Phase 2
Completed N=39
Efficacy and Safety of Dovitinib in Patients With Gastrointestinal Stromal Tumors Refractory and/or Intolerant to Imatinib
Source: ClinicalTrials.gov NCT01478373 ↗Enrolled (actual)
39
Serious AEs
41.0%
Results posted
Aug 2015
Primary outcomePrimary: Antitumor Activity of Dovitinib in Terms of Disease Control Rate (DCR): Complete Response+Partial Response +Stable Disease — 52.6 Percentage of Participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Antitumor Activity of Dovitinib in Terms of Disease Control Rate (DCR): Complete Response+Partial Response +Stable Disease |
52.6 | — |
| SECONDARY Progression-free Survival (PFS) of Patients Treated With Dovitinib |
141 | — |
| SECONDARY Time to Treatment Failure (TTF)of Patients Treated With Dovitinib |
122.0 | — |
| SECONDARY Duration of Response or Stable Disease (SD) |
193.2 | — |
| SECONDARY Time to Tumor Progression (TTP)of Patients Treated With Dovitinib |
141.0 | — |
| SECONDARY Overall Response Rate (ORR) of Patients Treated With Dovitinib |
2.6 | — |
| SECONDARY Overall Survival (OS) of Patients Treated With Dovitinib |
NA | — |
| SECONDARY DCR (CR+PR+SD) at the End of Treatment |
52.6 | — |
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
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01478373). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.