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

Novartis

Status and phase: Completed; Phase 2

Conditions: Gastrointestinal Stromal Tumors

Treatments: Drug: Dovitinib (TKI258)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01478373

2011-001725-24 (EudraCT Number)

CTKI258AIC02

Details and patient eligibility

About

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

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

Dovitinib (TKI258)

Experimental group

Description:

Patients will receive Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.

Treatment:

Drug: Dovitinib (TKI258)