A Study of Telatinib in Combination With Chemotherapy in Subjects With Advanced Gastric Cancer
- Registration Number
- NCT00952497
- Lead Sponsor
- ACT Biotech, Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cisplatin, Capecitabine, Telatinib Cisplatin, Capecitabine, Telatinib -
- Primary Outcome Measures
Name Time Method 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. 6 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (11)
UCSF Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Central Georgia Cancer Care, P.C.
🇺🇸Macon, Georgia, United States
University of Pennsylvania, Abramson Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Hospital Vall d' Hebron
🇪🇸Barcelona, Spain
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Hospital Universitario Marques de Valdecilla
🇪🇸Santander, Spain
The West Clinic
🇺🇸Memphis, Tennessee, United States
Hospital Universitari Germans Trias i Pujol
🇪🇸Barcelona, Spain
Hospital Universitario Ramon y Cajal
🇪🇸Madrid, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain