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Dose Escalation Study of ARQ 197 in Combination With Sorafenib in Adult Patients With Advanced Solid Tumors

NCT00827177 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2014-01-24

No results posted yet for this study

Summary

This is an open-label, dose-escalation study of ARQ 197 administered orally in combination with sorafenib.

Conditions

Interventions

DRUG

Treatment with ARQ 197 in combination with sorafenib

Patients will be treated with ARQ 197 and sorafenib at Dose Level 1 (ARQ 197 360 mg twice daily (bid) and sorafenib 200 mg bid). Patients with HCC will start treatment with ARQ 197 at 240 mg bid and sorafenib 200 mg bid. Enrollment of subsequent patient cohort will depend on the safety and tolerability of the combination treatment in the initial cohort. If \< 33% patients treated at Dose Level 1 experience dose-limiting toxicity(ies) (DLT) by the end of first treatment cycle (4 weeks), then next cohort of 6 patients will be enrolled and treated at Dose Level 2 (ARQ 197 360 mg bid and sorafenib 400 mg bid). If ≥ 33% patients treated at Dose Level 1 experience DLT(s) by the end of first treatment cycle, the next cohort of 6 patients will be enrolled and treated at Dose Level 0 (ARQ 197 240 mg bid and sorafenib 200 mg bid).

Sponsors & Collaborators

  • ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2012-09-30
Completion
2013-05-31

Countries

  • United States
  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00827177 on ClinicalTrials.gov