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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002602-52 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Copanlisib (indolent NHL) | Experimental | Part A: Participants in this arm will be patients with indolent NHL. |
|
| Copanlisib (aggressive NHL) | Experimental | Part A: Participants in this arm will be patients with aggressive NHL. |
|
| Copanlisib (indolent B-cell NHL) | Experimental | Part B: Participants in this arm will be patients with indolent B-cell NHL. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Copanlisib (Aliqopa, BAY80-6946) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline up to the last patient has completed the 16 weeks of treatment |
| 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. | Baseline up to the last patient has completed the 16 weeks of treatment |
| 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. | Baseline up to the last patient has completed the 16 weeks of treatment |
| 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. | Baseline up to the last patient has completed the 16 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) Based on Independent Review-Part A | DOR was defined as the time 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 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 was evaluated only for patients with at least one tumor response of CR, CRu, or PR. Some patients may have had no report of disease progression nor death caused by disease progression until the date of the LPLV. With regards to DOR, these patients were considered as right censored at the date of their last tumor assessment after first observed tumor response. |
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Inclusion Criteria:
Indolent NHL:
Aggressive NHL:
Indolent B-cell NHL lymphoma (study part B):
Histologically confirmed diagnosis of indolent B-cell NHL, with histological subtype limited to the following:
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:
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:
Excluded medical conditions:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35213 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28633365 | Result | 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. | |
| 38226495 |
| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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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.
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Part A: Overall 125 participants were screened, of them 41 were screened but never assigned to treatment. Total 84 were assigned to treatment. Part B: Overall 213 participants were screened, of them 70 were screened but never assigned to treatment. Total 143 were assigned to treatment, of them 1 was suspected as fraudulent and excluded from analysis sets. Therefore 142 participants were evaluable.
Part A-Study enrolled participants from 41 study centers in 10 countries, between 19 NOV 2012 (first participant first visit [FPFV]) and 13 AUG 2018 (last participant last visit [LPLV]). Part B-Study enrolled participants from 81 study centers in 24 countries, between 04 NOV 2013 (FPFV) and 18 MAY 2023 (LPLV),
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A: Indolent NHL/CLL | Participants with indolent Non-Hodgkin's lymphoma/Chronic lymphocytic leukemia [iNHL/CLL] received copanlisib 0.8 milligram per kilogram (mg/kg), maximum 65 mg, intravenous (IV) infusion dosing over 1 hour in 100 milliliter (mL) normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline up to approximately 6 years |
| DOR Based on Independent Review-Part B | DOR was defined as the time 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 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 was evaluated only for patients with at least one tumor response of CR, CRu, or PR. Some patients may have had no report of disease progression nor death caused by disease progression until the date of the LPLV. With regards to DOR, these patients were considered as right censored at the date of their last tumor assessment after first observed tumor response. | Baseline up to approximately 9 years 7 months |
| DOR Based on Investigator Assessment-Part A | DOR was defined as the time 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 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 was evaluated only for patients with at least one tumor response of CR, CRu, or PR. Some patients may have had no report of disease progression nor death caused by disease progression until the date of the LPLV. With regards to DOR, these patients were considered as right censored at the date of their last tumor assessment after first observed tumor response. | Baseline up to approximately 6 years |
| DOR Based on Investigator Assessment-Part B | DOR was defined as the time 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 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 was evaluated only for patients with at least one tumor response of CR, CRu, or PR. Some patients may have had no report of disease progression nor death caused by disease progression until the date of the LPLV. With regards to DOR, these patients were considered as right censored at the date of their last tumor assessment after first observed tumor response. | Baseline up to approximately 9 years 7 months |
