Dovitinib for Patients With Tumor Pathway Activations Inhibited by Dovitinib
Condition: Tumor Pathway Activations Inhibited by Dovitinib
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      This was a phase II, open label study to determine the efficacy and safety of treatment with
      dovitinib (TKI258) in patients with a diagnosis of select solid tumors or hematological
      malignancies that have been pre-identified (prior to study consent) to have mutations,
      translocations or amplifications and whose disease has progressed on or after standard
      treatment.

      Genomic profiling is becoming more accessible to patients and their physicians. As such, more
      patients have been identified with potentially-actionable mutations, translocations or
      amplifications but do not have access to targeted drug treatment. This is a signal-seeking
      study to match patients with tumor pathway activations inhibited by dovitinib to the RTK
      inhibitor dovitinib. Pre-identification of mutations, translocations, or amplifications will
      be performed locally at a CLIA certified laboratory prior to participation on the trial.

      For the purpose of this study, genomic profiling is not considered part of screening.
      Informed consent must be signed before any screening activities take place. Once eligibility
      (screening criteria met) has been confirmed by Novartis, the patient will initiate therapy
      with dovitinib single-agent. The patient may not receive any additional anti-cancer therapy
      during treatment with dovitinib.

      Patients received study treatment until disease progression (assessed by investigator per
      RECIST 1.1 or appropriate hematologic response criteria), unacceptable toxicity, death or
      discontinuation from study treatment for any other reason (e.g., withdrawal of consent, start
      of a new anti-neoplastic therapy or at the discretion of the investigator), otherwise known
      as End of Treatment. All patients who discontinue from study treatment due to disease
      progression must have their progression clearly documented.

      Disease assessment (by RECIST 1.1 or appropriate hematological response criteria) will be
      performed every 8 weeks (±4 days) after first dose of study drug (Day 1 of every odd cycle),
      until disease progression or end of treatment, whichever occurs first. The frequency of
      disease assessment may be reduced to every 12 weeks for patients who have at least 4
      post-baseline disease assessments and are clinically stable (except AML patients). Scans was
      assessed locally by the investigator. After discontinuation of treatment, patients,
      regardless of reason for treatment discontinuation, will be followed for safety for 30 days
      after the last dose.

      All patients will be followed for survival status every 3 months for 2 years after the last
      patient has enrolled in the study,regardless of treatment discontinuation reason (except if
      consent is withdrawn or patient is lost to follow-up)
    

Intervention name(s): Dovitinib (TKI258)
Intervention type(s): Drug
Intervention description(s): Dovitinib (TKI) will be dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Solid tumor malignancy; hematologic malignancy; mutation; translocations; FGFR; PDGFR; VEGF; cKIT; FLT3; CSR1; Trk; RET; TKI258; dovitinib; signature; AML; acute myelogenous leukemia; GIST; gastrointestinal stromal tumor; Head and Neck cancer; Melanoma; NSCLC; non-small cell lung carcinoma; lung cancer; ovarian cancer; thyroid cancer; amplification