To evaluate the efficacy and safety of Dovitinib in patients with gastrointestinal stromal tumors refractory and/or intolerant to imatinib

• Conditions: nresectable, metastatic or recurrent gastrointestinal stromal tumor (GIST); MedDRA version: 14.1Level: LLTClassification code 10062427Term: Gastrointestinal stromal tumorSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-001725-24-IT
• Lead Sponsor: OVARTIS FARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-29
• Last Update Posted: 28 August 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

- Male or female patients = 18 years of age - 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 on KIT or PDGFRA genes; - 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). - A performance status of 0, 1 or 2 according to ECOG - Recovery from Grade 2 to 4 toxicity related to prior imatinib assessed according to NCI-CTCAE v.4.0 - Adequate bone marrow function - Adequate liver function - Adequate renal function Other protocol-defined inclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 11

Exclusion Criteria

- Patients who have received any other tyrosine-kinase inhibitor but imatinib for GIST;- Use of any investigational agent within 28 days prior to starting Dovitinib (TKI258) or foreseen use of an investigational agent during the study; - Imatinib must be discontinued at least 5 days before first dose of Dovitinib (TKI258);- 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;- Patients with another primary malignancy within 3 years prior to starting the study drug, with the exception of adequately treated in-situ carcinoma of the uterine cervix, or completely excised (R0 resection) basal or squamous cell carcinoma of the skin - Patients who have undergone major surgery 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 certain QT-related medicinal conditions;- Patients with impairment of gastrointestinal (GI) function or GI;disease that may significantly alter the absorption of Dovitinib;- Uncontrolled hypertension;- Patients with any clinically significant medical or surgical condition;which should preclude participation;- Known diagnosis of human immunodeficiency virus (HIV) infection.HIV testing is not mandatory;- Patients who are currently receiving anticoagulation treatment with therapeutic doses of warfarin or equivalent anticoagulant;- Pregnant or breast-feeding women;- Women of child-bearing potential not employing two highly effective methods of birth control having at least onefailure ratio < 1%;- Fertile males not willing to use contraception. Other protocol-defined exclusion criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified