Clinical Trial of ARQ 761 in Advanced Solid Tumors
Summary
Primary Objective:
To determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 761 administered intravenously.
Secondary Objectives:
To determine the pharmacokinetic profile of ARQ 761
Description
This is an open label, dose escalation study of ARQ 761 administered intravenously at a starting dose of 195 mg/m2 IV once weekly. Depending on toxicities observed, up to seven treatment cohorts will be enrolled with dose escalation occurring by doubling (first escalation) and 40% increments thereafter. If dosing is tolerated at all levels and pharmacokinetic data suggest continued escalation is warranted, additional dose levels will be considered.
Pharmacokinetic assessments will be performed on days 1 and 15 of the first cycle. Safety and tolerability of ARQ 761 will be assessed for the duration of study treatment. Evaluation of potential anti-tumor activity of ARQ 761 will be performed at regular intervals while patients remain on study.
Patients receiving doses of ARQ 761 may be escalated a maximum of two times to the next consecutive cohorts.
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Solid Tumors
Intervention
ARQ 761
Location
UT Southwestern Medical Center - Simmons Cancer Center
Dallas
Texas
United States
75390
Status
Recruiting
Source
University of Texas Southwestern Medical Center
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01502800
- Information obtained from ClinicalTrials.gov on January 26, 2012
Medical and Biotech [MESH] Definitions
Lomustine
An alkylating agent of value against both hematologic malignancies and solid tumors.
Brenner Tumor
A smooth, solid or cystic fibroepithelial (FIBROEPITHELIAL NEOPLASMS) tumor, usually found in the OVARIES but can also be found in the adnexal region and the KIDNEYS. It consists of a fibrous stroma with nests of epithelial cells that sometimes resemble the transitional cells lining the urinary bladder. Brenner tumors generally are benign and asymptomatic. Malignant Brenner tumors have been reported.
Bleomycin
A complex of related glycopeptide antibiotics from Streptomyces verticillus consisting of bleomycin A2 and B2. It inhibits DNA metabolism and is used as an antineoplastic, especially for solid tumors.
Mitomycins
A group of methylazirinopyrroloindolediones obtained from certain Streptomyces strains. They are very toxic antibiotics used as ANTINEOPLASTIC AGENTS in some solid tumors. PORFIROMYCIN and MITOMYCIN are the most useful members of the group.
Chromomycins
A complex of several closely related glycosidic antibiotics from Streptomyces griseus. The major component, CHROMOMYCIN A3, is used as a fluorescent stain of DNA where it attaches and inhibits RNA synthesis. It is also used as an antineoplastic agent, especially for solid tumors.
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