Clinical trial · Interventional
Study of ARQ 197 Monotherapy
Phase II Study of ARQ 197 Monotherapy for Previously Treated Advanced/Recurrent Gastric Cancer
NCT01152645CI-TRIAL-00026468ARQ 197-004completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ARQ 197 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ARQ 197
- interventionNames
- Drug: ARQ 197
Primary outcomes (1)
- measure
- Antitumor effect
- timeFrame
- Tumor size was measured at Baseline, Day 29 and 54, and then every 6 week until discontinuation criteria met.
- description
- Disease control
Secondary outcomes (5)
- measure
- Antitumor effect
- timeFrame
- Tumor size was measured at Baseline, Day 29 and 54, and then every 6 week until discontinuation criteria met.
- description
- Tumor response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 74 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.