Clinical trial · Interventional
A Study of ARQ 197 in Combination With Erlotinib
A Phase I Study of ARQ 197 in Combination With Erlotinib in CYP2C19 Poor Metabolizer Patients With Advanced/Recurrent Non-Small-Cell Lung Cancer
- 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 I study to determine the safety, tolerability and recommended phase II dose of ARQ 197 given in combination with erlotinib as primary endpoints in CYP2C19 poor metabolizer patients with advanced/recurrent non-small-cell lung cancer. The pharmacokinetic profile and antitumor activity of ARQ 197 administered alone or in combination with erlotinib will also be determined as secondary endpoints.
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/Recurrent Non-small-cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ARQ 197 and Erlotinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ARQ 197 and Erlotinib
- description
- ARQ 197 and erlotinib hydrochloride
- interventionNames
- Drug: ARQ 197 and Erlotinib
Primary outcomes (1)
- measure
- Dose-Limiting Toxicity in the combination of tivantinib and erlotinib
- timeFrame
- DLT observation period started from the day of first single agent treatment to the day after the continuous combination treatment for 29 days.
- description
- Tivantinib was treated once as a single agent on Day 1. After 2 days of interruption, dayly treatments of the combination started.
Secondary outcomes (3)
- measure
- Pharmacokinetic profile of ARQ 197
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Voluntary written informed consent for study participation must be obtained * A histologically or cytologically confirmed advanced/recurrent non-small-cell lung cancer * History of ≥1 prior chemotherapy regimen (treatment with EGFR tyrosine kinase inhibitors will be counted as one regimen) * ECOG PS of 0 or 1 * Life expectancy of ≥3 months * Poor metabolizers as defined by CYP2C19 genotype Exclusion Criteria: * Anti-cancer chemotherapy, anti-cancer therapy with EGFR-TKI, hormone therapy, radiotherapy, immunotherapy, other investigational agents or anti-cancer antibody therapy within 28 days prior to ARQ 197 dose * Surgery for cancer within 28 days prior to ARQ 197 dose * Active double cancer * Known symptomatic brain metastases * An intercurrent illness that is uncontrolled (e.g., infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic arrhythmia, interstitial pneumonia) * Pregnant or lactating * Subjects who wish to have a child and who would not agree to use contraceptive measures
References
Publications (0)
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