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

Gastric Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00952497
• Other study ID #: TEL0805
• Status: Completed
• Phase: Phase 2
• First received: July 30, 2009
• Last updated: February 7, 2012
• Start date: June 2009
• Est. completion date: January 2012

Study information

• Verified date: February 2012
• Source: ACT Biotech, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSpain: Agencia Espanola de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Spain	Hospital Universitari Germans Trias i Pujol	Barcelona
Spain	Hospital Vall d' Hebron	Barcelona
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Ramon y Cajal	Madrid
Spain	Hospital Universitario Marques de Valdecilla	Santander
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Central Georgia Cancer Care, P.C.	Macon	Georgia
United States	The West Clinic	Memphis	Tennessee
United States	University of Pennsylvania, Abramson Cancer Center	Philadelphia	Pennsylvania
United States	UCSF Helen Diller Family Comprehensive Cancer Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
ACT Biotech, Inc

Countries where clinical trial is conducted

United States,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No