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The purpose of this study is to collect and assess long-term safety of nilotinib in patients who are on nilotinib treatment in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs study and are benefiting from the treatment as judged by the investigator.
This was an open label, multi-center, phase II study to collect and assess long-term safety of nilotinib to patients treated in Novartis sponsored clinical studies (NCT00785785 and NCT00718562) and who were benefiting from treatment with nilotinib.
There was no screening period for this study. At the enrolment visit the patient was consented to the study and eligible patients started their treatment with nilotinib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nilotinib | Experimental | The starting dose of nilotinib was same as the last dose given in the parent nilotinib study. After this, the dose of nilotinib was based on the investigator's judgment. The total daily dose was up to 800 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nilotinib | Drug | Nilotinib was administered daily as hard gelatin capsules for oral use. The starting dose of nilotinib was same as the last dose given in the parent nilotinib study. After this, the dose of nilotinib was based on the investigator's judgment. The total daily dose was up to 800 mg. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of participants with adverse events (AEs) (any AE regardless of seriousness), serious adverse events (SAEs), Fatal SAEs and treatment related AEs. | Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Nagoya | Aichi-ken | 464 8681 | Japan | ||
| Novartis Investigative Site |
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
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There was no screening period for this study. At the enrolment visit the patient was consented to the study and eligible participants started their treatment with nilotinib. The parents nilotinib studies are CAMN107G2301 and CAMN107D1201.
Participants took part in 11 investigative sites in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nilotinib | The starting dose of nilotinib was same as the last dose given in the parent nilotinib study. After this, the dose of nilotinib was based on the investigator's judgment. The total daily dose was up to 800 mg. |
| 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 | Apr 5, 2018 | Jul 26, 2024 |
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|
| Kashiwa |
| Chiba |
| 277 8577 |
| Japan |
| Novartis Investigative Site | Gifu | Gifu | 501-1194 | Japan |
| Novartis Investigative Site | Sapporo | Hokkaido | 060 8648 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 241-8515 | Japan |
| Novartis Investigative Site | Kumamoto | Kumamoto | 860-8556 | Japan |
| Novartis Investigative Site | Sendai | Miyagi | 980 8574 | Japan |
| Novartis Investigative Site | Kurashiki | Okayama-ken | 701-0192 | Japan |
| Novartis Investigative Site | Osaka | Osaka | 540-0006 | Japan |
| Novartis Investigative Site | Suita | Osaka | 565 0871 | Japan |
| Novartis Investigative Site | Chuo Ku | Tokyo | 104 0045 | Japan |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Nilotinib | The starting dose of nilotinib was same as the last dose given in the parent nilotinib study. After this, the dose of nilotinib was based on the investigator's judgment. The total daily dose was up to 800 mg. |
| 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 |
| ||||||||||||||||||
| Race/Ethnicity, Customized | 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 Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of participants with adverse events (AEs) (any AE regardless of seriousness), serious adverse events (SAEs), Fatal SAEs and treatment related AEs. | The Safety Set included all participants who received at least one dose of Nilotinib. | Posted | Count of Participants | Participants | Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years. |
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Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
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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 | Nilotinib | The starting dose of nilotinib was same as the last dose given in the parent nilotinib study. After this, the dose of nilotinib was based on the investigator's judgment. The total daily dose was up to 800 mg. | 1 | 15 | 9 | 15 | 12 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
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| Cataract | Eye disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Small intestinal haemorrhage | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.1) | Systematic Assessment |
| |
| Cerebellar infarction | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
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| Cerebrovascular insufficiency | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
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| Thrombotic cerebral infarction | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA (26.1) | Systematic Assessment |
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| Cataract | Eye disorders | MedDRA (26.1) | Systematic Assessment |
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| Keratitis | Eye disorders | MedDRA (26.1) | Systematic Assessment |
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| Polypoidal choroidal vasculopathy | Eye disorders | MedDRA (26.1) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
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| Abdominal pain lower | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
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| Dental caries | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
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| Enteritis | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
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| Subileus | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
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| Face oedema | General disorders | MedDRA (26.1) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (26.1) | Systematic Assessment |
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| Generalised oedema | General disorders | MedDRA (26.1) | Systematic Assessment |
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| Malaise | General disorders | MedDRA (26.1) | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA (26.1) | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA (26.1) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (26.1) | Systematic Assessment |
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| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (26.1) | Systematic Assessment |
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| Anisakiasis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
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| Tooth fracture | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA (26.1) | Systematic Assessment |
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| Amylase increased | Investigations | MedDRA (26.1) | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA (26.1) | Systematic Assessment |
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| Blood lactate dehydrogenase increased | Investigations | MedDRA (26.1) | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA (26.1) | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
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| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
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| Persecutory delusion | Psychiatric disorders | MedDRA (26.1) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
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| Palmoplantar keratoderma | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
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| Arterial stenosis | Vascular disorders | MedDRA (26.1) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (26.1) | Systematic Assessment |
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The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | + 1 862 778 8300 | novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 20, 2023 | Jul 26, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D046152 | Gastrointestinal Stromal Tumors |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C498826 | nilotinib |
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| Title | Measurements |
|---|---|
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| SAEs-Treatment-related |
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| Fatal SAEs |
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| Fatal SAEs-Treatment-related |
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