A Study of ARQ 171 in Patients With Advanced Solid Tumors

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

Status and phase

Terminated

Phase 1

Conditions

Cancer

Treatments

Drug: ARQ 171

Study type

Interventional

Funder types

Industry

Identifiers

ARQ 171-101

Details and patient eligibility

About

This is an open label, dose escalation study of ARQ 171 administered via intravenous infusion (IVI) into a peripheral vein weekly.

Patients with advanced solid tumors, who are refractory to available therapy or for whom no standard systemic therapy exists, will be enrolled.

Enrollment

14 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Signed written informed consent must be obtained and documented prior to study-specific screening procedures.
A histologically or cytologically confirmed advanced solid tumor
≥ 18 years of age
Measurable disease as defined by Response Evaluation Criteria in Solid Tumors
Karnofsky performance status ≥ 70%
Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after participation.
Females of childbearing potential must have a negative serum pregnancy test.
Laboratory results must meet study criteria.

Exclusion criteria

Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within four weeks of first infusion
Surgery within 4 weeks prior to first infusion
Known untreated brain metastases
Pregnant or breastfeeding
Uncontrolled intercurrent illness, or uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements
Other cancer within the last five years, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin