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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01478373
• Date of registration: 16/11/2011
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Efficacy and Safety of Dovitinib in Patients With Gastrointestinal Stromal Tumors Refractory and/or Intolerant to Imatinib
• Scientific title: 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
• Date of first enrolment: January 2012
• Target sample size: 39
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01478373
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Belgium, Finland, France, Germany, Italy, Spain

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

• Name: Study Director
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion 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

Other protocol-defined inclusion/exclusion criteria may apply.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Gastrointestinal Stromal Tumors

Intervention(s)

Drug: Dovitinib (TKI258)

Primary Outcome(s)

Antitumor Activity of Dovitinib in Terms of Disease Control Rate (DCR): Complete Response+Partial Response +Stable Disease [Time Frame: 12 Weeks]

Secondary Outcome(s)

Duration of Response or Stable Disease (SD) [Time Frame: 9 months]

Progression-free Survival (PFS) of Patients Treated With Dovitinib [Time Frame: 9 months]

Time to Tumor Progression (TTP)of Patients Treated With Dovitinib [Time Frame: 9 months]

DCR (CR+PR+SD) at the End of Treatment [Time Frame: Up to 9 months of estimated treatment]

Time to Treatment Failure (TTF)of Patients Treated With Dovitinib [Time Frame: 9 months]

Overall Response Rate (ORR) of Patients Treated With Dovitinib [Time Frame: Baseline, 12 weeks]

Overall Survival (OS) of Patients Treated With Dovitinib [Time Frame: 21 months (9 months of estimated treatment plus 12 months of survival follow up)]

Secondary ID(s)

2011-001725-24

CTKI258AIC02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 10/08/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01478373