Gastrointestinal Stromal Tumors
Conditions
Keywords
gastrointestinal stromal tumors, gastrointestinal,, stromal,, tumors,, GIST,, AMN107,, nilotinib
Brief summary
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.
Detailed description
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.
Interventions
DRUGnilotinib
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.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 84 Years
Healthy volunteers
No
Inclusion criteria
* Patient is currently enrolled in a Novartis-sponsored, Clinical study receiving nilotinib and benefiting from the treatment with nilotinib, as determined by the investigator
Exclusion criteria
* Patient has been permanently discontinued from nilotinib treatment in the parent study due to unacceptable toxicity, non-compliance to study procedures, withdrawal of consent or any other reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years. | Number of participants with adverse events (AEs) (any AE regardless of seriousness), serious adverse events (SAEs), Fatal SAEs and treatment related AEs. |
Countries
Japan
Participant flow
Recruitment details
Participants took part in 11 investigative sites in Japan.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Death | 1 |
| Overall Study | Disease Progression | 9 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Nilotinib |
|---|---|
| Age, Continuous | 64.5 years STANDARD_DEVIATION 13.39 |
| Race/Ethnicity, Customized Japanese | 15 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 15 |
| other Total, other adverse events | 12 / 15 |
| serious Total, serious adverse events | 9 / 15 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nilotinib | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Adverse Events | 13 Participants |
| Nilotinib | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs-Treatment-related | 8 Participants |
| Nilotinib | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Serious Adverse Events | 9 Participants |
| Nilotinib | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs-Treatment-related | 3 Participants |
| Nilotinib | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Fatal SAEs | 1 Participants |
| Nilotinib | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Fatal SAEs-Treatment-related | 0 Participants |