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Phase II Study of ARQ 197 Monotherapy for Previously Treated Advanced/Recurrent Gastric Cancer


Phase 2
20 Years
74 Years
Not Enrolling
Both
Gastric Cancer

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Trial Information

Phase II Study of ARQ 197 Monotherapy for Previously Treated Advanced/Recurrent Gastric Cancer


Inclusion Criteria:



- Japanese or Korean with voluntary written informed consent for study participation

- A histologically or cytologically confirmed advanced/recurrent gastric cancer

- One or two prior chemotherapy regimens for advanced/recurrent gastric cancer

- At least one measurable lesion

- ECOG performance status of 0 or 1

- Life expectancy ≥3 months

Exclusion Criteria:

- Surgery for cancer within 4 weeks prior to the first dose of ARQ 197

- Confirmed other tumors than gastric cancer within 5 years prior to the first dose of
ARQ 197

- Anticancer chemotherapy, hormone therapy, radiotherapy or immunotherapy within 2
weeks prior to the first dose of ARQ 197

- Positive for HIV antibody

- Known symptomatic brain metastasis

- Gastrointestinal disorders that could interfere with the absorption of ARQ 197 or
operation history for gastrointestinal disorders

- Uncontrolled concomitant disease

- Patients who wish to have a child and who would not agree to use contraceptive
measures

- Pregnant or lactating

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Antitumor effect

Outcome Description:

Disease control

Safety Issue:

No

Authority:

Korea: Food and Drug Administration

Study ID:

ARQ 197-004

NCT ID:

NCT01152645

Start Date:

June 2010

Completion Date:

Related Keywords:

  • Gastric Cancer
  • Advanced/recurrent gastric cancer
  • Stomach Neoplasms

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