Phase IIa Study of Copanlisib in Relapsed or Refractory Mantle Cell Lymphoma (MCL)
NCT ID: NCT02455297
Last Updated: 2017-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
4 participants
INTERVENTIONAL
2015-08-24
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Copanlisib
Copanlisib (BAY80-6946) solution for IV infusion
Copanlisib (BAY80-6946)
Starting dose 60 mg (dose reduction due to toxicities to 45 mg allowed). Administered in slow IV bolus on days 1, 8 and 15 of each 28 day cycle until disease progression or until another criterion is met for withdrawal from study treatment.
Interventions
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Copanlisib (BAY80-6946)
Starting dose 60 mg (dose reduction due to toxicities to 45 mg allowed). Administered in slow IV bolus on days 1, 8 and 15 of each 28 day cycle until disease progression or until another criterion is met for withdrawal from study treatment.
Eligibility Criteria
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Inclusion Criteria
* Patients who have previously received treatment with ibrutinib (modified by amendment 1), including:
* Completion of at least 1 cycle of treatment with ibrutinib and confirmed evidence of disease progression or refractoriness to treatment or
* Discontinuation of ibrutinib treatment at an earlier time due to toxicity
* Measurable disease according to the Lugano Classification
* At least 28 days or 5 half-lives, whichever is shorter, from the completion of anti-cancer treatment (including, but not limited to, immunotherapy, chemotherapy, targeted therapy and biologic therapy) to the start of study treatment, excluding ibrutinib where the window may be less and at minimum 3 days (modified by amendment 1)
* Availability of fresh tumor tissue at screening
* Male or female patients ≥ 18 years old
* ECOG (Eastern Cooperative Oncology Group) performance status of ≤ 2
* Left ventricular ejection fraction (LVEF) by echocardiogram or multiple gated acquisition (MUGA) scan ≥ the lower limit of normal (LLN) for the Institution
* Adequate bone marrow, liver and renal function
Exclusion Criteria
* Current central nervous system (CNS) involvement by lymphoma
* New York Heart Association (NYHA) class III or IV heart disease
* Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months). Myocardial infarction less than 6 months before start of study treatment
* Uncontrolled arterial hypertension despite optimal medical management (per investigator's assessment) (modified by amendment 1)
* Type I or II diabetes mellitus with HbA1c \> 8.5% at screening (modified by amendment 1)
* Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before start of study treatment. However, if a patient has recovered to ECOG performance status of ≤ 2 he/she may be enrolled provided that other eligibility criteria are met
* Ongoing or active infection of Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 3
* Known history of human immunodeficiency virus (HIV) infection
* Acute or chronic hepatitis B (HBV) or hepatitis C (HCV) infection requiring concomitant treatment prohibited by this protocol (i.e.immunosuppressive therapy)
* History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function (as judged by the investigator)
* Prior treatment with PI3K inhibitor(s)
* Cytomegalovirus (CMV) PCR positive at baseline
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Baltimore, Maryland, United States
Hackensack, New Jersey, United States
New York, New York, United States
New York, New York, United States
Burlington, Vermont, United States
Countries
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Other Identifiers
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17120
Identifier Type: -
Identifier Source: org_study_id