Clinical trial · Interventional
Study of ARQ 197 in Hepatocellular Carcinoma (HCC)
Phase I Study of ARQ 197 in Advanced Hepatocellular Carcinoma
NCT01656265CI-TRIAL-00026235completedPhase 1ClinicalTrials.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)
The purpose of this study is to evaluate the safety and tolerability of ARQ 197 in hepatocellular carcinoma (HCC) patients treated with daily oral ARQ 197, to determine the recommended dose of ARQ 197 in advanced HCC patients.
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 |
|---|---|---|---|
| Advanced Hepatocellular Carcinoma | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
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
- Number of participants with dose-limiting toxicity (DLT), as a measure of safety and tolerability
- timeFrame
- DLT observation period will be the first 28 days after the start of ARQ 197 treatment.
- description
- Adverse Event collection and assessment will be done for all treated subjects to assess the safety, tolerability. The grading for the severity of the adverse events will be determined according to CTCAE ver 4.0.
Secondary outcomes (2)
- measure
- Profiles of Pharmacokinetics
- timeFrame
- Plasma sample correction at pre-dose 1, 2, 4, 6, 10, 12 and 24 hours on day 1; at pre-dose, 1, 2, 4, 6, 10, 12 hours on day 15; and at pre-dose on day 29.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed HCC patients who are resistant to, intolerable to, or rejecting a systemic sorafenib therapy * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Child-Pugh classification A at the time of registration * Adequate bone marrow, liver, and renal functions within 14 days prior to registration Exclusion Criteria: * Prior therapy with a c-Met inhibitor (including ARQ 197) * Any systemic anti-tumor treatment or investigational agent within 2 weeks prior to registration. If the treatment/agent was antibody, within 4 weeks * Local treatment for malignancy within 4 weeks prior to registration * Major surgical procedure within 4 weeks prior to registration
References
Publications (0)
Data not yet available
No reference posted for this study.