation of the safety of the study agent.
`• Pregnant or lactating women (female patients of child-bearing potential must
`have a negative serum pregnancy test within 14 days of first day of drug dosing,
`or, if positive, a pregnancy ruled out by ultrasound).
`• Women of child-bearing potential or sexually active men, unwilling to use
`adequate contraceptive protection during the course of the study.
`• History of prior cancer < 5 years ago, except for basal cell or squamous cell
`carcinoma of the skin, cervical cancer in situ or other in situ carcinomas.
`Gender
`Both
`Minimum age
`18 Years
`Healthy volunteers
`No
`
`Administrative Data
`Organization name
`
`Pharmacyclics
`
`https://clinicaltrials.gov/archive/NCT00849654/2009_02_23
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`3/12/2015
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`Organization study ID PCYC-04753
`Sponsor
`Pharmacyclics
`Health Authority
`United States: Food and Drug Administration
`
`https://clinicaltrials.gov/archive/NCT00849654/2009_02_23
`
`3/12/2015
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