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

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Cisplatin, Capecitabine, Telatinib
Sponsored by
ACT Biotech, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric Cancer, Gastro-Esophageal Cancer, GE-Junction, Advanced Gastric Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCSF Helen Diller Family Comprehensive Cancer Center
  • Central Georgia Cancer Care, P.C.
  • University of Pennsylvania, Abramson Cancer Center
  • The West Clinic
  • The University of Texas MD Anderson Cancer Center
  • Hospital Vall d' Hebron
  • Hospital Universitari Germans Trias i Pujol
  • Hospital Universitario Ramon y Cajal
  • Hospital Clinico San Carlos
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario Marques de Valdecilla

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cisplatin, Capecitabine, Telatinib

Arm Description

Outcomes

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.

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.

Full Information

First Posted
July 30, 2009
Last Updated
February 7, 2012
Sponsor
ACT Biotech, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00952497
Brief Title
A Study of Telatinib in Combination With Chemotherapy in Subjects With Advanced Gastric Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ACT Biotech, Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Gastric Cancer, Gastro-Esophageal Cancer, GE-Junction, Advanced Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cisplatin, Capecitabine, Telatinib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cisplatin, Capecitabine, Telatinib
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Freeman, MD
Organizational Affiliation
ACT Biotech, Inc
Official's Role
Study Director
Facility Information:
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Central Georgia Cancer Care, P.C.
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
University of Pennsylvania, Abramson Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
The West Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Hospital Vall d' Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain

12. IPD Sharing Statement

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

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