Trials / Completed
CompletedNCT01251796
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- Kyowa Kirin Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ARQ 197 and Erlotinib | Orally twice daily administration of ARQ197 and orally once daily administration of erlotinib hydrochloride |
Timeline
- Start date
- 2010-12-01
- Primary completion
- 2012-11-01
- Completion
- 2012-11-01
- First posted
- 2010-12-02
- Last updated
- 2017-03-15
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT01251796. Inclusion in this directory is not an endorsement.