NCT00825487

Dose Escalation Study of ARQ 621 in Adult Patients With Metastatic Solid Tumors and Hematologic Malignancies

A Phase 1 Dose Escalation Study of ARQ 621 in Adult Patients With Metastatic Solid Tumors and Hematologic Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, dose escalation study of intravenous ARQ 621 administered to patients with late-stage solid tumors or hematologic malignancies.

Detailed description

The study is designed to explore the safety, tolerability and pharmacokinetics of ARQ 621 and define a recommended phase 2 (RP2D)dose of 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). All cycles of therapy will consist of the patient taking ARQ 621 intravenously once weekly for 4 weeks. Dose escalation will proceed initially by doubling (cohorts 2 and 3) and subsequently by a modified Fibonacci scheme. Dose escalations will be performed using 3-6 patient cohorts. In these cohorts, if a single dose limiting toxicity (DLT) is experienced among patients 1-3, the dose cohort will be expanded to six patients. The maximum tolerated dose (MTD) will be defined as the dose level at which no greater than 1/6 patients experiences a DLT. Once an MTD is identified, up to an additional 20 patients (with types of malignancy to be determined at a later date by study investigator and clarified by study amendment) may be treated at this MTD of ARQ 621. If an MTD is not identified in the initial 10 dosing cohorts, dose escalation will proceed in a manner to be defined by subsequent amendment with the purpose of determining a RP2D of ARQ 621.

Conditions

• Metastatic Solid Tumors, Refractory/Relapsed Hematologic Malignancies

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2009-08-01
• Primary completion: 2011-05-01
• Completion: 2011-09-01
• First posted: 2009-01-21
• Last updated: 2011-10-19

Locations

4 sites across 1 country: United States