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

NCT ID: NCT01478373

Last Updated: 2016-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-07-31

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

Conditions

Gastrointestinal Stromal Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dovitinib (TKI258)

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.

Group Type: EXPERIMENTAL

Dovitinib (TKI258)

Intervention Type: DRUG

Oral Dovitinib (TKI258) as a gelatin capsule of 100 mg strength and dosed on a flat scale of 500 mg on a 5 days on /2 days off dosing schedule.

Interventions

Dovitinib (TKI258)

Oral Dovitinib (TKI258) as a gelatin capsule of 100 mg strength and dosed on a flat scale of 500 mg on a 5 days on /2 days off dosing schedule.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Study Director

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

HUS, , Finland

Novartis Investigative Site

Bordeaux, , France

Novartis Investigative Site

Lille, , France

Novartis Investigative Site

Lyon, , France

Novartis Investigative Site

Reims, , France

Novartis Investigative Site

Villejuif, , France

Novartis Investigative Site

Essen, , Germany

Novartis Investigative Site

Milan, MI, Italy

Novartis Investigative Site

Roma, RM, Italy

Novartis Investigative Site

Candiolo, TO, Italy

Novartis Investigative Site

Torino, TO, Italy

Novartis Investigative Site

Palma de Mallorca, Balearic Islands, Spain

Novartis Investigative Site

Barcelona, Barcelona, Spain

Novartis Investigative Site

Barcelona, Catalonia, Spain

Novartis Investigative Site

L'Hospitalet de Llobregat, Catalonia, Spain

Countries

Finland; France; Germany; Italy; Spain

Other Identifiers

2011-001725-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CTKI258AIC02

Identifier Type: -

Identifier Source: org_study_id