Clinical trial · Interventional
A Phase 1 Study of ARQ 197 in Patients With Solid Tumors
A Phase 1 Dose Escalation Study of ARQ 197 in Adult Patients With Advanced/Recurrent Solid Tumors
NCT00609921CI-TRIAL-00007983completedPhase 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)
This is a Phase 1, open label, dose escalation study of ARQ 197 in patients with advanced/recurrent solid tumors. The purpose of this study is to determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 197.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ARQ197 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- ARQ197
- interventionNames
- Drug: ARQ197
Primary outcomes (1)
- measure
- Determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 197
Secondary outcomes (1)
- measure
- Assess the preliminary anti-tumor activity and determine the pharmacokinetic profile
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who did not respond or are refractory to available therapy or for whom no standard effective systemic therapy exists. * Karnofsky performance status (KPS) ≥ 70%, or Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 * Patients with adequate organ function Exclusion Criteria: * Anti-cancer chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or investigational agents within 4 weeks prior to the first dose of ARQ 197 * Known symptomatic brain metastases * Pregnant or breastfeeding * Uncontrolled intercurrent illness
References
Publications (0)
Data not yet available
No reference posted for this study.