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DOVIGIST: Phase II Trial to Evaluate the Efficacy and Safety of Dovitinib (TKI258) in Patients With Gastrointestinal Stromal Tumors Refractory and/or Intolerant to Imatinib

Phase 4
18 Years
Open (Enrolling)
Gastrointestinal Stromal Tumors

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Trial Information

DOVIGIST: Phase II Trial to Evaluate the Efficacy and Safety of Dovitinib (TKI258) in Patients With Gastrointestinal Stromal Tumors Refractory and/or Intolerant to Imatinib

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

- Documented disease progression according to RECIST (version 1.1) on prior therapy
with imatinib 800mg/day or patients with unresectable and/or metastatic GIST who are
intolerant to 800 mg/day or less of 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Antitumor activity of Dovitinib in terms of disease control rate (DCR): CR+PR+SD

Outcome Description:

DCR is defined as the proportion of patients with a best overall response of Complete Responses (CR), Partial Response (PR) and Stable Disease (SD) at 12 weeks according to RECIST (version 1.1).

Outcome Time Frame:

12 Weeks

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

January 2012

Completion Date:

December 2013

Related Keywords:

  • Gastrointestinal Stromal Tumors
  • GIST
  • Dovitinib
  • Gastrointestinal Stromal Tumors