check_circleStudy Completed

Lymphoma Non-Hodgkin

Bayer Identifier:

17792

ClinicalTrials.gov Identifier:

NCT02342665

EudraCT Number:

Not Available

EU CT Number:

Not Available
Japanese Phase Ib/II copanlisib in relapsed, indolent B-cell NHL

Trial purpose

The primary objective of this study is to assess the safety profile of copanlisib at the recommended dose (primary endpoint). The recommended dose of copanlisib for Japanese patients will be determined in the dose escalation/safety evaluation part.

Key Participants Requirements

Sex

Both

Age

20 - N/A
  • - Histologically confirmed diagnosis of indolent B-cell NHL, with histological subtype limited to the following:
    Follicular lymphoma (FL) grade 1-2-3a
    Small lymphocytic lymphoma (SLL) with absolute lymphocyte count < 5 x 109/L at the time of diagnosis and at study entry
    Lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM)
    Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal)
    - Relapsed or refractory after ≥ 2 prior lines of therapy (refractory defined as not responding to a standard regimen or progressing within 6 months of the last course of a standard regimen). Patients must have previously received rituximab and alkylating agent(s).
    - Japanese patients ≥ 20 years of age
    - ECOG performance status ≤ 2 (Eastern Cooperative Oncology Group:ECOG)
    - Life expectancy of at least 3 months
    - Adequate bone marrow, liver and renal function as assessed within 7 days before starting study treatment
    - Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (LLN) for the Institution
    - Availability of fresh or archival tumor tissue

  • - Uncontrolled hypertension (blood pressure ≥ 150/90 mmHg, defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 90 mmHg, despite optimal medical management)
    - Patients with evidence or history of bleeding diathesis. Any hemorrhage or bleeding event ≥ CTCAE Grade 3 (NCI-CTC version 4.0) within 4 weeks of start of study medication (CTCAE: Common Terminology Criteria for Adverse Events, NCI: National Cancer Institute).
    - History or concurrent condition of interstitial lung disease or severely impaired pulmonary function
    - Unresolved toxicity higher than CTCAE grade 1 attributed to any prior therapy/procedure excluding alopecia.
    - Prior treatment with PI3K inhibitors
    - Systemic corticosteroid therapy (ongoing)
    - Type I or II diabetes mellitus with HbA1c > 8.5% or fasting plasma glucose > 160 mg/dL at Screening
    - Known history of human immunodeficiency virus (HIV) infection.
    - Hepatitis B or C requiring treatment
    - Cytomegalovirus (CMV) PCR positive at baseline
    - Known lymphomatous involvement of the central nervous system

Trial summary

Enrollment Goal
25
Trial Dates
April 2015 - February 2022
Phase
Phase 1/Phase 2
Could I Receive a placebo
No
Products
Aliqopa (Copanlisib, BAY80-6946)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Chuo-ku, 104-0045, Japan
Completed
Koto-ku, 135-8550, Japan
Completed
Sendai, 980-8574, Japan
Completed
Fukuoka, 812-8582, Japan
Completed
Nagoya, 460-0001, Japan
Completed
Nagoya, 466-8560, Japan
Completed
Nagoya, 467-8602, Japan
Completed
Kyoto, 602-8566, Japan
Completed
Kobe, 650-0017, Japan
Completed
Nagoya, 466-8650, Japan
Completed
Fukuoka, 811-1395, Japan
Completed
Nagoya, 464-8681, Japan
Completed
Maebashi, 371-8511, Japan
Withdrawn
Niigata, 951-8566, Japan
Withdrawn
Minato-ku, 105-8470, Japan

Primary Outcome

  • Number of participants with Adverse Events
    date_rangeTime Frame:
    Up to 18 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Intensity of AE
    The NCI Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0) will be used to assess the intensity of AE
    date_rangeTime Frame:
    Up to 18 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Objective Tumor Response (OR)
    OR: Best response rating of complete response or partial response according to the criteria defined in the Revised Response Criteria for Malignant Lymphoma(JClin Oncol.2007 Feb)
    date_rangeTime Frame:
    Up to 18 Years
    enhanced_encryption
    Safety Issue:
    No
  • Recommended dose determined in the dose escalation/safety evaluation
    date_rangeTime Frame:
    Up to 18 months
    enhanced_encryption
    Safety Issue:
    No

Trial design

Open-label, uncontrolled, single-arm, Phase Ib/II study of intravenous copanlisib in Japanese patients with indolent B-cell Non Hodgkin’s Lymphomas relapsed after or refractory to standard therapy
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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