Trial Outcomes & Findings for Nilotinib Roll-over Protocol for Patients in Novartis-sponsored Nilotinib Study and Benefiting From Nilotinib Treatment (NCT NCT01863745)
NCT ID: NCT01863745
Last Updated: 2024-08-19
Results Overview
Number of participants with adverse events (AEs) (any AE regardless of seriousness), serious adverse events (SAEs), Fatal SAEs and treatment related AEs.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
Results posted on
2024-08-19
Participant Flow
Participants took part in 11 investigative sites in Japan.
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Disease Progression
|
9
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Death
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Nilotinib Roll-over Protocol for Patients in Novartis-sponsored Nilotinib Study and Benefiting From Nilotinib Treatment
Baseline characteristics by cohort
| Measure |
Nilotinib
n=15 Participants
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.
|
|---|---|
|
Age, Continuous
|
64.5 years
STANDARD_DEVIATION 13.39 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.Population: The Safety Set included all participants who received at least one dose of Nilotinib.
Number of participants with adverse events (AEs) (any AE regardless of seriousness), serious adverse events (SAEs), Fatal SAEs and treatment related AEs.
Outcome measures
| Measure |
Nilotinib
n=15 Participants
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.
|
|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Adverse Events
|
13 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs-Treatment-related
|
8 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Serious Adverse Events
|
9 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs-Treatment-related
|
3 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Fatal SAEs
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Fatal SAEs-Treatment-related
|
0 Participants
|
Adverse Events
Nilotinib
Serious events: 9 serious events
Other events: 12 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Nilotinib
n=15 participants at risk
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.
|
|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
13.3%
2/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Eye disorders
Cataract
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Gastrointestinal disorders
Ileus
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Nervous system disorders
Cerebellar infarction
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Nervous system disorders
Cerebrovascular insufficiency
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Nervous system disorders
Thrombotic cerebral infarction
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
Other adverse events
| Measure |
Nilotinib
n=15 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
13.3%
2/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Cardiac disorders
Angina pectoris
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Ear and labyrinth disorders
Vertigo
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Eye disorders
Cataract
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Eye disorders
Keratitis
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Eye disorders
Polypoidal choroidal vasculopathy
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Gastrointestinal disorders
Ascites
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Gastrointestinal disorders
Constipation
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Gastrointestinal disorders
Dental caries
|
13.3%
2/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Gastrointestinal disorders
Enteritis
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Gastrointestinal disorders
Subileus
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
General disorders
Face oedema
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
General disorders
Fatigue
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
General disorders
Generalised oedema
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
General disorders
Malaise
|
13.3%
2/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
General disorders
Non-cardiac chest pain
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
General disorders
Oedema peripheral
|
26.7%
4/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
General disorders
Pyrexia
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
13.3%
2/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Infections and infestations
Anisakiasis
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Infections and infestations
Influenza
|
20.0%
3/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Infections and infestations
Nasopharyngitis
|
33.3%
5/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Infections and infestations
Pneumonia
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Investigations
Alanine aminotransferase increased
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Investigations
Amylase increased
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Investigations
Aspartate aminotransferase increased
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Investigations
Blood lactate dehydrogenase increased
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Investigations
Gamma-glutamyltransferase increased
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
3/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Psychiatric disorders
Persecutory delusion
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Skin and subcutaneous tissue disorders
Palmoplantar keratoderma
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Vascular disorders
Arterial stenosis
|
6.7%
1/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
|
Vascular disorders
Hypertension
|
13.3%
2/15 • Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER