stop_circleTerminated/Withdrawn

Lymphoma, Mantle-Cell

Bayer Identifier:

17120

ClinicalTrials.gov Identifier:

NCT02455297

EudraCT Number:

Not Available

EU CT Number:

Not Available
Phase IIa study of copanlisib in relapsed or refractory mantle cell lymphoma (MCL)

Trial purpose

The primary objective of this study is to assess objective response rate (ORR) in patients with relapsed or refractory MCL who failed ibrutinib treatment or were unable to tolerate ibrutinib.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - Histologically confirmed MCL
    - 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
  • - Any of the following as the only site(s) of disease: palpable lymph nodes not visible on imaging studies, skin lesions, or bone marrow involvement only
    - 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

Trial summary

Enrollment Goal
4
Trial Dates
August 2015 - August 2016
Phase
Phase 2
Could I Receive a placebo
No
Products
Aliqopa (Copanlisib, BAY80-6946)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
New York, 10021, United States
Terminated
New York, 10029, United States
Terminated
Hackensack, 07601, United States
Terminated
Baltimore, 21287, United States
Terminated
Burlington, 05401, United States

Primary Outcome

  • Objective response rate (ORR)
    ORR is defined as the proportion of patients who have a best overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano response criteria in NHL 2014.
    date_rangeTime Frame:
    24 weeks
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Complete response rate (CRR)
    Defined as the proportion of patients who have a best overall response of CR during study conduct according to the criteria defined by the Lugano response criteria in NHL 2014
    date_rangeTime Frame:
    24 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Disease control rate (DCR)
    Defined as the proportion of patients who have a best response of CR, PR, or stable disease (SD)
    date_rangeTime Frame:
    24 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Progression-free survival (PFS)
    Defined as the time (in days) from the date of first administration of study treatment to radiological disease progression or death from any cause (if death occurs before radiological progression is documented). PFS for patients without radiological progression or death at the time of analysis will be censored at the last date of evaluable tumor assessment. PFS for alive patients who have no tumor assessments after baseline will be censored at day 1.
    date_rangeTime Frame:
    24 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Duration of response (DOR)
    Defined as the time (in days) from the date of first observed tumor response of CR or PR, whichever was noted earlier, to radiological disease progression or death from any cause (if death occurs before radiological progression is documented)
    date_rangeTime Frame:
    24 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Overall survival (OS)
    Defined as the time (in days) from the date of first administration of study treatment to death from any cause. The OS time for patients alive at the time of analysis will be censored at their last known alive date.
    date_rangeTime Frame:
    24 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with treatment emergent adverse events (TEAEs) as a measure of safety and tolerability
    date_rangeTime Frame:
    Approximately 7 months
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

A single-arm, open-label Phase IIa study to evaluate the efficacy and safety of copanlisib monotherapy in patients with relapsed or refractory mantle cell lymphoma (MCL), who failed ibrutinib treatment or were unable to tolerate ibrutinib
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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