Dovitinib for Patients With Tumor Pathway Activations Inhibited by Dovitinib (NCT01831726) | Clinical Trial Compass
CompletedPhase 2
Dovitinib for Patients With Tumor Pathway Activations Inhibited by Dovitinib
United States80 participantsStarted 2013-08
Plain-language summary
The purpose of this signal seeking study was to determine whether treatment with dovitinib (TKI258) demonstrated sufficient efficacy in select pathway-activated solid tumors and/or hematologic malignancies to warrant further study.
Who can participate
Age range18 Years – 100 Years
SexALL
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Inclusion criteria
✓. Patient's age was ≥ 18 years of age at the time of signing informed consent.
✓. Patient had a confirmed diagnosis of a selected solid tumor (except for primary diagnosis of urothelial tumors, hepatocellular carcinoma (HCC), endometrial carcinoma, metastatic breast cancer (mBC), squamous NSCLC, and renal cell carcinoma (RCC)) or hematologic malignancies (except for primary diagnosis of FLT3 AML and multiple myeloma). Additional tumor types could be excluded during the course of the study in the case of early futility or success based upon an interim analysis or at the discretion of Novartis.
✓. Patient was in need of treatment because of progression or relapse defined as:
✓. Patients had pre-identified tumor with a mutation and/or translocation of one of the known kinase targets of dovitinib. The qualifying alteration were assessed and reported by a CLIA-certified laboratory. The mutations included:
✓. FGFR 1-3 (amplifications were also allowed)
✓. PDGFRα or PDGFRβ
✓. VEGFR1-2 (KDR)
✓. FLT3, cKIT (amplifications are also allowed),
Exclusion criteria
✕. Patients who received prior treatment with dovitinib (TKI258).
✕. Patients with a known hypersensitivity to dovitinib (TKI258) or to its excipients.
✕. Patients with brain metastasis or history of brain metastasis or leptomeningeal carcinomatosis.
✕. Patients with a history of pulmonary embolism (PE), or untreated deep venous thrombosis (DVT) ≤ 6 months prior to starting study drug. Note: Patients with recent DVT who were treated with therapeutic anti-coagulant agents for at least 6 weeks are eligible.