Back to resultsOpen-label, Uncontrolled Phase II Trial of Intravenous PI3K Inhibitor BAY80-6946 in Patients With Relapsed, Indolent or Aggressive Non-Hodgkin's Lymphomas
Primary Purpose
Lymphoma, Non-Hodgkin
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Copanlisib (Aliqopa, BAY80-6946)
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma, Non-Hodgkin focused on measuring Clinical trial, phase II, Phosphatidylinositol 3-Kinase, Class I, Non-Hodgkin's lymphoma
Eligibility Criteria
Inclusion Criteria:
Indolent NHL:
- Histologically confirmed diagnosis of follicular lymphoma (FL) grades 1, 2 or 3a, marginal zone lymphoma (including nodal or splenic marginal zone B-cell lymphoma and mucosa-associated lymphoid tissue [MALT] lymphoma), lymphoplasmacytic lymphoma/Waldenström macroglobulinemia, chronic lymphocytic leukemia (CLL).
- Relapsed after ≥ 2 prior chemotherapy- or immunotherapy-based regimens for indolent NHL, or refractory to 2 prior chemotherapy and/ or immunotherapy-based regimens.
Aggressive NHL:
- Histologically confirmed diagnosis of grade 3b follicular lymphoma (FL), transformed indolent lymphoma, diffuse large B-cell lymphoma (DLBCL), mediastinal large B-cell lymphoma, mantle cell lymphoma (MCL), peripheral T-cell lymphoma unspecified, or anaplastic large cell lymphoma primary systemic type, or angioimmunoblastic T cell lymphoma.
- Relapsed after ≥ 2 prior chemotherapy regimens, including the following: First-line treatment with standard anthracycline-containing regimen (e.g., cyclophosphamide, doxorubicin, vincristine, and prednisone or equivalent). At least 1 additional combination chemotherapy regimen. Patients relapsed after or refractory to first prior chemotherapy- and/or immunotherapy-based regimen for aggressive NHL and not eligible for high-dose regimen followed by transplant. High-dose chemotherapy, or chemoradiotherapy with autologous stem cell transplantation is considered 1 regimen. Patients with CD20 expressing neoplastic cells must have received prior rituximab, if available.
- Patients with transformed indolent lymphoma must have received at least 2 prior chemotherapy- and/or immunotherapy-based regimens
- Consent to provide fresh tumor tissue during screening
Indolent B-cell NHL lymphoma (study part B):
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 extranodal)
- 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 received Rituximab and alkylating agents.
For all patients:
- Male or female patients > 18 years of age
- ECOG performance status ≤ 2 (ECOG: Eastern Cooperative Oncology Group)
- 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 archival tumor tissue
Exclusion Criteria:
- Uncontrolled hypertension (blood pressure ≥ 150/90 mmHg despite optimal medical management)
- Patients with evidence or history of bleeding diathesis. Any hemorrhage or bleeding event ≥ CTCAE Grade 3 within 4 weeks of start of study medication (CTCAE: Common Terminology Criteria for Adverse Events).
- History or concurrent condition of interstitial lung disease
- Unresolved toxicity higher than CTCAE grade 1 (NCI-CTC version 4.0) attributed to any prior therapy/procedure excluding alopecia. (NCI: National Cancer Institute)
- Prior treatment with PI3K inhibitors
- Systemic corticosteroid therapy (ongoing)
- Hepatitis B or C. All subjects must be screened for hepatitis B and C up to 28 days prior to study drug start using the hepatitis virus panel laboratorial routine. Subjects positive for HBsAg or HBcAb will be eligible if they are negative for HBV-DNA; subjects positive for HCV IgG will be eligible if they are negative for HCV RNA.
For Part B:
- Histologically confirmed diagnosis of follicular lymphoma grade 3b or transformed disease and chronic lymphocytic leukemia (CLL)
- History or concurrent condition of interstitial lung disease or severely impaired pulmonary function
Excluded medical conditions:
- Previous or concurrent cancer that is distinct in primary site or histology from indolent B-cell NHL within 5 years prior to treatment start EXCEPT for curatively treated cervical cancer in situ, nonmelanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)].
- Hepatitis B or C. All subjects must be screened for hepatitis B and C up to 28 days prior to study drug start using the hepatitis virus panel laboratorial routine. Subjects positive for HBsAg or HBcAb will be eligible if they are negative for HBV-DNA; subjects positive for HCV IgG will be eligible if they are negative for HCV-RNA.
- Type I or II diabetes mellitus with HbA1c > 8.5% or fasting plasma glucose > 160 mg/dL at screening.
- Previous or concurrent cancer that is distinct in primary site or histology from indolent B-cell NHL within 5 years prior to treatment start EXCEPT for curatively treated cervical cancer in situ, nonmelanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)].
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Copanlisib (indolent NHL)
Copanlisib (aggressive NHL)
Copanlisib (indolent B-cell NHL)
Arm Description
Part A: Participants in this arm will be patients with indolent NHL.
Part A: Participants in this arm will be patients with aggressive NHL.
Part B: Participants in this arm will be patients with indolent B-cell NHL.
Outcomes
Primary Outcome Measures
Objective Response Rate (ORR) Based on Independent Review-Part A
Objective response rate was defined as the proportion of participants with a best response rating of complete response (CR), unconfirmed complete response (CRu) or partial response (PR), based on the Report of an International Workshop to Standardize Response Criteria for non-Hodgkins Lymphomas, Cheson, 1999, as evaluated by the Independent Response Adjudication Committee (IRAC). For chronic lymphocytic leukemia (CLL) patients Hallek criteria (2008) were used and assessed by investigator.
Objective Response Rate (ORR) Based on Independent Review-Part B
Objective response rate was defined as the proportion of participants with a best response rating of CR or PR, based on the International Working Group Revised response Criteria for Malignant Lymphoma, Cheson 2007.
ORR Based on Investigator Assessment-Part A
Objective response rate was defined as the proportion of participants with a best response rating of CR, CRu or PR, based on the Report of an International Workshop to Standardize Response Criteria for non-Hodgkins Lymphomas, Cheson, 1999. For CLL patients Hallek criteria (2008) were used and assessed by investigator.
ORR Based on Investigator Assessment-Part B
Objective response rate was defined as the proportion of participants with a best response rating of CR or PR, based on the International Working Group Revised response Criteria for Malignant Lymphoma, Cheson 2007.
Secondary Outcome Measures
Duration of Response (DOR) Based on Independent Review
Duration of response (DOR) was defined as the time (in days) from the date of the first observed tumor response of CR or PR (whichever was noted earlier) to first subsequent disease progression (either first progressive disease [PD], first clinical progression or first adverse event [AE] associated with clinical disease progression) or death caused by disease progression, if this death occurred before progression was documented. All deaths were considered as 'caused by disease progression' except deaths with the reason "other" or "AE not related to disease progression.
DOR Based on Investigator Assessment
Duration of response (DOR) was defined as the time (in days) from the date of the first observed tumor response of CR or PR (whichever was noted earlier) to first subsequent disease progression (either first progressive disease [PD], first clinical progression or first adverse event [AE] associated with clinical disease progression) or death caused by disease progression, if this death occurred before progression was documented. All deaths were considered as 'caused by disease progression' except deaths with the reason "other" or "AE not related to disease progression.
Progression Free Survival (PFS) Based on Independent Review
PFS was defined as the time (in days) from the date of the first treatment to the date of first observed PD (radiological or clinical, or first AE associated with clinical PD, whichever was earlier) or death due to any cause (if death occurred before progression was documented).
PFS Based on Investigator Assessment
PFS was defined as the time (in days) from the date of the first treatment to the date of first observed PD (radiological or clinical, or first AE associated with clinical PD, whichever was earlier) or death due to any cause (if death occurred before progression was documented).
Overall Survival (OS)
OS was defined as the time (in days) from the date of first administration of study treatment to death due to any cause.
Functional Assessment of Cancer Therapy - Lymphoma Lymphoma Subscale (FACT-Lym LymS) at Week 16 - Part B
HRQoL assessment was used to describe development of patients with copanlisib by using FACT-Lym questionnaire assessment tool. It contains 42 items (questions) covering HRQoL, common lymphoma symptoms and treatment side-effects. The FACT - General (FACT-G) questionnaire contains 27 items covering 4 core HRQoL subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The FACT-Lym also includes an Additional Concerns subscale (15 items) (FACT-Lym LymS), addressing issues typically experienced by lymphoma patients. Some of the issues covered include pain, itching, night sweats, trouble sleeping, fatigue and trouble concentrating. FACT-Lym also asks patients about lumps and swelling, fevers, infections, weight, appetite, emotional stability and treatment. Score range for the FACT-Lym LymS was 0 - 60, higher score represent less symptoms. Here in below table "n" signifies evaluable participants for the respective category.
Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Total Score at Week 16 - Part B
HRQoL assessment was used to describe development of patients with copanlisib by using FACT-Lym questionnaire assessment tool. It contains 42 items (questions) covering HRQoL, common lymphoma symptoms and treatment side-effects. The FACT - General (FACT-G) questionnaire contains 27 items covering 4 core HRQoL subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The FACT-Lym also includes an Additional Concerns subscale (15 items) (FACT-Lym LymS), addressing issues typically experienced by lymphoma patients. Some of the issues covered include pain, itching, night sweats, trouble sleeping, fatigue and trouble concentrating. FACT-Lym also asks patients about lumps and swelling, fevers, infections, weight, appetite, emotional stability and treatment. FACT-Lym total score range was 0-168, higher score indicates better HRQoL. Here, in the below table "n" signifies evaluable participants for the respective category.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01660451
Brief Title
Open-label, Uncontrolled Phase II Trial of Intravenous PI3K Inhibitor BAY80-6946 in Patients With Relapsed, Indolent or Aggressive Non-Hodgkin's Lymphomas
Official Title
Open-label, Uncontrolled Phase II Trial of Intravenous PI3K Inhibitor BAY80-6946 in Patients With Relapsed, Indolent or Aggressive Non-Hodgkin's Lymphomas
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 19, 2012 (Actual)
Primary Completion Date
June 22, 2016 (Actual)
Study Completion Date
May 18, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of the study (part A) is to evaluate the efficacy and safety of BAY80-6946 in patients with indolent or aggressive Non-Hodgkin's Lymphoma, who have progressed after standard therapy. 30 patients will be enrolled to both indolent and aggressive disease group. The objective of the study part B (CHRONOS-1) is to evaluate the efficacy and safety of BAY80-6946 in patients with relapsed/refractory follicular lymphoma. 120 patients will be enrolled in the part B of the study. Further objectives are to evaluate the pharmacokinetics and biomarkers. Quality of life will be a further objective of part B of the study.
In a cohort of 20 patients (enrolled both in part A and B) an ECG substudy will be performed to assess the potential for cardiac toxicity and QT/QTc interval prolongation of BAY80-6946.
After an up to 28-day screening period, eligible patients will start treatment with BAY80-6946 at a dose of 0.8 mg/kg (Part A) and at a dose of 60 mg (Part B).
Treatment will be continued until disease has progressed or until another criterion is met for withdrawal from study. An end-of-treatment visit will be performed within 7 days after discontinuation of study treatment. Thirty to 35 days after last study drug administration, a safety followup visit will be performed for the collection of adverse events (AEs) and concomitant medication data. Patients will be contacted quarterly to determine overall survival status up to 4 years after last patient completed treatment. Patients who discontinue study drug for reasons other than disease progression will enter the Active Assessment Follow-up period. The end of study notification to Health Authorities will be based on the completion of the collection of survival data.
The efficacy is measured by the decrease in tumor size. Tumor assessments will be done at Screening, every 8 weeks during Year 1, every 12 weeks during Year 2, and every 6 months during Year 3. Blood samples will be collected for pharmacokinetic analysis. Archival tumor tissue and blood samples will be collected for biomarker analysis (mandatory) and for central pathology review (part B), fresh biopsy tissue will also be collected if available.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Non-Hodgkin
Keywords
Clinical trial, phase II, Phosphatidylinositol 3-Kinase, Class I, Non-Hodgkin's lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
227 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Copanlisib (indolent NHL)
Arm Type
Experimental
Arm Description
Part A: Participants in this arm will be patients with indolent NHL.
Arm Title
Copanlisib (aggressive NHL)
Arm Type
Experimental
Arm Description
Part A: Participants in this arm will be patients with aggressive NHL.
Arm Title
Copanlisib (indolent B-cell NHL)
Arm Type
Experimental
Arm Description
Part B: Participants in this arm will be patients with indolent B-cell NHL.
Intervention Type
Drug
Intervention Name(s)
Copanlisib (Aliqopa, BAY80-6946)
Intervention Description
BAY 80-6946 is administered in a normal saline solution, 100 mL, intravenously over 1h. No intravenous glucose preparations should be administered on the days of infusion. 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).
Part A: The individual dose will be 0.8 mg/kg (max. 65 mg) per infusion from Cycle 1 on. The maximum dose of 65 mg should never be exceeded.
Part B: The individual dose will be 60 mg per infusion from Cycle 1 on.
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR) Based on Independent Review-Part A
Description
Objective response rate was defined as the proportion of participants with a best response rating of complete response (CR), unconfirmed complete response (CRu) or partial response (PR), based on the Report of an International Workshop to Standardize Response Criteria for non-Hodgkins Lymphomas, Cheson, 1999, as evaluated by the Independent Response Adjudication Committee (IRAC). For chronic lymphocytic leukemia (CLL) patients Hallek criteria (2008) were used and assessed by investigator.
Time Frame
Baseline up to the last patient has completed the 16 weeks of treatment
Title
Objective Response Rate (ORR) Based on Independent Review-Part B
Description
Objective response rate was defined as the proportion of participants with a best response rating of CR or PR, based on the International Working Group Revised response Criteria for Malignant Lymphoma, Cheson 2007.
Time Frame
Baseline up to the last patient has completed the 16 weeks of treatment
Title
ORR Based on Investigator Assessment-Part A
Description
Objective response rate was defined as the proportion of participants with a best response rating of CR, CRu or PR, based on the Report of an International Workshop to Standardize Response Criteria for non-Hodgkins Lymphomas, Cheson, 1999. For CLL patients Hallek criteria (2008) were used and assessed by investigator.
Time Frame
Baseline up to the last patient has completed the 16 weeks of treatment
Title
ORR Based on Investigator Assessment-Part B
Description
Objective response rate was defined as the proportion of participants with a best response rating of CR or PR, based on the International Working Group Revised response Criteria for Malignant Lymphoma, Cheson 2007.
Time Frame
Baseline up to the last patient has completed the 16 weeks of treatment
Secondary Outcome Measure Information:
Title
Duration of Response (DOR) Based on Independent Review
Description
Duration of response (DOR) was defined as the time (in days) from the date of the first observed tumor response of CR or PR (whichever was noted earlier) to first subsequent disease progression (either first progressive disease [PD], first clinical progression or first adverse event [AE] associated with clinical disease progression) or death caused by disease progression, if this death occurred before progression was documented. All deaths were considered as 'caused by disease progression' except deaths with the reason "other" or "AE not related to disease progression.
Time Frame
Baseline up to the last patient has completed the 16 weeks of treatment
Title
DOR Based on Investigator Assessment
Description
Duration of response (DOR) was defined as the time (in days) from the date of the first observed tumor response of CR or PR (whichever was noted earlier) to first subsequent disease progression (either first progressive disease [PD], first clinical progression or first adverse event [AE] associated with clinical disease progression) or death caused by disease progression, if this death occurred before progression was documented. All deaths were considered as 'caused by disease progression' except deaths with the reason "other" or "AE not related to disease progression.
Time Frame
Baseline up to the last patient has completed the 16 weeks of treatment
Title
Progression Free Survival (PFS) Based on Independent Review
Description
PFS was defined as the time (in days) from the date of the first treatment to the date of first observed PD (radiological or clinical, or first AE associated with clinical PD, whichever was earlier) or death due to any cause (if death occurred before progression was documented).