| Progression Free Survival (PFS) Based on Independent Review-Part A | 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). | Baseline up to approximately 6 years |
| PFS Based on Independent Review-Part B | 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). | Baseline up to approximately 9 years 7 months |
| PFS Based on Investigator Assessment-Part A | 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). | Baseline up to approximately 6 years |
| PFS Based on Investigator Assessment-Part B | 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). | Baseline up to approximately 9 years 7 months |
| Overall Survival (OS)-Part A | OS was defined as the time (in days) from the date of first administration of study treatment to death due to any cause. Patients who were alive at the date of the LPLV were censored at the minimum of the date of LPLV and the last available date of evidence that the patient was still alive. | Baseline up to approximately 6 years |
| OS-Part B | OS was defined as the time (in days) from the date of first administration of study treatment to death due to any cause. OS was defined as the time (in days) from the date of first administration of study treatment to death due to any cause. Patients who were alive at the date of the LPLV were censored at the minimum of the date of LPLV and the last available date of evidence that the patient was still alive. | Baseline up to approximately 9 years 7 months |
| 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. | Baseline up to week 16 |
| 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. | Baseline up to week 16 |
| Gilbert |
| Arizona |
| 85234 |
| United States |
| Anaheim | California | 90801 | United States |
| Aurora | Colorado | 80012 | United States |
| Englewood | Colorado | 80113 | United States |
| Fort Collins | Colorado | 80528 | United States |
| Seattle | Florida | 98101 | United States |
| Louisville | Kentucky | 40207 | United States |
| Detroit | Michigan | 48202 | United States |
| Saint Louis Park | Minnesota | 55426 | United States |
| Westbury | New York | 11590 | United States |
| Clinton | North Carolina | 2753 | United States |
| Canton | Ohio | 44718 | United States |
| San Antonio | Texas | 78229 | United States |
| Spokane | Washington | 99208-1129 | United States |
| Garran | Australian Capital Territory | 2605 | Australia |
| Linz | 4020 | Austria |
| Brussels | 1070 | Belgium |
| Bruxelles - Brussel | 1200 | Belgium |
| Ghent | 9000 | Belgium |
| Leuven | 3000 | Belgium |
| Turnhout | 2300 | Belgium |
| Wilrijk | 2610 | Belgium |
| Sofia | 1431 | Bulgaria |
| Saint John | New Brunswick | E2L 4L2 | Canada |
| Montreal | Quebec | H1T 2M4 | Canada |
| Montreal | Quebec | H3T 1E2 | Canada |
| Helsinki | 00290 | Finland |
| Oulu | 90020 | Finland |
| Tampere | 33521 | Finland |
| Turku | FIN-20521 | Finland |
| Brest | 29285 | France |
| Créteil | 94010 | France |
| La Roche-sur-Yon | 85925 | France |
| Lille | 59037 | France |
| Paris | 75475 | France |
| Pessac | 33600 | France |
| Pierre-Bénite | 69495 | France |
| Poitiers | 86021 | France |
| Rouen | 76038 | France |
| Vandœuvre-lès-Nancy | 54500 | France |
| München | Bavaria | 81377 | Germany |
| Münster | North Rhine-Westphalia | 48149 | Germany |
| Recklinghausen | North Rhine-Westphalia | 45659 | Germany |
| Mainz | Rhineland-Palatinate | 55131 | Germany |
| Dresden | Saxony | 01307 | Germany |
| Potsdam | State of Berlin | 14467 | Germany |
| Berlin | 10967 | Germany |
| Berlin | 13353 | Germany |
| Athens | 11526 | Greece |
| Hong Kong | Hong Kong |
| Shatin | MISSING | Hong Kong |
| Budapest | 1083 | Hungary |
| Budapest | 1097 | Hungary |
| Kaposvár | 7400 | Hungary |
| Galway | H91 YR71 | Ireland |
| Petah Tikva | 4941492 | Israel |
| Ramat Gan | 5262000 | Israel |
| Ẕerifin | 7030000 | Israel |
| Naples | Campania | 80131 | Italy |
| Bologna | Emilia-Romagna | 40138 | Italy |
| Rome | Lazio | 00161 | Italy |
| Brescia | Lombardy | 25123 | Italy |
| Milan | Lombardy | 20089 | Italy |
| Turin | Piedmont | 10126 | Italy |
| Christchurch | New Zealand |
| Gdynia | 81-519 | Poland |
| Krakow | 30-510 | Poland |
| Lisbon | 1093 CODEX | Portugal |
| Lisbon | 1099-023 | Portugal |
| Kemerovo | 650066 | Russia |
| Moscow | 129128 | Russia |
| Nizhny Novgorod | 603126 | Russia |
| Omsk | 644013 | Russia |
| Saint Petersburg | 197101 | Russia |
| Saratov | 410053 | Russia |
| Singapore | 169608 | Singapore |
| Singapore | 169610 | Singapore |
| Busan | Busan Gwang''yeogsi | 49201 | South Korea |
| Seoul | Seoul Teugbyeolsi | 3080 | South Korea |
| Seoul | 6351 | South Korea |
| Majadahonda | Madrid | 28222 | Spain |
| Marbella | Málaga | 29603 | Spain |
| Barcelona | 08036 | Spain |
| Madrid | 28050 | Spain |
| Seville | 41071 | Spain |
| Valencia | 46026 | Spain |
| Uddevalla | 451 80 | Sweden |
| Ankara | 06100 | Turkey (Türkiye) |
| Istanbul | 34093 | Turkey (Türkiye) |
| Izmir | 35100 | Turkey (Türkiye) |
| Izmir | 35340 | Turkey (Türkiye) |
| Cambridge | Cambridgeshire | CB2 0QQ | United Kingdom |
| Plymouth | Devon | PL6 8DH | United Kingdom |
| Southampton | Hampshire | SO16 6YD | United Kingdom |
| Harrow | London | HA1 3UJ | United Kingdom |
| Liverpool | Merseyside | L7 8XP | United Kingdom |
| Sutton | Surrey | SM2 5PT | United Kingdom |
| Birmingham | West Midlands | B9 5SS | United Kingdom |
