Phase III, Open-Label Study of Nilotinib Versus Imatinib in GIST Patients (ENESTg1)

Phase III, Open-Label Study of Nilotinib Versus Imatinib in GIST Patients (ENESTg1)

Gastrointestinal Stromal Tumor

Completed

3

Start Date 03/01/2009

Age of Trial (yrs) 14.8

First-line

KIT/PDGFRA inhibitor

Block KIT

Specifically GIST and only GIST

AMN107G2301 ENESTg1

Novartis

Novartis Pharmaceuticals

+1-800-340-6843

Randomized

Oral

April 11, 2011
Novartis discontinues clinical trial of Tasigna® for investigational use in newly diagnosed patients with unresectable and/or metastatic GIST

* Independent data monitoring committee recommends stopping ENESTg1 trial as interim efficacy results show Tasigna is unlikely to show superiority.

This phase 3 trial tested whether nilotinib (also known as AMN107 and Tasigna) given as initial treatment for metastatic GIST is better than the current initial therapy, imatinib (Gleevec).
Patients entering the trial were randomized to receive either imatinib or nilotinib.

Both nilotinib and imatinib are made by the trial sponsor, Novartis.
Inclusion Criteria:

1. Histologically confirmed diagnosis of GIST which is unresectable and/or metastatic and either:
* no prior therapy with imatinib or any investigational therapies (e.g .sunitinib). Note: newly diagnosed patients may have received up to 14 days imatinib treatment for disease management while awaiting study start.
* recurrent GIST after stopping adjuvant treatment with imatinib and no subsequent treatment with any other investigational therapies (for example sunitinib).
2. At least one measurable site of disease on CT/MRI scan
3. Performance status ≤ 2 (capable of self-care but unable to carry out any work)
4. Normal organ, electrolyte and marrow function

Exclusion Criteria:

1. Prior treatment with nilotinib or any other drug in this class or other targeted therapy agents with the exception of adjuvant imatinib.
2. Disease progression during adjuvant therapy with imatinib
3. Prior or concommitant malignancy that is currently clinically significant or currently requires active intervention.
4. Impaired cardiac function

Other protocol-defined inclusion/exclusion criteria may apply