Status:
COMPLETED
Efficacy and Safety of Dovitinib in Patients With Gastrointestinal Stromal Tumors Refractory and/or Intolerant to Imatinib
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Gastrointestinal Stromal Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT01478373
Start Date
January 1 2012
End Date
July 1 2014
Last Update
April 27 2016
Active Locations (15)
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1
Novartis Investigative Site
HUS, Finland, FIN-00029
2
Novartis Investigative Site
Bordeaux, France, 33076
3
Novartis Investigative Site
Lille, France, 59020
4
Novartis Investigative Site
Lyon, France, 69373