Time Frame
Baseline up to the last patient has completed the 16 weeks of treatment
Title
PFS Based on Investigator Assessment
Description
PFS was defined as the time (in days) from the date of the first treatment to the date of first observed PD (radiological or clinical, or first AE associated with clinical PD, whichever was earlier) or death due to any cause (if death occurred before progression was documented).
Time Frame
Baseline up to the last patient has completed the 16 weeks of treatment
Title
Overall Survival (OS)
Description
OS was defined as the time (in days) from the date of first administration of study treatment to death due to any cause.
Time Frame
Baseline up to the last patient has completed the 16 weeks of treatment
Title
Functional Assessment of Cancer Therapy - Lymphoma Lymphoma Subscale (FACT-Lym LymS) at Week 16 - Part B
Description
HRQoL assessment was used to describe development of patients with copanlisib by using FACT-Lym questionnaire assessment tool. It contains 42 items (questions) covering HRQoL, common lymphoma symptoms and treatment side-effects. The FACT - General (FACT-G) questionnaire contains 27 items covering 4 core HRQoL subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The FACT-Lym also includes an Additional Concerns subscale (15 items) (FACT-Lym LymS), addressing issues typically experienced by lymphoma patients. Some of the issues covered include pain, itching, night sweats, trouble sleeping, fatigue and trouble concentrating. FACT-Lym also asks patients about lumps and swelling, fevers, infections, weight, appetite, emotional stability and treatment. Score range for the FACT-Lym LymS was 0 - 60, higher score represent less symptoms. Here in below table "n" signifies evaluable participants for the respective category.
Time Frame
Baseline up to the last patient has completed the 16 weeks of treatment
Title
Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Total Score at Week 16 - Part B
Description
HRQoL assessment was used to describe development of patients with copanlisib by using FACT-Lym questionnaire assessment tool. It contains 42 items (questions) covering HRQoL, common lymphoma symptoms and treatment side-effects. The FACT - General (FACT-G) questionnaire contains 27 items covering 4 core HRQoL subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The FACT-Lym also includes an Additional Concerns subscale (15 items) (FACT-Lym LymS), addressing issues typically experienced by lymphoma patients. Some of the issues covered include pain, itching, night sweats, trouble sleeping, fatigue and trouble concentrating. FACT-Lym also asks patients about lumps and swelling, fevers, infections, weight, appetite, emotional stability and treatment. FACT-Lym total score range was 0-168, higher score indicates better HRQoL. Here, in the below table "n" signifies evaluable participants for the respective category.
Time Frame
Baseline up to the last patient has completed the 16 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Indolent NHL:
Histologically confirmed diagnosis of follicular lymphoma (FL) grades 1, 2 or 3a, marginal zone lymphoma (including nodal or splenic marginal zone B-cell lymphoma and mucosa-associated lymphoid tissue [MALT] lymphoma), lymphoplasmacytic lymphoma/Waldenström macroglobulinemia, chronic lymphocytic leukemia (CLL).
Relapsed after ≥ 2 prior chemotherapy- or immunotherapy-based regimens for indolent NHL, or refractory to 2 prior chemotherapy and/ or immunotherapy-based regimens.
Aggressive NHL:
Histologically confirmed diagnosis of grade 3b follicular lymphoma (FL), transformed indolent lymphoma, diffuse large B-cell lymphoma (DLBCL), mediastinal large B-cell lymphoma, mantle cell lymphoma (MCL), peripheral T-cell lymphoma unspecified, or anaplastic large cell lymphoma primary systemic type, or angioimmunoblastic T cell lymphoma.
Relapsed after ≥ 2 prior chemotherapy regimens, including the following: First-line treatment with standard anthracycline-containing regimen (e.g., cyclophosphamide, doxorubicin, vincristine, and prednisone or equivalent). At least 1 additional combination chemotherapy regimen. Patients relapsed after or refractory to first prior chemotherapy- and/or immunotherapy-based regimen for aggressive NHL and not eligible for high-dose regimen followed by transplant. High-dose chemotherapy, or chemoradiotherapy with autologous stem cell transplantation is considered 1 regimen. Patients with CD20 expressing neoplastic cells must have received prior rituximab, if available.
