A Study of Telatinib in Combination With Chemotherapy in Subjects With Advanced Gastric Cancer

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Universitari Germans Trias i Pujol, Barcelona, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cisplatin, Capecitabine, Telatinib

Drug

Subjects will receive: Chemotherapy (capecitabine and cisplatin) and telatinib Capecitabine will be administered (1000 mg/m2) twice daily for 14 days followed by a 7-day rest period. Cisplatin (80 mg/m2) will be given as a 1-3 hour infusion once every 3 weeks. Telatinib (3 tablets) will be administered orally, twice daily as a continuous administration. After a maximum of 6 cycles of cisplatin, subjects continue with capecitabine and telatinib or monotherapy with either study drug,depending on the toxicity experienced by the subject, until disease progression.

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.

Time frame: 18 months from start of enrollment to evaluation of primary endpoint

Sponsors and collaborators

Lead sponsor

ACT Biotech, Inc

Industry

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2012
First posted: Aug 6, 2009
Registry last updated: Feb 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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