A Phase 2 interventional study of nilotinib in Gastrointestinal Stromal Tumors, sponsored by Novartis Pharmaceuticals. Completed at 11 sites in Japan. Open to participants aged 18 Years to 84 Years. Per ClinicalTrials.gov, last updated 2024-08-19.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 2, Interventional, and Treatment
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.
345 studies on the registry are indexed under Gastrointestinal Stromal Tumors; 60 are open to participants now.
This study's enrollment of 15 is below the median of 50 across 253 interventional studies indexed under Gastrointestinal Stromal Tumors.
Browse Gastrointestinal Stromal Tumors studies →Novartis Pharmaceuticals is the lead sponsor of 2,711 studies on the registry; 218 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 435 (75%) have results posted.
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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.
Drug: nilotinib
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.
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.
Participants took part in 11 investigative sites in Japan.
| Milestone | Nilotinib |
|---|---|
| Started | 15 |
| Completed | 2 |
| Not completed | 13 |
| Withdrew: Disease progression | 9 |
| Withdrew: Adverse event | 2 |
| Withdrew: Death | 1 |
| Withdrew: Withdrawal by subject | 1 |
Number of participants with adverse events (AEs) (any AE regardless of seriousness), serious adverse events (SAEs), Fatal SAEs and treatment related AEs.
| Participants | Nilotinib |
|---|---|
| Adverse Events | 13 |
| AEs-Treatment-related | 8 |
| Serious Adverse Events | 9 |
| SAEs-Treatment-related | 3 |
| Fatal SAEs | 1 |
| Fatal SAEs-Treatment-related | 0 |
Collected over Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nilotinib | 1/15 (6.7%) | 9/15 (60%) | 12/15 (80%) |
| Event | Nilotinib |
|---|---|
| Acute myocardial infarctionCardiac disorders | 2/15 |
| CataractEye disorders | 1/15 |
| IleusGastrointestinal disorders | 1/15 |
| Small intestinal haemorrhageGastrointestinal disorders | 1/15 |
| DehydrationMetabolism and nutrition disorders | 1/15 |
| Tumour haemorrhageNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/15 |
| Cerebellar infarctionNervous system disorders | 1/15 |
| Cerebrovascular insufficiencyNervous system disorders | 1/15 |
| Thrombotic cerebral infarctionNervous system disorders | 1/15 |
| Event | Nilotinib |
|---|---|
| NasopharyngitisInfections and infestations | 5/15 |
| Oedema peripheralGeneral disorders | 4/15 |
| InfluenzaInfections and infestations | 3/15 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 3/15 |
| AnaemiaBlood and lymphatic system disorders | 2/15 |
| Dental cariesGastrointestinal disorders | 2/15 |
| MalaiseGeneral disorders | 2/15 |
| HyperbilirubinaemiaHepatobiliary disorders | 2/15 |
| HypertensionVascular disorders | 2/15 |
| Angina pectorisCardiac disorders | 1/15 |
| Age, Continuous(years) | Nilotinib |
|---|---|
| Mean | 64.5 ± 13.39 |
| Sex: Female, Male(Participants) | Nilotinib |
|---|---|
| Female | 7 |
| Male | 8 |
| Race/Ethnicity, Customized(Participants) | Nilotinib |
|---|---|
| Japanese | 15 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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.
Ran from Jun 2013 to primary completion in Oct 2023, 123 months.
Results were first posted in Aug 2024, 10 months after primary completion.
Of 48 phase 2 interventional studies under Gastrointestinal Stromal Tumors, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 88. This study's 123 months is above that.
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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Nilotinib
Gastrointestinal Stromal Tumors →