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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00952497
Recruitment Status : Completed
First Posted : August 6, 2009
Last Update Posted : February 8, 2012
Information provided by (Responsible Party):
ACT Biotech, Inc

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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Cisplatin, Capecitabine, Telatinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2009
Actual Primary Completion Date : October 2011
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00952497

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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
Hospital Vall d' Hebron
Barcelona, Spain, 08035
Hospital Universitari Germans Trias i Pujol
Barcelona, Spain, 08916
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Hospital Clinico San Carlos
Madrid, Spain, 28040
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital Universitario Marques de Valdecilla
Santander, Spain, 39008
Sponsors and Collaborators
ACT Biotech, Inc
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Study Director: Scott Freeman, MD ACT Biotech, Inc
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Responsible Party: ACT Biotech, Inc Identifier: NCT00952497    
Other Study ID Numbers: TEL0805
First Posted: August 6, 2009    Key Record Dates
Last Update Posted: February 8, 2012
Last Verified: February 2012
Keywords provided by ACT Biotech, Inc:
Gastric Cancer
Gastro-Esophageal Cancer
Advanced Gastric Cancer
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action