A Study of Telatinib in Combination With Chemotherapy in Subjects With Advanced Gastric Cancer
This study has been completed.
Sponsor:
ACT Biotech, Inc
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
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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 May 21, 2013