Dovitinib for Patients With Tumor Pathway Activations Inhibited by Dovitinib



Status:Completed
Healthy:No
Age Range:18 - 100
Updated:4/21/2016
Start Date:August 2013
End Date:December 2015

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Modular Phase II Study to Link Targeted Therapy to Patients With Pathway Activated Tumors: Module 2 - Dovitinib for Patients With Tumor Pathway Activations Inhibited by Dovitinib Including Tumors With Mutations or Translocations of FGFR, PDGFR, VEGF, cKIT, FLT3, CSFR1, Trk and RET

The purpose of this signal seeking study is to determine whether treatment with dovitinib
(TKI258) demonstrates sufficient efficacy in select pathway-activated solid tumors and/or
hematologic malignancies to warrant further study.

This is 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.

Once the patient has been identified, treating physicians who are qualified investigators
may contact Novartis to consider enrollment in this study. 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 will continue to receive 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
will be 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)

Inclusion Criteria:

- Patient has a confirmed diagnosis of a select solid tumor (except primary diagnosis
of urothelial tumors, hepatocellular carcinoma (HCC), endometrial carcinoma,
metastatic breast cancer (mBC), squamous non-small cell lung cancer (NSCLC), and
renal cell carcinoma (RCC)) or hematologic malignancies (except primary diagnosis of
FLT3 AML or multiple myeloma) and is in need of treatment because of progression or
relapse. Additional tumor types may 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's tumor has been evaluated and pre-identified with a relevant pathway
activation inhibited by dovitinib at a CLIA certified laboratory

- Patient must have received at least one prior treatment for recurrent, metastatic and
/or locally advanced disease and for whom no standard therapy options are anticipated
to result in a durable remission.

- Patient must have progressive and measurable disease as per RECIST 1.1. or other
appropriate hematological guidelines.

- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

Exclusion Criteria:

- Patient has received prior treatment with dovitinib (TKI258)

- Patients with brain metastasis or history of brain metastasis or leptomeningeal
carcinomatosis

- Patients with clinical evidence of active CNS leukemia

- Patient has received chemotherapy or targeted anticancer therapy ≤ 4 weeks (6 weeks
for nitrosourea, antibodies or mitomycin-C) prior to starting study drug.

- Patient is currently receiving prasugrel, clopidogrel, or full dose anticoagulation
treatment with therapeutic doses of warfarin. However, treatment with low doses of
warfarin (e.g., ≤2 mg/day) or locally accepted low doses of acetylsalicylic acid (up
to 100 mg daily) to prevent cardiovascular events or strokes is allowed.
We found this trial at
49
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100 N Humphreys Blvd
Memphis, Tennessee 38120
(901) 683-0055
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5150 Centre Ave
Pittsburgh, Pennsylvania 15232
(412) 647-2811
University of Pittsburgh Cancer Institute Founded in 1985, the University of Pittsburgh Cancer Institute (UPCI)...
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