Clinical trial NCT02442414: A Phase 1 Study of KBP-5209 in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: Cancer
Advanced Solid Tumors
EGFR
HER2
HER3
HER4
ALK mutations
irreversible tyrosine kinase inhibitor
Metastatic Non Small Cell Lung Cancer
Gastric Cancer
Colorectal Cancer
Lead sponsor: Sihuan Pharmaceutical Holdings Group Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Covance
name: XuanZhu Pharma Co., Ltd.
First posted: 2015-05-13
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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;

Primary outcomes:
measure: Outcome Measure: safety and tolerability, based on the rate of dose-limiting toxicities, toxicity grade, and reversibility of toxicity.
timeFrame: 2 Years
Secondary outcomes:
measure: Dose-dependency of toxicity based on: dose limiting toxicities; frequency, type, grade, and seriousness, and causality of treatment-emergent adverse events, and laboratory assessments.
timeFrame: While undergoing study treatment and up to 30 days after the last dose of KBP-5209
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Cancer Center
state: Indiana
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Huntsman Cancer Institute
state: Utah
Study officials:
References:
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