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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000383-15 | EudraCT Number |
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no anticipated benefit over available standard therapies
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This study is designed to investigate whether the use of copanlisib is safe, feasible and beneficial to pediatric patients with solid solid tumors or lymphoma that are recurrent or refractory to standard therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose escalation of BAY806946 in Phase 1 | Experimental | It is estimated that 2 or 3 dose cohorts may be evaluated in phase 1 of the study. Safety and MTD/RP2D dose will be evaluated in 2 age groups (< 1 year old and ≥ 1 year old). |
|
| Patients with Neuroblastoma in Phase 2 | Experimental | Recommended Phase 2 dose (RP2D) for copanlisib in pediatric patients, as defined in the Phase I part of the study, will be used. |
|
| Patients with Osteosarcoma in Phase 2 | Experimental | RP2D for copanlisib in pediatric patients, as defined in the Phase I part of the study, will be used. |
|
| Patients with Rhabdomyosarcoma in Phase 2 | Experimental | RP2D for copanlisib in pediatric patients, as defined in the Phase I part of the study, will be used. |
|
| Patients with Ewing sarcoma in Phase 2 | Experimental | RP2D for copanlisib in pediatric patients, as defined in the Phase I part of the study, will be used. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Copanlisib (BAY806946) | Drug | Copanlisib will be dosed on Day 1, Day 8, and Day 15 of every 28-day cycle. Phase 1: 2 or 3 dose cohorts may be evaluated in phase 1 of the study. Phase 2: RP2D for copanlisib in pediatric patients, as defined in the Phase I part of the study, will be used. |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: The Maximum Tolerated Dose (MTD): the Highest Dose Level of Copanlisib That Can be Given so That Not More Than 1 Out of 6 Patients Experience a DLT During the DLT Evaluation Period. | Maximum tolerated dose (MTD) for copanlisib was defined as the highest dose level where 6 patients have been treated and ≤ 1 participant experienced a DLT. This endpoint was performed on SAF. | Cycle 1 (28 days) |
| Phase 1: Number of Subjects With Dose Limiting Toxicity (DLT) | DLT was observed during first cycle of treatment, and assessed as possibly, probably or definitely related to treatment with copanlisib. The DLT observation period for the purposes of dose-escalation was the first cycle of therapy. | Cycle 1 (28 days) |
| Phase 1: Number of Subjects With Treatment-emergent Adverse Events (TEAEs) | TEAE was defined as any event arising or worsening after start of study drug administration until 30 days after the last dose of the study drug intake (end of safety follow-up). This endpoint was performed on SAF. | After the first study intervention up to 30 days after the last dose of the study drug intake (end of safety follow up), with a maximum of 145 days. |
| Phase 1: Number of Subjects With Serious Adverse Events (SAEs) | This endpoint was performed on SAF. | Up to 150 days. |
| Phase 1: Number of Participants With Treatment-related Adverse Events (AEs). | This endpoint was performed on SAF. | Up to 145 days. |
| Phase 2: Objective Response Rate (ORR) | ORR was defined separately in each indication, as the number of responders divided by the number of subjects in FAS in the indication. |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Copanlisib Maximum Drug Concentration (Cmax) | Cmax: maximum concentration after the 3rd dose in a sequence of 3 nominal doses of copanlisib. PK analysis set: All participants with at least one intake of study drug and with at least one valid measurement for copanlisib were included in the copanlisib PK analysis. | Age ≥ 6 years: Pre-dose, Post-dose on Cycle 1 Day 1 and Day 15 (1-1.25 hour (h), 1.5- 3h, 22-24h). Age < 6 years: Pre-dose, Post-dose on Cycle 1 Day 1 and Day 15 (1-1.25h, 22-24h). Cycle length is 28 days. |
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Inclusion Criteria:
Signed informed consent form by patients and/or patients' parents/legal guardians and age appropriate assent form by the patients obtained before any study specific procedure
Male or female patients from 6 months to ≤ 21 years old at the time of study enrollment
Confirmation of diagnosis:
Performance level: Lansky ≥ 50% for patients ≤ 16 years of age and Karnofsky ≥ 50% for patients > 16 years of age.
Adequate bone marrow, renal and liver function.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Alabama | Birmingham | Alabama | 35233 | United States | ||
| Children's Hospital of Orange County |
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| 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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41 participants were screened into the study (signed informed consent form (ICF)). 10 participants were screening failed. 31 participants were enrolled in the study, all 31 participants received treatment in phase 1 as the study was terminated prior to the initiation of the phase 2.
The study was conducted at 14 centers in United States between 30 APR 2018 (First participant first visit) and 1-Feb-2023 (Last participant last visit).
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| ID | Title | Description |
|---|---|---|
| FG000 | Copanlisib 28mg/m*2, Total | Copanlisib was administered Intravenous (IV) on Days 1, 8 and 15 of each 28-day treatment cycle. Treatment was continued until radiological progressive disease, unacceptable toxicity, withdrawal of consent, death or other event specified by the protocol. Copanlisib 28mg/m*2 (Total) included AMD0 (5 participants who were under the original DLT criteria) and AMD1+ (19 participants who were under the amended DLT criteria). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 5, 2020 | Sep 26, 2023 |
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|
| Data was not collected for this endpoint due to study was terminated before the initiation of phase 2. |
| Phase 2: Disease Control Rate (DCR) | The DCR was defined as the number of subjects with disease control divided by the number of subjects in FAS or per protocol set (PPS) in the indication. | Data was not collected for this endpoint due to study was terminated before the initiation of phase 2. |
| Phase 2: Progression-free Survival (PFS) | Data was not collected for this endpoint due to study was terminated before the initiation of phase 2. |
| Phase 1: Area Under the Curve (AUC(0-168)) | AUC(0-168): Area under the concentration-time curve [AUC] from 0 to 168 hours after the 3rd dose in a sequence of 3 nominal doses of copanlisib. PK analysis set: All participants with at least one intake of study drug and with at least one valid measurement for copanlisib were included in the copanlisib PK analysis. | Age ≥ 6 years: Pre-dose, Post-dose on Cycle 1 Day 1 and Day 15 (1-1.25 hour (h), 1.5- 3h, 22-24h). Age < 6 years: Pre-dose, Post-dose on Cycle 1 Day 1 and Day 15 (1-1.25h, 22-24h). Cycle length is 28 days. |
| Phase 1: Objective Response Rate (ORR) | ORR by dose cohort is defined as the number of responders divided by the number of subjects in FAS in the indication. The analysis of ORR was performed on FAS. | Up to 150 days |
| Phase 2: Duration of Response (DOR) | Data was not collected for this endpoint due to study was terminated before the initiation of phase 2. |
| Phase 2: PFS in Each Indication Except for Osteosarcoma | Data was not collected for this endpoint due to study was terminated before the initiation of phase 2. |
| Phase 2: Overall Survival (OS) | Data was not collected for this endpoint due to study was terminated before the initiation of phase 2. |
| Phase 2: Number of Participants With Treatment-emergent AEs | Data was not collected for this endpoint due to study was terminated before the initiation of phase 2. |
| Phase 2: Number of Subjects With Treatment Emergent SAEs | Data was not collected for this endpoint due to study was terminated before the initiation of phase 2. |
| Phase 2: Number of Subjects With Treatment-emergent Clinically Significant Change in Laboratory Parameters, ECGs and Vital Signs | Data was not collected for this endpoint due to study was terminated before the initiation of phase 2. |
| Orange |
| California |
| 92868-3974 |
| United States |
| The Children's Hospital | Aurora | Colorado | 80045 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010-2970 | United States |
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30322 | United States |
| Riley Hospital For Children | Indianapolis | Indiana | 46202 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Cincinnati Children's Hospital and Medical Center | Cincinnati | Ohio | 45229 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | United States |