Patients with transformed indolent lymphoma must have received at least 2 prior chemotherapy- and/or immunotherapy-based regimens
Consent to provide fresh tumor tissue during screening
Indolent B-cell NHL lymphoma (study part B):
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 extranodal)
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 received Rituximab and alkylating agents.
For all patients:
Male or female patients > 18 years of age
ECOG performance status ≤ 2 (ECOG: Eastern Cooperative Oncology Group)
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 archival tumor tissue
Exclusion Criteria:
Uncontrolled hypertension (blood pressure ≥ 150/90 mmHg despite optimal medical management)
Patients with evidence or history of bleeding diathesis. Any hemorrhage or bleeding event ≥ CTCAE Grade 3 within 4 weeks of start of study medication (CTCAE: Common Terminology Criteria for Adverse Events).
History or concurrent condition of interstitial lung disease
Unresolved toxicity higher than CTCAE grade 1 (NCI-CTC version 4.0) attributed to any prior therapy/procedure excluding alopecia. (NCI: National Cancer Institute)
Prior treatment with PI3K inhibitors
Systemic corticosteroid therapy (ongoing)
Hepatitis B or C. All subjects must be screened for hepatitis B and C up to 28 days prior to study drug start using the hepatitis virus panel laboratorial routine. Subjects positive for HBsAg or HBcAb will be eligible if they are negative for HBV-DNA; subjects positive for HCV IgG will be eligible if they are negative for HCV RNA.
For Part B:
Histologically confirmed diagnosis of follicular lymphoma grade 3b or transformed disease and chronic lymphocytic leukemia (CLL)
History or concurrent condition of interstitial lung disease or severely impaired pulmonary function
Excluded medical conditions:
Previous or concurrent cancer that is distinct in primary site or histology from indolent B-cell NHL within 5 years prior to treatment start EXCEPT for curatively treated cervical cancer in situ, nonmelanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)].
Hepatitis B or C. All subjects must be screened for hepatitis B and C up to 28 days prior to study drug start using the hepatitis virus panel laboratorial routine. Subjects positive for HBsAg or HBcAb will be eligible if they are negative for HBV-DNA; subjects positive for HCV IgG will be eligible if they are negative for HCV-RNA.
Type I or II diabetes mellitus with HbA1c > 8.5% or fasting plasma glucose > 160 mg/dL at screening.
Previous or concurrent cancer that is distinct in primary site or histology from indolent B-cell NHL within 5 years prior to treatment start EXCEPT for curatively treated cervical cancer in situ, nonmelanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)].
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35213
Country
United States
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
City
Anaheim
State/Province
California
ZIP/Postal Code
90801
Country
United States
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
City
Port Saint Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55426
Country
United States
City
Westbury
State/Province
New York
ZIP/Postal Code
11590
Country
United States
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208-1129
Country
United States
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
City
Linz
ZIP/Postal Code
4020
Country
Austria
City
Anderlecht
ZIP/Postal Code
1070
Country
Belgium
City
Bruxelles - Brussel
ZIP/Postal Code
1200
Country
Belgium
City
Gent
ZIP/Postal Code
9000
Country
Belgium
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
City
Turnhout
ZIP/Postal Code
2300
Country
Belgium
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
City
Oulu
ZIP/Postal Code
90020
Country
Finland
City
Tampere
ZIP/Postal Code
33521
Country
Finland
City
Turku
ZIP/Postal Code
FIN-20521
Country
Finland
City
Brest
ZIP/Postal Code
29285
Country
France
City
Creteil
ZIP/Postal Code
94010
Country
France
City
La Roche Sur Yon
ZIP/Postal Code
85925
Country
France
City
Lille
ZIP/Postal Code
59037
Country
France
City
PARIS cedex
ZIP/Postal Code
75475
Country
France
City
Pessac
ZIP/Postal Code
33600
Country
France
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
