Phase 3
N=644
A Study of Nilotinib Versus Imatinib in GIST Patients
Gastrointestinal Stromal Tumor (GIST)
Bottom Line
View on ClinicalTrials.gov: NCT00785785 ↗Enrolled (actual)
644
Serious AEs
25.7%
Results posted
Apr 2016
Primary outcome: Primary: Time to Progression Free Survival (PFS) — 25.9; 29.7 months — p=0.0081
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Nilotinib (AMN107) (Drug); imatinib (STI571) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Progression Free Survival (PFS) |
25.9; 29.7 | 0.0081 sig |
Summary
This study will evaluate efficacy and safety of nilotinib versus imatinib in adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST).
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed diagnosis of GIST which is unresectable and/or metastatic and either:
- have not received any prior anti-neoplastic therapy other than adjuvant imatinib. Note: newly diagnosed patients may have received up to 14 days of treatment with imatinib for disease management while awaiting entry to the study or
- recurrent GIST after stopping adjuvant treatment with imatinib and no subsequent treatment with any other therapies.
- At least one measurable site of disease on CT/MRI scan
- Performance status ≤ 2 (capable of self-care but unable to carry out any work)
- Normal organ, electrolyte and marrow function
Exclusion Criteria
- Any prior anti-neoplastic therapy with the exception of patients who have received adjuvant imatinib or patients with newly diagnosed metastatic/ unresectable GIST whose disease requires therapy while awaiting entry to the study.
- Disease progression during adjuvant therapy with imatinib
- History of active malignancy (other than GIST) within 10 years prior to study entry with the exception of previous or concomitant basal cell skin cancer, previous cervical carcinoma in situ.
- Impaired cardiac function
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT00785785). 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.