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

NCT ID: NCT00952497

Last Updated: 2012-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2012-01-31

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cisplatin, Capecitabine, Telatinib

Group Type: EXPERIMENTAL

Cisplatin, Capecitabine, Telatinib

Intervention Type: 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.

Interventions

Cisplatin, Capecitabine, Telatinib

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ACT Biotech, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott Freeman, MD

Role: STUDY_DIRECTOR

ACT Biotech, Inc

Locations

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

Countries

United States; Spain

Other Identifiers

TEL0805

Identifier Type: -

Identifier Source: org_study_id