Overview

Efficacy and Safety of Dovitinib in Patients With Gastrointestinal Stromal Tumors Refractory and/or Intolerant to Imatinib

Status:
Completed
Trial end date:
2014-07-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the efficacy and safety of Dovitinib in patients with gastrointestinal stromal tumors refractory and/or intolerant to Imatinib
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
Imatinib Mesylate
Criteria
Inclusion Criteria:

- Histologically confirmed GIST of any anatomical location, which is 1) unresectable
and/ or metastatic with documented disease progression while on therapy with imatinib
or 2) surgically removed localized GIST, recurrent on adjuvant imatinib or recurrent
within the first 3 months after discontinuation of adjuvant imatinib or 3) patients
with unresectable and/or metastatic GIST intolerant to imatinib

- Positive immunohistochemical staining for c-KIT (CD117); or negative staining for KIT,
but with either positive staining for DOG1 or an identified mutation of KIT or PDGFRA
gene

- Documented disease progression according to RECIST (version 1.1) on prior therapy with
imatinib at a dose of at least 400mg/day or patients with unresectable and/or
metastatic GIST who are intolerant to imatinib

- At least one measurable GIST lesion according to RECIST (version 1.1).

- Adequate bone marrow, liver and renal function

Exclusion Criteria:

- Patients who have received any other tyrosine-kinase inhibitor but imatinib for GIST

- Patients who received cytotoxic drugs ≤ 4 weeks prior to starting Dovitinib (TKI258)

- Patients who are treated or planned to be treated concomitantly with other cytotoxic
or antineoplastic treatments, such as chemotherapy, immunotherapy, biological response
modifiers, or radiotherapy

- Patients with another primary malignancy within 3 years prior to starting the study
drug

- Patients who have undergone major surgery (e.g. intra-thoracic, intra-abdominal or
intra-pelvic) ≤ 4 weeks prior to starting Dovitinib (TKI258) or who have not recovered
from the adverse effects of such therapy

- Patients with a history of pulmonary embolism (PE), or untreated deep venous
thrombosis (DVT) within the past 6 months

- Patients with impaired cardiac function or clinically significant cardiac diseases

- Patients with impairment of gastrointestinal (GI) function or GI disease that may
significantly alter the absorption of Dovitinib

- Patients with prior complete gastrectomy

- Patients with brain metastasis or history of brain metastasis

- Patients who are currently receiving anticoagulation treatment with therapeutic doses
of warfarin or equivalent anticoagulant

- Pregnant or breast-feeding women

Other protocol-defined inclusion/exclusion criteria may apply.