A Phase 1 Study of KBP-5209 in Patients With Advanced Solid Tumors



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/2/2016
Start Date:April 2015
End Date:December 2016
Contact:Matthew S Hunt, BA
Email:Matthew.hunt2@covance.com
Phone:608 332 8641

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The purpose of this study is to determine the maximum tolerated dose of KBP-5209 as a single
agent when given orally to adult patients with advanced solid tumors that have progressed
despite standard therapy, or where there is no standard therapy.

This is a Phase 1, open-label, multicenter study of KBP-5209 administered orally once daily
(QD) in 28-day treatment cycles to adult patients with advanced solid tumors which have
progressed despite standard therapy or for which no standard therapy exists. This study is
designed to determine the MTD or RP2D and to characterize the safety, tolerability, and PK
profile of KBP-5209.

Inclusion Criteria:

- Age 18 years or older;

- Patients with histologically or cytologically confirmed, advanced solid tumors which
have progressed despite standard therapy or for whom no standard therapy exists.

- Patients must have at least one measurable or non-measurable lesion (dose escalation
only) as defined by RECIST v1.1

- Eastern Cooperative Oncology Group performance score 0 to 2;

Exclusion Criteria:

- Patients with symptomatic CNS metastases;

- Patients who have a known history of hepatitis C or chronic active hepatitis B or a
known diagnosis of HIV

- Any significant ophthalmologic abnormality

- Patients who have any severe and/or uncontrolled medical conditions

- Significant gastrointestinal abnormalities,

- Patients who have impaired cardiac function or clinically significant cardiac
diseases,

- Chemotherapy, biologic therapy, immunotherapy, radiotherapy or investigational agents
within 5 half-lives or within 4 weeks (whichever is longer) prior to administration
of the first dose of study drug on Day 1 or have not recovered from the side effects
of such therapy;

- Treatment with third generation EGFR inhibitors

- Major surgery/surgical therapy for any cause within 4 weeks of Screening;
We found this trial at
3
sites
535 Barnhill Dr
Indianapolis, Indiana 46202
(888) 600-4822
Indiana University Melvin and Bren Simon Cancer Center At the IU Simon Cancer Center, more...
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Indianapolis, IN
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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Salt Lake City, UT
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