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| FG001 | Copanlisib 35mg/m*2 | Copanlisib was administered Intravenous (IV) on Days 1, 8 and 15 of each 28-day treatment cycle. Treatment was continued until radiological progressive disease, unacceptable toxicity, withdrawal of consent, death or other event specified by the protocol. |
| Started Treatment |
|
| Terminated Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Copanlisib 28mg/m*2, Total | Copanlisib was administered Intravenous (IV) on Days 1, 8 and 15 of each 28-day treatment cycle. Treatment was continued until radiological progressive disease, unacceptable toxicity, withdrawal of consent, death or other event specified by the protocol. Copanlisib 28mg/m*2 (Total) included AMD0 (5 participants who were under the original DLT criteria) and AMD1+ (19 participants who were under the amended DLT criteria). |
| BG001 | Copanlisib 35mg/m*2 | Copanlisib was administered Intravenous (IV) on Days 1, 8 and 15 of each 28-day treatment cycle. Treatment was continued until radiological progressive disease, unacceptable toxicity, withdrawal of consent, death or other event specified by the protocol. |
| BG002 | 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| 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 | Phase 1: The Maximum Tolerated Dose (MTD): the Highest Dose Level of Copanlisib That Can be Given so That Not More Than 1 Out of 6 Patients Experience a DLT During the DLT Evaluation Period. | Maximum tolerated dose (MTD) for copanlisib was defined as the highest dose level where 6 patients have been treated and ≤ 1 participant experienced a DLT. This endpoint was performed on SAF. | Safety analysis set (SAF): The SAF population was defined as all participants with at least one intake of study drug. | Posted | Number | mg/m*2/dose | Cycle 1 (28 days) |
|
|
| ||||||||||||||||||||||||||
| Primary | Phase 1: Number of Subjects With Dose Limiting Toxicity (DLT) | DLT was observed during first cycle of treatment, and assessed as possibly, probably or definitely related to treatment with copanlisib. The DLT observation period for the purposes of dose-escalation was the first cycle of therapy. | Safety analysis set (SAF): The SAF population was defined as all participants with at least one intake of study drug. | Posted | Count of Participants | Participants | Cycle 1 (28 days) |
| ||||||||||||||||||||||||||||
| Primary | Phase 1: Number of Subjects With Treatment-emergent Adverse Events (TEAEs) | TEAE was defined as any event arising or worsening after start of study drug administration until 30 days after the last dose of the study drug intake (end of safety follow-up). This endpoint was performed on SAF. | Safety analysis set (SAF): The SAF population was defined as all participants with at least one intake of study drug. | Posted | Count of Participants | Participants | After the first study intervention up to 30 days after the last dose of the study drug intake (end of safety follow up), with a maximum of 145 days. |
| ||||||||||||||||||||||||||||
| Primary | Phase 1: Number of Subjects With Serious Adverse Events (SAEs) | This endpoint was performed on SAF. | Safety analysis set (SAF): The SAF population was defined as all participants with at least one intake of study drug. | Posted | Count of Participants | Participants | Up to 150 days. |
|
| |||||||||||||||||||||||||||
| Primary | Phase 1: Number of Participants With Treatment-related Adverse Events (AEs). | This endpoint was performed on SAF. | Safety analysis set (SAF): The SAF population was defined as all participants with at least one intake of study drug. | Posted | Count of Participants | Participants | Up to 145 days. |
|
| |||||||||||||||||||||||||||
| Primary | Phase 2: Objective Response Rate (ORR) | ORR was defined separately in each indication, as the number of responders divided by the number of subjects in FAS in the indication. | Data was not collected for this endpoint due to study was terminated before the initiation of phase 2. | Posted | Data was not collected for this endpoint due to study was terminated before the initiation of phase 2. |
|
| |||||||||||||||||||||||||||||
| Primary | Phase 2: Disease Control Rate (DCR) | The DCR was defined as the number of subjects with disease control divided by the number of subjects in FAS or per protocol set (PPS) in the indication. | Data was not collected for this endpoint due to study was terminated before the initiation of phase 2. | Posted | Data was not collected for this endpoint due to study was terminated before the initiation of phase 2. |
