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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-000061-20 | EudraCT Number |
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Due to strategic company decisions, the development of anetumab ravtansine was stopped.
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The purpose of this study is to enable patients with solid tumors, who received anetumab ravtansine in a Bayer-sponsored clinical trial, to continue treatment after their respective study has been closed. The patients will be observed to collect information on how safe and efficient the drug is.
The primary objective of the study is to collect long-term safety information on anetumab ravtansine and to enable patients, who received an anetumab ravtansine-containing treatment in any Bayer-sponsored anetumab ravtansine parent study, to continue the treatment. The secondary objective is to further investigate the efficacy of the drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cancer patients | Experimental | Adult patients with solid cancer who received anetumab-ravtansine treatment in a completed Bayer study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY94-9343 (Anetumab ravtansine) | Drug | BAY94-9343 (Anetumab ravtansine) will be administered as specified in the parent studies |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With TEAEs, TESAEs and Drug-related TEAEs and TESAEs | Treatment emergent adverse events (TEAEs) were defined as AEs starting or worsening during the treatment period. The treatment period extended from the first date of study treatment in this study until the safety follow-up (30 days after the last administration of study treatment). TESAEs: Treatment emergent serious adverse events. | Approximately 3 years (from first study treatment until safety follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival (OS) defined as the time from first treatment in this study until death from any cause. Data on survival were collected by the site. Time frame was reduced due to early termination of the study. Table reports Kaplan-Meier median with Brookmeyer-Crowley confidence intervals. Number (%) of participants with event: 5 (55.6%) and Number (%) of participants censored: 4 (44.4%). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States | ||
| National Cancer Institute - Maryland |
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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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A total of 10 participants were screened in this study; of whom 9 participants started study treatment and 1 participant was a screening failure.
The study was conducted at 7 study centers in 4 countries worldwide between 03-Jun-2019 (first participant first visit) and 18-May-2022 (last participant last visit). Entering participants had to have been treated with anetumab ravtansine in an applicable Bayer sponsored anetumab ravtansine parent study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Anetumab Ravtansine | Adult participants with solid tumors who received anetumab-ravtansine treatment as monotherapy, or in combination with gemcitabine in an applicable Bayer-sponsored anetumab ravtansine study. 8 participants received anetumab ravtansine monotherapy and 1 participant received anetumab ravtansine in combination with gemcitabine. Pooled results were reported. |
| 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 | Jun 18, 2019 | Apr 28, 2023 |
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| Approximately 3 years (from first study treatment until safety follow-up) |
| Bethesda |
| Maryland |
| 20892 |
| United States |
| Sarah Cannon Cancer Center | Nashville | Tennessee | 37203 | United States |
| Mary Crowley Medical Research Center | Dallas | Texas | 75230 | United States |
| Hôpital de la Timone - Marseille | Marseille | 13385 | France |
| ASST Grande Ospedale Metropolitano Niguarda | Milan | Lombardy | 20162 | Italy |
| Samodzielny Publiczny Wojewodzki Szpital Zespolony | Szczecin-Zdunowo | 70-891 | Poland |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Anetumab Ravtansine | Adult participants with solid tumors who received anetumab-ravtansine treatment as monotherapy, or in combination with gemcitabine in an applicable Bayer-sponsored anetumab ravtansine study. 8 participants received anetumab ravtansine monotherapy and 1 participant received anetumab ravtansine in combination with gemcitabine. Pooled results were reported. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity | Count of Participants | Participants |
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| 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 | Number of Participants With TEAEs, TESAEs and Drug-related TEAEs and TESAEs | Treatment emergent adverse events (TEAEs) were defined as AEs starting or worsening during the treatment period. The treatment period extended from the first date of study treatment in this study until the safety follow-up (30 days after the last administration of study treatment). TESAEs: Treatment emergent serious adverse events. | Posted | Count of Participants | Participants | Approximately 3 years (from first study treatment until safety follow-up) |
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| Secondary | Overall Survival | Overall survival (OS) defined as the time from first treatment in this study until death from any cause. Data on survival were collected by the site. Time frame was reduced due to early termination of the study. Table reports Kaplan-Meier median with Brookmeyer-Crowley confidence intervals. Number (%) of participants with event: 5 (55.6%) and Number (%) of participants censored: 4 (44.4%). | Posted | Median | 95% Confidence Interval | Months | Approximately 3 years (from first study treatment until safety follow-up) |
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For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the all-cause mortality: considering all deaths that occurred at any time during the study before the last contact, up to approximately 3 years.
Per the Statistical Analysis Plan, pooled ("by overall") results were reported and no differentiation on treatment of anetumab-ravtansine as monotherapy or in combination with gemcitabine.
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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 | Anetumab Ravtansine | Adult participants with solid tumors who received anetumab-ravtansine treatment as monotherapy, or in combination with gemcitabine in an applicable Bayer-sponsored anetumab ravtansine study. 8 participants received anetumab ravtansine monotherapy and 1 participant received anetumab ravtansine in combination with gemcitabine. Pooled results were reported. | 5 | 9 | 2 | 9 | 9 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Restrictive cardiomyopathy | Cardiac disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Urosepsis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Pericardial effusion | Cardiac disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Restrictive cardiomyopathy | Cardiac disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Hyperthyroidism | Endocrine disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Cataract | Eye disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Keratitis | Eye disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Corneal disorder | Eye disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Corneal epithelial microcysts | Eye disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
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| Skin infection | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
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| Corneal abrasion | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
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| Foot fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
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| Activated partial thromboplastin time prolonged | Investigations | MedDRA 25.0 | Non-systematic Assessment |
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| Amylase increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
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| Blood thyroid stimulating hormone increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
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| Lipase increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
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| Weight decreased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
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| Transaminases increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
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| Schirmer's test abnormal | Investigations | MedDRA 25.0 | Non-systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
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| Cachexia | Metabolism and nutrition disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Non-systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Peripheral motor neuropathy | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Gynaecomastia | Reproductive system and breast disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 25.0 | Non-systematic Assessment |
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Due to the small sample size and heterogeneous population, survival distributions and the extent of long-term survival in the applicable populations cannot be reliably estimated from the study results.
Overall results were reported. Pooling was done because there is only a single patient treated with combination and no summary tables on a single patient.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Bayer AG | (+)1-888-84 22937 | clinical-trials-contact@bayer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 7, 2022 | Apr 28, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008654 | Mesothelioma |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018301 | Neoplasms, Mesothelial |
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| ID | Term |
|---|---|
| C000595240 | anetumab ravtansine |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
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| Any study drug-related Serious TEAE |
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