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

Advanced Solid Tumors Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02442414
• Other study ID #: 5209-CPK-1001
• Status: Completed
• Phase: Phase 1
• Start date: April 7, 2015
• Est. completion date: November 26, 2019

Study information

• Verified date: February 2022
• Source: Sihuan Pharmaceutical Holdings Group Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 26, 2019
• Est. primary completion date: November 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

Drug:
• KBP-5209
Single oral dose beginning at 20 mg with daily dosing for 28 day cycles.

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Indiana University Melvin and Bren Simon Cancer Center	Indianapolis	Indiana
United States	University of Utah Huntsman Cancer Institute	Salt Lake City	Utah

Sponsors (3)

Lead Sponsor	Collaborator
Sihuan Pharmaceutical Holdings Group Ltd.	Covance, XuanZhu Pharma Co., Ltd.

Country where clinical trial is conducted

United States, 

References & Publications (5)

Gibaldi M, Perrier D. Pharmacokinetics. 2nd edition. New York, NY: Marcel Dekker, Inc.; 1982.

ICH E3: Guideline for Industry: Structure and Content of Clinical Study Reports. 1996.

Jaiswal BS, Kljavin NM, Stawiski EW, Chan E, Parikh C, Durinck S, Chaudhuri S, Pujara K, Guillory J, Edgar KA, Janakiraman V, Scholz RP, Bowman KK, Lorenzo M, Li H, Wu J, Yuan W, Peters BA, Kan Z, Stinson J, Mak M, Modrusan Z, Eigenbrot C, Firestein R, Stern HM, Rajalingam K, Schaefer G, Merchant MA, Sliwkowski MX, de Sauvage FJ, Seshagiri S. Oncogenic ERBB3 mutations in human cancers. Cancer Cell. 2013 May 13;23(5):603-17. doi: 10.1016/j.ccr.2013.04.012. Erratum in: Cancer Cell. 2014 Apr 14;25(4):543-4. — View Citation

Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-55. — View Citation

Simon R, Freidlin B, Rubinstein L, Arbuck SG, Collins J, Christian MC. Accelerated titration designs for phase I clinical trials in oncology. J Natl Cancer Inst. 1997 Aug 6;89(15):1138-47. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Outcome Measure: safety and tolerability, based on the rate of dose-limiting toxicities, toxicity grade, and reversibility of toxicity.		2 Years
Secondary	Dose-dependency of toxicity based on: dose limiting toxicities; frequency, type, grade, and seriousness, and causality of treatment-emergent adverse events, and laboratory assessments.		While undergoing study treatment and up to 30 days after the last dose of KBP-5209