City
Poitiers
ZIP/Postal Code
86021
Country
France
City
Rouen
ZIP/Postal Code
76038
Country
France
City
Vandoeuvre-les-nancy
ZIP/Postal Code
54500
Country
France
City
München
State/Province
Bayern
ZIP/Postal Code
81377
Country
Germany
City
Potsdam
State/Province
Berlin
ZIP/Postal Code
14467
Country
Germany
City
Münster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
City
Recklinghausen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45659
Country
Germany
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
City
Berlin
ZIP/Postal Code
10967
Country
Germany
City
Berlin
ZIP/Postal Code
13353
Country
Germany
City
Athens
ZIP/Postal Code
11526
Country
Greece
City
Hong Kong
Country
Hong Kong
City
Shatin
Country
Hong Kong
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
City
Kaposvar
ZIP/Postal Code
7400
Country
Hungary
City
Galway
ZIP/Postal Code
H91 YR71
Country
Ireland
City
Petach Tikva
ZIP/Postal Code
4941492
Country
Israel
City
Ramat Gan
ZIP/Postal Code
5262000
Country
Israel
City
Zerifin
ZIP/Postal Code
7030000
Country
Israel
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
City
Roma
State/Province
Lazio
ZIP/Postal Code
00161
Country
Italy
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25123
Country
Italy
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20089
Country
Italy
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
City
Busan
State/Province
Busan Gwang''yeogsi
ZIP/Postal Code
49201
Country
Korea, Republic of
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
03080
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
City
Christchurch
Country
New Zealand
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
City
Krakow
ZIP/Postal Code
30-510
Country
Poland
City
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
City
Kemerovo
ZIP/Postal Code
650066
Country
Russian Federation
City
Moscow
ZIP/Postal Code
129128
Country
Russian Federation
City
Nizhny Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
City
Saratov
ZIP/Postal Code
410053
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
197101
Country
Russian Federation
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
City
Marbella
State/Province
Málaga
ZIP/Postal Code
29603
Country
Spain
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Madrid
ZIP/Postal Code
28050
Country
Spain
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
City
Valencia
ZIP/Postal Code
46026
Country
Spain
City
Uddevalla
ZIP/Postal Code
451 80
Country
Sweden
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
City
Plymouth
State/Province
Devon
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
City
Harrow
State/Province
London
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
City
Liverpool
State/Province
Merseyside
ZIP/Postal Code
L7 8XP
Country
United Kingdom
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B9 5SS
Country
United Kingdom
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
City
Romford
ZIP/Postal Code
RM7 0AG
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Citations:
PubMed Identifier
28633365
Citation
Dreyling M, Morschhauser F, Bouabdallah K, Bron D, Cunningham D, Assouline SE, Verhoef G, Linton K, Thieblemont C, Vitolo U, Hiemeyer F, Giurescu M, Garcia-Vargas J, Gorbatchevsky I, Liu L, Koechert K, Pena C, Neves M, Childs BH, Zinzani PL. Phase II study of copanlisib, a PI3K inhibitor, in relapsed or refractory, indolent or aggressive lymphoma. Ann Oncol. 2017 Sep 1;28(9):2169-2178. doi: 10.1093/annonc/mdx289.
Results Reference
result
PubMed Identifier
33560394
Citation
Panayiotidis P, Follows GA, Mollica L, Nagler A, Ozcan M, Santoro A, Stevens D, Trevarthen D, Hiemeyer F, Garcia-Vargas J, Childs BH, Zinzani PL, Dreyling M. Efficacy and safety of copanlisib in patients with relapsed or refractory marginal zone lymphoma. Blood Adv. 2021 Feb 9;5(3):823-828. doi: 10.1182/bloodadvances.2020002910.
Results Reference
derived
Links:
URL
https://clinicaltrials.bayer.com/
Description
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.
Learn more about this trial
Open-label, Uncontrolled Phase II Trial of Intravenous PI3K Inhibitor BAY80-6946 in Patients With Relapsed, Indolent or Aggressive Non-Hodgkin's Lymphomas
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