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.