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Completed

NCT Number: NCT01152645

Study of ARQ 197 Monotherapy

A phase II open-label study with ARQ 197 administered orally and twice daily as monotherapy in patients with previously treated advanced/recurrent gastric cancer. The primary endpoint is disease control and the secondary efficacy endpoints include antitumor effect (tumor response), progression-free survival and overall survival. The pharmacokinetic profile and the safety profile are also evaluated.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

20 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nagoya, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ARQ 197

Drug

Orally twice daily administration of ARQ 197

Primary outcomes

  1. Antitumor effect

    Time frame: Tumor size was measured at Baseline, Day 29 and 54, and then every 6 week until discontinuation criteria met.

    Disease control

Secondary outcomes

  1. Antitumor effect

    Time frame: Tumor size was measured at Baseline, Day 29 and 54, and then every 6 week until discontinuation criteria met.

    Tumor response

  2. Progression-free survival

    Time frame: Tumor size was measured at Baseline, Day 29 and 54, and then every 6 week until discontinuation criteria met. In addition, survival was confirmed by biweekly inquiry during the study, and by follow up survey.

  3. Overall survival

    Time frame: Survival was confirmed by biweekly inquiry during the study, and by follow up survey.

  4. Pharmacokinetic profile

    Time frame: Plasma sample correction at pre-dose, 1, 2, 4, 6, 10, 12 and 24 hours on Day 1, and in addition, at pre-dose of Day 15 and 29.

    Plasma ARQ 197 concentrations and pharmacokinetic parameters following the first dose of ARQ 197

  5. Adverse events

    Time frame: Patients will be monitored for occurrence of adverse events from the day of the first dosing to the completion of the examinations at the discontinuation of the study.

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study title

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

Acronym: ARQ 197-004

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 29, 2010
Registry last updated
Mar 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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