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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ACT Biotech, Inc
ClinicalTrials.gov Identifier:
NCT00952497
First received: July 30, 2009
Last updated: February 7, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Gastric Cancer
Drug: Cisplatin, Capecitabine, Telatinib
Phase 2

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

Resource links provided by NLM:


Further study details as provided by ACT Biotech, Inc:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: June 2009
Study Completion Date: January 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cisplatin, Capecitabine, Telatinib 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00952497

Locations
United States, California
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, Georgia
Central Georgia Cancer Care, P.C.
Macon, Georgia, United States, 31201
United States, Pennsylvania
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
The West Clinic
Memphis, Tennessee, United States, 38120
United States, Texas
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Spain
Hospital Universitari Germans Trias i Pujol
Barcelona, Spain, 08916
Hospital Vall d' Hebron
Barcelona, Spain, 08035
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital Clinico San Carlos
Madrid, Spain, 28040
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Hospital Universitario Marques de Valdecilla
Santander, Spain, 39008
Sponsors and Collaborators
ACT Biotech, Inc
Investigators
Study Director: Scott Freeman, MD ACT Biotech, Inc
  More Information

No publications provided

Responsible Party: ACT Biotech, Inc
ClinicalTrials.gov Identifier: NCT00952497     History of Changes
Other Study ID Numbers: TEL0805
Study First Received: July 30, 2009
Last Updated: February 7, 2012
Health Authority: United States: Food and Drug Administration
Spain: Agencia Espanola de Medicamentos y Productos Sanitarios

Keywords provided by ACT Biotech, Inc:
Gastric Cancer
Gastro-Esophageal Cancer
GE-Junction
Advanced Gastric Cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Capecitabine
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014