A Study of Telatinib in Combination With Chemotherapy in Subjects With Advanced Gastric Cancer
Completed · Phase 2
Conditions studied: Gastric Cancer
In brief
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.
Key facts
- Study ID
- NCT00952497
- Run by
- ACT Biotech, Inc
- People needed
- 48
- Starts
- 2009-06-01
- Expected to finish
- 2012-01-01
- Last updated by the study team
- 2012-02-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
- Central Georgia Cancer Care, P.C. — Macon, Georgia, United States
- University of Pennsylvania, Abramson Cancer Center — Philadelphia, Pennsylvania, United States
- The West Clinic — Memphis, Tennessee, United States
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
- Hospital Vall d' Hebron — Barcelona, Spain
- Hospital Universitari Germans Trias i Pujol — Barcelona, Spain
- Hospital Universitario Ramon y Cajal — Madrid, Spain
- Hospital Clinico San Carlos — Madrid, Spain
- Hospital Universitario 12 de Octubre — Madrid, Spain
- Hospital Universitario Marques de Valdecilla — Santander, Spain
Full record on ClinicalTrials.gov
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