Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Not Enrolling
Both
Gastric Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Scott Freeman, MD

Investigator Role:

Study Director

Investigator Affiliation:

ACT Biotech, Inc

Authority:

United States: Food and Drug Administration

Study ID:

TEL0805

NCT ID:

NCT00952497

Start Date:

June 2009

Completion Date:

January 2012

Related Keywords:

  • Gastric Cancer
  • Gastric Cancer
  • Gastro-Esophageal Cancer
  • GE-Junction
  • Advanced Gastric Cancer
  • Stomach Neoplasms

Name

Location

UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
The West ClinicMemphis, Tennessee  38120
Central Georgia Cancer Care, P.C.Macon, Georgia  31201
The University of Texas MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Pennsylvania, Abramson Cancer CenterPhiladelphia, Pennsylvania  19104