Phase 3
N=125
Efficacy of Nilotinib in Adult Patients With Gastrointestinal Stromal Tumors Resistant to Imatinib and Sunitinib.
Gastrointestinal Stromal Tumors
Bottom Line
View on ClinicalTrials.gov: NCT01289028 ↗Enrolled (actual)
125
Serious AEs
48.0%
Results posted
Nov 2016
Primary outcome: Primary: Percent of Patients Achieving Stable Disease (SD) — 48.8 % participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Nilotinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Patients Achieving Stable Disease (SD) |
48.8 | — |
| PRIMARY Percent of Patients Achieving Partial Response (PR) |
— | — |
| PRIMARY Percent of Patients Achieving Complete Response (CR) |
— | — |
| SECONDARY Analysis of Time to Overall Response (CR or PR) According to RECIST Using Kaplan-Meier Method for ITT Population |
92.0; 92.0 | — |
| SECONDARY Time to Overall Response (CR or PR): Per Protocol Population |
91.2; 91.2 | — |
| SECONDARY Time to Tumor Progression |
— | — |
| SECONDARY Duration of Overall Response |
1331 | — |
| SECONDARY Overall Survival, Number of Events Related to Progression of the Disease |
17 | — |
| SECONDARY Progression Free Survival (PFS) of the Patients Who Were Included Due to an Intolerability of a Prior Treatment. |
110 | — |
Summary
This study will evaluate the preliminary efficacy of nilotinib in pretreated patients (Imatinib, Sunitinib) with unresectable or metastatic gastrointestinal stromal tumors.
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed diagnosis of GIST that is unresectable and/or metastatic and therefore not amenable to surgery or combined modality with curative intent.
- Radiologically confirmed disease progression during imatinib therapy at a dose of at least 400 mg daily and/or radiologically confirmed disease progression during sunitinib therapy OR documented intolerance to imatinib and/or sunitinib. (Patients with prior additional investigational treatment of GIST prior to study entry can be included.)
- At least one measurable site of disease on CT/MRI as defined by RECIST criteria.
Exclusion Criteria
- Prior treatment with nilotinib.
- Treatment with any cytotoxic and/or investigational cytotoxic drug ≤ 4 weeks (6 weeks for nitrosurea or mitomycin C) prior to Visit 1.
- Prior or concomitant malignancies requiring active treatment other than GIST with the exception of previous or concomitant basal cell skin cancer, previous cervical carcinoma in situ.
- Impaired cardiac function at visit 1
- Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol e.g. impairment of gastrointestinal (GI) function, or GI disease that may significantly alter the absorption of the study drugs, uncontrolled diabetes.
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01289028). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.