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

ACT Biotech

Status and phase: Completed; Phase 2

Conditions: Gastric Cancer

Treatments: Drug: Cisplatin, Capecitabine, Telatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00952497

TEL0805

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Cisplatin, Capecitabine, Telatinib

Experimental group

Treatment:

Drug: Cisplatin, Capecitabine, Telatinib