| Leeds | LS9 7TF | United Kingdom |
| Manchester | M20 4BX | United Kingdom |
| Romford | RM7 0AG | United Kingdom |
| Derived |
| Morcos PN, Moss J, Veasy J, Hiemeyer F, Childs BH, Garmann D. Model-Based Benefit/Risk Analysis for the Copanlisib Intermittent Dosing Regimen. Clin Pharmacol Ther. 2024 May;115(5):1092-1104. doi: 10.1002/cpt.3173. Epub 2024 Jan 16. |
| 33560394 | Derived | 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. |
| FG001 | Part A: Aggressive NHL | Participants with aggressive NHL (aNHL) received copanlisib 0.8 mg/kg, maximum 65 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study. |
| FG002 | Part B: Indolent NHL | Participants with indolent B-cell NHL received copanlisib 60 mg or 0.8 mg/kg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Revised Response Criteria for Malignant Lymphoma by Cheson et al., 2007, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study. |
| COMPLETED |
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| NOT COMPLETED |
|
|
Full Analysis Set (FAS) included all participants assigned to study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A: Indolent NHL/CLL | Participants with indolent Non-Hodgkin's lymphoma/Chronic lymphocytic leukemia [iNHL/CLL] received copanlisib 0.8 milligram per kilogram (mg/kg), maximum 65 mg, intravenous (IV) infusion dosing over 1 hour in 100 milliliter (mL) normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study. |
| BG001 | Part A: Aggressive NHL | Participants with aggressive NHL (aNHL) received copanlisib 0.8 mg/kg, maximum 65 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study. |
| BG002 | Part B: Indolent NHL | Participants with indolent B-cell NHL received copanlisib 60 mg or 0.8 mg/kg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Revised Response Criteria for Malignant Lymphoma by Cheson et al., 2007, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Per protocol set included all patients treated with study drug and evaluated for ORR and had no major protocol deviation. (In Part A, for CLL patients, there was no independent assessment. Instead, the investigator assessment had been used.) | Posted | Number | 90% Confidence Interval | percentage of participants | Baseline up to the last patient has completed the 16 weeks of treatment |
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| Primary | 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. | FAS included all patients assigned to study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to the last patient has completed the 16 weeks of treatment |
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| Primary | 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. | Per protocol set included all patients treated with study drug and evaluated for ORR and had no major protocol deviation. Patients who were not evaluable for ORR and discontinued due to a drug-related toxicity, death / progression by clinical judgment before disease was re-evaluated and included. | Posted | Number | 90% Confidence Interval | percentage of participants | Baseline up to the last patient has completed the 16 weeks of treatment |
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| Primary | 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. | FAS included all patients assigned to study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to the last patient has completed the 16 weeks of treatment |
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| Secondary | Duration of Response (DOR) Based on Independent Review-Part A | DOR was defined as the time 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 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 was evaluated only for patients with at least one tumor response of CR, CRu, or PR. Some patients may have had no report of disease progression nor death caused by disease progression until the date of the LPLV. With regards to DOR, these patients were considered as right censored at the date of their last tumor assessment after first observed tumor response. | PPS included all patients with study drug administration that were evaluable for objective tumor response and had no major protocol deviation. DOR was only evaluated for patients with at least one tumor response of CR, Cru (only for Part A) or PR. | Posted | Median | 95% Confidence Interval | Days | Baseline up to approximately 6 years |
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| Secondary | DOR Based on Independent Review-Part B | DOR was defined as the time 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 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 was evaluated only for patients with at least one tumor response of CR, CRu, or PR. Some patients may have had no report of disease progression nor death caused by disease progression until the date of the LPLV. With regards to DOR, these patients were considered as right censored at the date of their last tumor assessment after first observed tumor response. | FAS included all patients assigned to study treatment. DOR was only evaluated for patients with at least one tumor response of CR, Cru (only for Part A) or PR. | Posted | Median | 95% Confidence Interval | Months | Baseline up to approximately 9 years 7 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | DOR Based on Investigator Assessment-Part A | DOR was defined as the time 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 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 was evaluated only for patients with at least one tumor response of CR, CRu, or PR. Some patients may have had no report of disease progression nor death caused by disease progression until the date of the LPLV. With regards to DOR, these patients were considered as right censored at the date of their last tumor assessment after first observed tumor response. | PPS included all patients with study drug administration that were evaluable for objective tumor response and had no major protocol deviation. DOR was only evaluated for patients with at least one tumor response of CR, Cru (only for Part A) or PR. | Posted | Median | 95% Confidence Interval | Days | Baseline up to approximately 6 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | DOR Based on Investigator Assessment-Part B | DOR was defined as the time 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 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 was evaluated only for patients with at least one tumor response of CR, CRu, or PR. Some patients may have had no report of disease progression nor death caused by disease progression until the date of the LPLV. With regards to DOR, these patients were considered as right censored at the date of their last tumor assessment after first observed tumor response. | FAS included all patients assigned to study treatment. DOR was only evaluated for patients with at least one tumor response of CR, Cru (only for Part A) or PR. | Posted | Median | 95% Confidence Interval | Months | Baseline up to approximately 9 years 7 months |
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| Secondary | Progression Free Survival (PFS) Based on Independent Review-Part A | 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). | FAS included all patients assigned to study treatment. | Posted | Median | 95% Confidence Interval | Days | Baseline up to approximately 6 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PFS Based on Independent Review-Part B | 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). | FAS included all patients assigned to study treatment. | Posted | Median | 95% Confidence Interval | Months | Baseline up to approximately 9 years 7 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PFS Based on Investigator Assessment-Part A | 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). | FAS included all patients assigned to study treatment. | Posted | Median | 95% Confidence Interval | Days | Baseline up to approximately 6 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PFS Based on Investigator Assessment-Part B | 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). | FAS included all patients assigned to study treatment. | Posted | Median | 95% Confidence Interval | Months | Baseline up to approximately 9 years 7 months |
|
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| Secondary | Overall Survival (OS)-Part A | OS was defined as the time (in days) from the date of first administration of study treatment to death due to any cause. Patients who were alive at the date of the LPLV were censored at the minimum of the date of LPLV and the last available date of evidence that the patient was still alive. | FAS included all patients assigned to study treatment. | Posted | Median | 95% Confidence Interval | Days | Baseline up to approximately 6 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | OS-Part B | OS was defined as the time (in days) from the date of first administration of study treatment to death due to any cause. OS was defined as the time (in days) from the date of first administration of study treatment to death due to any cause. Patients who were alive at the date of the LPLV were censored at the minimum of the date of LPLV and the last available date of evidence that the patient was still alive. | FAS included all patients assigned to study treatment. | Posted | Median | 95% Confidence Interval | Months | Baseline up to approximately 9 years 7 months |
|
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| Secondary | 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. | FAS included all patients assigned to study treatment. The analysis was performed by using last observation carried forward (LOCF) method. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline up to week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | FAS included all patients assigned to study treatment. The analysis was performed by using last LOCF method. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline up to week 16 |
|
After the first study intervention up to 35 days after the end of study intervention, Part A: approximately 6 years. Part B: approximately 9 years 7 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, Part A: approximately 6 years. Part B: approximately 9 years 7 months.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A: Indolent NHL/CLL | Participants with indolent Non-Hodgkin's lymphoma/Chronic lymphocytic leukemia [iNHL/CLL] received copanlisib 0.8 milligram per kilogram (mg/kg), maximum 65 mg, intravenous (IV) infusion dosing over 1 hour in 100 milliliter (mL) normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study. | 21 | 33 | 16 | 33 | 33 | 33 |
| EG001 | Part A: Aggressive NHL | Participants with aggressive NHL (aNHL) received copanlisib 0.8 mg/kg, maximum 65 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study. | 39 | 51 | 31 | 51 | 50 | 51 |
| EG002 | Part B: Indolent NHL | Participants with indolent B-cell NHL received copanlisib 60 mg or 0.8 mg/kg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Revised Response Criteria for Malignant Lymphoma by Cheson et al., 2007, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study. | 75 | 142 | 81 | 142 | 138 | 142 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Autoimmune haemolytic anaemia | Blood and lymphatic system disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Aortic valve incompetence | Cardiac disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Gallbladder obstruction | Hepatobiliary disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Cryptococcosis | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Progressive multifocal leukoencephalopathy | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Rectal abscess | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Sinusitis aspergillus | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Coronavirus infection | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Klebsiella bacteraemia | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Pneumocystis jirovecii infection | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Varicella zoster pneumonia | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Systemic infection | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Vascular device infection | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (26.0) | Non-systematic Assessment |
| |
| Afferent loop syndrome | Injury, poisoning and procedural complications | MedDRA (26.0) | Non-systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA (26.0) | Non-systematic Assessment |
| |
| Biliary-vascular fistula | Injury, poisoning and procedural complications | MedDRA (26.0) | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | Non-systematic Assessment |
| |
| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | Non-systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | Non-systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | Non-systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | Non-systematic Assessment |
| |
| Tumour flare | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | Non-systematic Assessment |
| |
| Porocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | Non-systematic Assessment |
| |
| Tumour compression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Scrotal swelling | Reproductive system and breast disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Dermatitis exfoliative generalised | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Preoperative care | Surgical and medical procedures | MedDRA (26.0) | Non-systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Superficial vein thrombosis | Vascular disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (26.0) | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Eosinophil count increased | Investigations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (26.0) | Non-systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (26.0) | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (26.0) | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Taste disorder | Nervous system disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (26.0) | Non-systematic Assessment |
|
Contract Partners (PI) shall provide to Bayer any proposed publication or oral presentation relating to the Study or the Results ("Publication") at least sixty (60) days prior to the intended submission or presentation of the Publication in order to allow Bayer to review it. If Bayer does not notify PI within forty-five (45) days of Bayer's receipt of the intended Publication, PI shall remind Bayer. If Bayer does not provide any comments within the sixty day period, PI shall be free to publish.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Bayer | +1-888-8422937 | clinical-trials-contact@bayer.com |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000589253 | copanlisib |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Exact binominal test |
P-value was based on the original patients in the aggressive arm (for the first 34 patients), not including the additional recruited patients. |
| 0.0001 |
0.0001 |
| Response rate |
| 27.08 |
| 2-Sided |
| 90 |
| 16.83 |
| 39.57 |
| Superiority or Other (legacy) |
|
|
Participants with aggressive NHL (aNHL) received copanlisib 0.8 mg/kg, maximum 65 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study.
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| OG001 | Part A: Aggressive NHL | Participants with aggressive NHL (aNHL) received copanlisib 0.8 mg/kg, maximum 65 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study. |
|
|
|
|
| OG001 | Part A: Aggressive NHL | Participants with aggressive NHL (aNHL) received copanlisib 0.8 mg/kg, maximum 65 mg, IV infusion dosing over 1 hour in 100 mL normal saline solution on Days 1, 8, and 15 of a 28-day treatment cycle until occurrence of progressive disease, as defined in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas by Cheson et al. 1999, clinical progression, unacceptable toxicity, or any other criteria meeting withdrawal from study. |
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