|
| |||||||||||||||||||||||||||||
| Primary | Phase 2: Progression-free Survival (PFS) | Data was not collected for this endpoint due to study was terminated before the initiation of phase 2. | Posted | Data was not collected for this endpoint due to study was terminated before the initiation of phase 2. |
|
| ||||||||||||||||||||||||||||||
| Secondary | Phase 1: Copanlisib Maximum Drug Concentration (Cmax) | Cmax: maximum concentration after the 3rd dose in a sequence of 3 nominal doses of copanlisib. PK analysis set: All participants with at least one intake of study drug and with at least one valid measurement for copanlisib were included in the copanlisib PK analysis. | For all participants included in the PK analysis set, copanlisib PK was analyzed using an established comprehensive population PK model with incorporation of allometric scaling by Body surface area (BSA) on copanlisib disposition parameters (clearance and volume parameters). The model with allometric scaling enables combining of treatment groups and was used to estimate copanlisib PK parameters (AUC0-168h and Cmax). | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/L | Age ≥ 6 years: Pre-dose, Post-dose on Cycle 1 Day 1 and Day 15 (1-1.25 hour (h), 1.5- 3h, 22-24h). Age < 6 years: Pre-dose, Post-dose on Cycle 1 Day 1 and Day 15 (1-1.25h, 22-24h). Cycle length is 28 days. |
|
| ||||||||||||||||||||||||||
| Secondary | Phase 1: Area Under the Curve (AUC(0-168)) | AUC(0-168): Area under the concentration-time curve [AUC] from 0 to 168 hours after the 3rd dose in a sequence of 3 nominal doses of copanlisib. PK analysis set: All participants with at least one intake of study drug and with at least one valid measurement for copanlisib were included in the copanlisib PK analysis. | For all participants included in the PK analysis set, copanlisib PK was analyzed using an established comprehensive population PK model with incorporation of allometric scaling by Body surface area (BSA) on copanlisib disposition parameters (clearance and volume parameters). The model with allometric scaling enables combining of treatment groups and was used to estimate copanlisib PK parameters (AUC0-168h and Cmax). | Posted | Geometric Mean | Geometric Coefficient of Variation | μg∙h/L | Age ≥ 6 years: Pre-dose, Post-dose on Cycle 1 Day 1 and Day 15 (1-1.25 hour (h), 1.5- 3h, 22-24h). Age < 6 years: Pre-dose, Post-dose on Cycle 1 Day 1 and Day 15 (1-1.25h, 22-24h). Cycle length is 28 days. |
|
| ||||||||||||||||||||||||||
| Secondary | Phase 1: Objective Response Rate (ORR) | ORR by dose cohort is defined as the number of responders divided by the number of subjects in FAS in the indication. The analysis of ORR was performed on FAS. | Full analysis set (FAS): All subjects with at least one intake of study drug. | Posted | Count of Participants | Participants | Up to 150 days |
|
| |||||||||||||||||||||||||||
| Secondary | Phase 2: Duration of Response (DOR) | Data was not collected for this endpoint due to study was terminated before the initiation of phase 2. | Posted | Data was not collected for this endpoint due to study was terminated before the initiation of phase 2. |
|
| ||||||||||||||||||||||||||||||
| Secondary | Phase 2: PFS in Each Indication Except for Osteosarcoma | Data was not collected for this endpoint due to study was terminated before the initiation of phase 2. | Posted | Data was not collected for this endpoint due to study was terminated before the initiation of phase 2. |
|
| ||||||||||||||||||||||||||||||
| Secondary | Phase 2: Overall Survival (OS) | Data was not collected for this endpoint due to study was terminated before the initiation of phase 2. | Posted | Data was not collected for this endpoint due to study was terminated before the initiation of phase 2. |
|
| ||||||||||||||||||||||||||||||
| Secondary | Phase 2: Number of Participants With Treatment-emergent AEs | Data was not collected for this endpoint due to study was terminated before the initiation of phase 2. | Posted | Data was not collected for this endpoint due to study was terminated before the initiation of phase 2. |
|
| ||||||||||||||||||||||||||||||
| Secondary | Phase 2: Number of Subjects With Treatment Emergent SAEs | Data was not collected for this endpoint due to study was terminated before the initiation of phase 2. | Posted | Data was not collected for this endpoint due to study was terminated before the initiation of phase 2. |
|
| ||||||||||||||||||||||||||||||
| Secondary | Phase 2: Number of Subjects With Treatment-emergent Clinically Significant Change in Laboratory Parameters, ECGs and Vital Signs | Data was not collected for this endpoint due to study was terminated before the initiation of phase 2. | Posted | Data was not collected for this endpoint due to study was terminated before the initiation of phase 2. |
|
|
After the first study intervention up to 30 days after the last dose of the study drug intake (end of safety follow up), with a maximum of 150 days. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with a maximum of 150 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Copanlisib 28mg/m*2, Total | Copanlisib was administered Intravenous (IV) on Days 1, 8 and 15 of each 28-day treatment cycle. Treatment was continued until radiological progressive disease, unacceptable toxicity, withdrawal of consent, death or other event specified by the protocol. Copanlisib 28mg/m*2 (Total) included AMD0 (5 participants who were under the original DLT criteria) and AMD1+ (19 participants who were under the amended DLT criteria). | 20 | 24 | 10 | 24 | 23 | 24 |
| EG001 | Copanlisib 35mg/m*2 | Copanlisib was administered Intravenous (IV) on Days 1, 8 and 15 of each 28-day treatment cycle. Treatment was continued until radiological progressive disease,unacceptable toxicity, withdrawal of consent, death or other event specified by the protocol. | 5 | 7 | 0 | 7 | 7 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (25.1) | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (25.1) | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (25.1) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Non-systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Vessel puncture site pain | General disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA (25.1) | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (25.1) | Non-systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA (25.1) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (25.1) | Non-systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA (25.1) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (25.1) | Non-systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA (25.1) | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (25.1) | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA (25.1) | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA (25.1) | Non-systematic Assessment |
| |
| Carbon dioxide decreased | Investigations | MedDRA (25.1) | Non-systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (25.1) | Non-systematic Assessment |
| |
| High density lipoprotein decreased | Investigations | MedDRA (25.1) | Non-systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA (25.1) | Non-systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (25.1) | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (25.1) | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (25.1) | Non-systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA (25.1) | Non-systematic Assessment |
| |
| Protein total decreased | Investigations | MedDRA (25.1) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (25.1) | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (25.1) | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (25.1) | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Hypouricaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (25.1) | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Bayer AG | 30 300139003 | clinical-trials-contact@bayer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 6, 2019 | Sep 26, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D009447 | Neuroblastoma |
| D012516 | Osteosarcoma |
| D012208 | Rhabdomyosarcoma |
| D012512 | Sarcoma, Ewing |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D012509 | Sarcoma |
| D009217 | Myosarcoma |
| D009379 | Neoplasms, Muscle Tissue |
| 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
| Preterm newborn infants (gestational age < 37 wks) |
|
| Newborns (0-27 days) |
|
| Infants and toddlers (28 days-23 months) |
|
| Children (2-11 years) |
|
| Adolescents (12-17 years) |
|
| Adults (18-64 years) |
|
| From 65-84 years |
|
| 85 years and over |
|
| 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 |
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|
| Participants |
|
|