A Phase 3 interventional study of Nilotinib (AMN107) and imatinib (STI571) in Gastrointestinal Stromal Tumor (GIST), sponsored by Novartis Pharmaceuticals. Completed at 165 sites in 35 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-16.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 3, Interventional, and Treatment
This study will evaluate efficacy and safety of nilotinib versus imatinib in adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST).
345 studies on the registry are indexed under Gastrointestinal Stromal Tumors; 60 are open to participants now.
This study's enrollment of 644 is above 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.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Histologically confirmed diagnosis of GIST which is unresectable and/or metastatic and either:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
nilotinib 400 mg twice a day
Drug: Nilotinib (AMN107)
imatinib 400 mg once daily
Drug: imatinib (STI571)
Also known as: Glivec/Gleevec
Time to Progression Free Survival (PFS)
PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time frame: up to month 37
| Milestone | Imatinib First, Then Nilotinib | Nilotinib First, Then Imatinib |
|---|---|---|
| Started | 324 | 320 |
| Completed | 0 | 0 |
| Not completed | 324 | 320 |
| Withdrew: Patients didn't receive 1st line therapy | 3 | 4 |
| Withdrew: Adverse event | 31 | 21 |
| Withdrew: Abnormal laboratory value | 1 | 0 |
| Withdrew: Abnormal test procedure result | 2 | 2 |
| Withdrew: Withdrawal by subject | 16 | 17 |
| Withdrew: Lost to follow-up | 3 | 7 |
| Withdrew: Administrative problems | 3 | 3 |
| Withdrew: Death | 5 | 8 |
| Withdrew: Disease progression | 139 | 119 |
| Withdrew: Protocol deviation | 5 | 6 |
| Withdrew: Study terminated by sponsor | 116 | 133 |
| Milestone | Imatinib First, Then Nilotinib | Nilotinib First, Then Imatinib |
|---|---|---|
| Started | 39 | 125 |
| Completed | 0 | 0 |
| Not completed | 39 | 125 |
| Withdrew: Adverse event | 4 | 5 |
| Withdrew: Withdrawal by subject | 6 | 6 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Administrative problems | 2 | 0 |
| Withdrew: Death | 1 | 5 |
| Withdrew: Disease progression | 22 | 70 |
| Withdrew: Protocol deviation | 0 | 2 |
| Withdrew: Study terminated by sponsor | 3 | 37 |
PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
| months | Nilotinib | Imatinib |
|---|---|---|
| Time to Progression Free Survival (PFS) | 25.9 (0 to 32.8) | 29.7 (0 to 36.1) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nilotinib | — | 80/321 (24.9%) | 291/321 (90.7%) |
| Imatinib | — | 85/316 (26.9%) | 289/316 (91.5%) |
| Crossover Nilotinib | — | 15/39 (38.5%) | 28/39 (71.8%) |
| Crossover Imatinib | — | 26/125 (20.8%) | 89/125 (71.2%) |
| Event | Nilotinib | Imatinib | Crossover Nilotinib | Crossover Imatinib |
|---|---|---|---|---|
| Abdominal painGastrointestinal disorders | 15/321 | 12/316 | 4/39 | 3/125 |
| AnaemiaBlood and lymphatic system disorders | 6/321 | 3/316 | 2/39 | 3/125 |
| PainGeneral disorders | 0/321 | 0/316 | 2/39 | 1/125 |
| DizzinessNervous system disorders | 0/321 | 0/316 | 2/39 | 0/125 |
| VomitingGastrointestinal disorders | 5/321 | 3/316 | 1/39 | 4/125 |
| Colonic fistulaGastrointestinal disorders | 0/321 | 0/316 | 1/39 | 0/125 |
| Gastrointestinal haemorrhageGastrointestinal disorders | 5/321 | 5/316 | 1/39 | 0/125 |
| Intestinal obstructionGastrointestinal disorders | 4/321 | 2/316 | 1/39 | 3/125 |
| Small intestinal haemorrhageGastrointestinal disorders | 0/321 | 0/316 | 1/39 | 0/125 |
| Disease progressionGeneral disorders | 0/321 | 0/316 | 1/39 | 1/125 |
| Event | Nilotinib | Imatinib | Crossover Nilotinib | Crossover Imatinib |
|---|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 46/321 | 106/316 | 2/39 | 17/125 |
| NauseaGastrointestinal disorders | 73/321 | 105/316 | 12/39 | 20/125 |
| RashSkin and subcutaneous tissue disorders | 89/321 | 46/316 | 4/39 | 12/125 |
| Oedema peripheralGeneral disorders | 29/321 | 68/316 | 2/39 | 17/125 |
| VomitingGastrointestinal disorders | 51/321 | 65/316 | 5/39 | 10/125 |
| FatigueGeneral disorders | 66/321 | 65/316 | 7/39 | 12/125 |
| Abdominal painGastrointestinal disorders | 63/321 | 61/316 | 6/39 | 18/125 |
| HyperbilirubinaemiaHepatobiliary disorders | 63/321 | 11/316 | 3/39 | 3/125 |
| AnaemiaBlood and lymphatic system disorders | 38/321 | 61/316 | 7/39 | 20/125 |
| Periorbital oedemaEye disorders | 2/321 | 58/316 | 0/39 | 9/125 |
| Age, Continuous(years) | Imatinib First, Then Nilotinib | Nilotinib First, Then Imatinib | Total |
|---|---|---|---|
| Mean | 57.4 ± 12.91 | 57.3 ± 12.63 | 57.35 ± 12.77 |
| Sex: Female, Male(Participants) | Imatinib First, Then Nilotinib | Nilotinib First, Then Imatinib | Total |
|---|---|---|---|
| Female | 145 | 133 | 278 |
| Male | 179 | 187 | 366 |
Showing the first 100 of 165 sites across 35 countries.
The record gives a start of Mar 2009, a primary completion of Oct 2014 and a completion of Oct 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Apr 2016, 1 year 6 months after primary completion.
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This study is completed, as verified in May 2016. 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 →