- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00952497
A Study of Telatinib in Combination With Chemotherapy in Subjects With Advanced Gastric Cancer
February 7, 2012 updated by: ACT Biotech, Inc
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Barcelona, Spain, 08916
- Hospital Universitari Germans Trias i Pujol
-
Barcelona, Spain, 08035
- Hospital Vall d' Hebron
-
Madrid, Spain, 28034
- Hospital Universitario Ramón y Cajal
-
Madrid, Spain, 28040
- Hospital Clinico San Carlos
-
Madrid, Spain, 28041
- Hospital Universitario 12 de Octubre
-
Santander, Spain, 39008
- Hospital Universitario Marques De Valdecilla
-
-
-
-
California
-
San Francisco, California, United States, 94115
- UCSF Helen Diller Family Comprehensive Cancer Center
-
-
Georgia
-
Macon, Georgia, United States, 31201
- Central Georgia Cancer Care, P.C.
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania, Abramson Cancer Center
-
-
Tennessee
-
Memphis, Tennessee, United States, 38120
- The West Clinic
-
-
Texas
-
Houston, Texas, United States, 77030
- The University Of Texas MD Anderson Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
18 months from start of enrollment to evaluation of primary endpoint
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Scott Freeman, MD, ACT Biotech, Inc
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2009
Primary Completion (Actual)
October 1, 2011
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
July 30, 2009
First Submitted That Met QC Criteria
August 3, 2009
First Posted (Estimate)
August 6, 2009
Study Record Updates
Last Update Posted (Estimate)
February 8, 2012
Last Update Submitted That Met QC Criteria
February 7, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Stomach Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Cisplatin
- Capecitabine
Other Study ID Numbers
- TEL0805
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gastric Cancer
-
City of Hope Medical CenterRecruitingGastric Cancer | Gastric Adenocarcinoma | Gastric Cancer Stage IV | Gastric Neoplasm | Gastric Cancer Metastatic to Lung | Gastric Cancer Stage | Gastric Cancer Metastatic to Liver | Gastric Cancer Stage III | Gastric Cancer Stage II | Gastric Lesion | Gastric Cancer in Situ | Gastric Cancer Stage IIIB | Gastric... and other conditionsUnited States, Japan
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingGastric Adenocarcinoma | Clinical Stage III Gastric Cancer AJCC v8 | Clinical Stage 0 Gastric Cancer AJCC v8 | Clinical Stage I Gastric Cancer AJCC v8 | Clinical Stage II Gastric Cancer AJCC v8 | Clinical Stage IIA Gastric Cancer AJCC v8 | Clinical Stage IIB Gastric Cancer AJCC v8 | Pathologic Stage... and other conditionsUnited States
-
City of Hope Medical CenterActive, not recruitingAdenocarcinoma of the Gastroesophageal Junction | Stage IV Gastric Cancer | Recurrent Gastric Cancer | Diffuse Adenocarcinoma of the Stomach | Intestinal Adenocarcinoma of the Stomach | Mixed Adenocarcinoma of the Stomach | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric Cancer and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingGastric Adenocarcinoma | Clinical Stage III Gastric Cancer AJCC v8 | Clinical Stage I Gastric Cancer AJCC v8 | Clinical Stage IIA Gastric Cancer AJCC v8 | Clinical Stage IVA Gastric Cancer AJCC v8 | Pathologic Stage IB Gastric Cancer AJCC v8 | Pathologic Stage II Gastric Cancer AJCC v8 | Pathologic... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedGastric Adenocarcinoma | Stage IV Gastric Cancer | Stage II Gastric Cancer | Stage III Gastric CancerUnited States
-
Mayo ClinicNational Cancer Institute (NCI)CompletedGastroesophageal Junction Adenocarcinoma | Gastric Cardia Adenocarcinoma | Stage IB Gastric Cancer AJCC v7 | Stage II Gastric Cancer AJCC v7 | Stage IIA Gastric Cancer AJCC v7 | Stage IIB Gastric Cancer AJCC v7 | Stage IIIA Gastric Cancer AJCC v7 | Stage IIIB Gastric Cancer AJCC v7United States
-
National Cancer Institute (NCI)CompletedAdenocarcinoma of the Gastroesophageal Junction | Stage IV Gastric Cancer | Recurrent Gastric Cancer | Adenocarcinoma of the Stomach | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric CancerUnited States
-
National Cancer Institute (NCI)CompletedGastric Cancer | Gastric NeoplasmsUnited States
-
AIO-Studien-gGmbHBristol-Myers SquibbCompletedGastric Cancer | Esophageal Cancer | Adenocarcinoma Gastric | Metastatic Gastric Cancer | GastroEsophageal Cancer | HER2 Positive Gastric CancerGermany
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI)RecruitingGastric Adenocarcinoma | Epstein-Barr Virus Positive | Mismatch Repair Protein Deficiency | Stage IB Gastric Cancer AJCC v7 | Stage II Gastric Cancer AJCC v7 | Stage IIA Gastric Cancer AJCC v7 | Stage IIB Gastric Cancer AJCC v7 | Stage III Gastric Cancer AJCC v7 | Stage IIIA Gastric Cancer AJCC v7 | Stage... and other conditionsUnited States
Clinical Trials on Cisplatin, Capecitabine, Telatinib
-
Taizhou EOC Pharma Co., Ltd.Shanghai Zhongshan Hospital; Shanghai East HospitalUnknown
-
Samsung Medical CenterCompletedAdvanced or Recurrent Esophageal Squamous Cell CarcinomaKorea, Republic of
-
Asan Medical CenterBayerCompletedEffects of Chemotherapy | Malignant Neoplasm of StomachKorea, Republic of
-
Epidemiological and Clinical Research Information...Unknown
-
The University of Hong Kong-Shenzhen HospitalCompleted
-
Samsung Medical CenterCompletedPhase III Randomized Trial of Adjuvant XP Chemotherapy and XP/RT for Resected Gastric AdenocarcinomaGastric Cancer | SurgeryKorea, Republic of
-
Eisai Inc.Quintiles, Inc.TerminatedAdvanced or Metastatic Solid Tumors | Previously Untreated Gastric CancerUnited States, Russian Federation, United Kingdom, Ukraine
-
NYU Langone HealthNational Cancer Institute (NCI)Completed
-
Taizhou EOC Pharma Co., Ltd.Fountain Medical Development Co., Ltd.CompletedSolid Tumor, AdultChina
-
Dutch Colorectal Cancer GroupRoche Pharma AG; The Netherlands Cancer InstituteActive, not recruiting