Japanese Phase Ib/II Copanlisib in Relapsed, Indolent B-cell NHL

NCT02342665 | Completed Phase 1

• 1 other identifier: 17792
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 13

Brief Summary

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.

Conditions

Lymphoma Non-Hodgkin

Keywords

Non Hodgkin's Lymphomas

Outcome Measures

Primary Outcomes (4)

• Number of participants with Adverse Events

  Up to 18 months

• Intensity of AE

  The NCI Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0) will be used to assess the intensity of AE

  Up to 18 months

• 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)

  Up to 18 Years

• Recommended dose determined in the dose escalation/safety evaluation

  Up to 18 months

Study Arms (1)

Copanlisib (BAY80-6946)

EXPERIMENTAL

Dose escalation/safety evaluation cohort and objective tumor response (OR) expansion cohort

Drug: Copanlisib (BAY80-6946)

Interventions

Copanlisib (BAY80-6946) DRUG

Dosing is weekly for the first 3 weeks (on Days 1, 8, and 15) of a 28-day cycle, followed by a 1-week break (i.e., no infusion on Day 22).

Copanlisib (BAY80-6946)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (13)

Unknown Facility

Nagoya, Aichi-ken, 460-0001, Japan

Location

Unknown Facility

Nagoya, Aichi-ken, 464-8681, Japan

Location

Unknown Facility

Nagoya, Aichi-ken, 466-8560, Japan

Location

Unknown Facility

Nagoya, Aichi-ken, 466-8650, Japan

Location

Unknown Facility

Nagoya, Aichi-ken, 467-8602, Japan

Location

Unknown Facility

Maebashi, Gunma, 371-8511, Japan

Location

Unknown Facility

Kobe, Hyōgo, 650-0017, Japan

Location

Unknown Facility

Sendai, Miyagi, 980-8574, Japan

Location

Unknown Facility

Chuo-ku, Tokyo, 104-0045, Japan

Location

Unknown Facility

Koto-ku, Tokyo, 135-8550, Japan

Location

Unknown Facility

Fukuoka, 811-1395, Japan

Location

Unknown Facility

Fukuoka, 812-8582, Japan

Location

Unknown Facility

Kyoto, 602-8566, Japan

Location

Related Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

copanlisib

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2015
• First Posted: January 21, 2015
• Study Start: April 21, 2015
• Primary Completion: September 14, 2018
• Study Completion: February 10, 2022
• Last Updated: January 20, 2023

Record last verified: 2023-01

Locations

JP (13)