Dose Escalation Study of ARQ 621 in Adult Patients With Metastatic Solid Tumors and Hematologic Malignancies
NCT00825487 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2011-10-19
Summary
This is an open-label, dose escalation study of intravenous ARQ 621 administered to patients with late-stage solid tumors or hematologic malignancies.
Conditions
- Metastatic Solid Tumors, Refractory/Relapsed Hematologic Malignancies
Interventions
- DRUG
-
ARQ 621
Treatment will be initiated at a dose level of 10 mg/m\^2 IV infusion for an hour once weekly in 4-week (28 day) consecutive and continuous cycles. ARQ 621 should be infused IV over two hours at doses 200 mg/m\^2 and higher (cohort 8 and above).
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
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-08-31
- Primary Completion
- 2011-05-31
- Completion
- 2011-09-30
Countries
- United States
Study Locations
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