A Phase 2 Open-Label Study Evaluating the Efficacy and Safety of Telatinib in Combination With Chemotherapy as First-Line Therapy in Subjects With Advanced Gastric Cancer

ACT Biotech, Inc11 sites in 2 countries48 target enrollmentJune 2009

ConditionsGastric Cancer

InterventionsCisplatin, Capecitabine, Telatinib

DrugsCisplatin, Capecitabine, Telatinib

Overview

Phase: Phase 2
Intervention: Cisplatin, Capecitabine, Telatinib
Conditions: Gastric Cancer
Sponsor: ACT Biotech, Inc
Enrollment: 48
Locations: 11
Primary Endpoint: The primary objective is to assess progression free survival (PFS). PFS will be measured from the date of first study drug administration to the date of first scan that first documents disease progression.
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The objectives of this study are to evaluate the anti-tumor activity, safety, and tolerability of telatinib when used in combination with chemotherapy (capecitabine and cisplatin) as first-line therapy in subjects with advanced gastric cancer. The primary objective is to assess progression free survival (PFS) in subjects receiving telatinib in combination with chemotherapy (capecitabine and cisplatin). The secondary objectives are to assess overall survival, overall response rate, safety and tolerability, pharmacokinetics and biomarkers.

Registry

clinicaltrials.gov

Start Date

June 2009

End Date

January 2012

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

ACT Biotech, Inc

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically or cytologically confirmed adenocarcinoma of the stomach or gastro-esophageal junction with inoperable locally advanced or metastatic disease, not amenable to curative therapy
•Measurable disease: At least 1 measurable metastatic lesion that has not been irradiated; The lesion will be measured according to RECIST and be evaluated radiologically within 28 days prior to study entry
•ECOG performance status of 0 or 1 at study entry
•Adequate bone marrow, liver and renal function
•Women of childbearing potential:Negative serum pregnancy test within 7 days and must agree to use adequate contraception (barrier method of birth control) prior to study entry, for the duration of study participation and 28 days after the last study drug dosing

Exclusion Criteria

•Previous chemotherapy for locally advanced or metastatic gastric cancer:prior neoadjuvant or adjuvant chemotherapy completed at least 6 months prior to study entry is allowed
•Previous anti-angiogenic therapy: Anti VEGF or VEGFR tyrosine kinase inhibitor such as bevacizumab, sorafenib, sunitinib, AZD2171
•Previous total platinum dose \>300 mg/m2: total prior platinum dose of ≤300 mg/m2 will be allowed in the adjuvant or neo-adjuvant setting
•Candidates for curative therapy
•Clinical or radiographic evidence of brain metastasis
•Cardiac disease; uncontrolled hypertension; hemorrhage/bleeding events
•Known or suspected allergy to any component of telatinib, cisplatin or capecitabine
•Known dihydropyrimidine dehydrogenase (DPD) deficiency
•Unable to take oral medications that could affect oral intake of capecitabine and telatinib

Arms & Interventions

Cisplatin, Capecitabine, Telatinib

Intervention: Cisplatin, Capecitabine, Telatinib

Outcomes

Primary Outcomes

The primary objective is to assess progression free survival (PFS). PFS will be measured from the date of first study drug administration to the date of first scan that first documents disease progression.

Time Frame: 6 months

Secondary Outcomes

Other efficacy variables are overall survival, overall response rate, safety and tolerability. Exploratory analyses may be performed to investigate the correlation of biomarker status with treatment effect and response.(18 months from start of enrollment to evaluation of primary endpoint)