A Study of ARQ 171 in Patients With Advanced Solid Tumors

A Phase 1 Dose Escalation Study of ARQ 171 in Adult Patients With Advanced Solid Tumors

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00398840

Enrollment

Registered

2006-11-14

Start date

2006-11-30

Completion date

2008-09-30

Last updated

2017-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Cancer, Solid Tumors, advanced solid tumors

Brief summary

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.

Interventions

DRUGARQ 171

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
To determine the safety, tolerability and maximum tolerated dose (MTD) of ARQ 171	—

Secondary

Measure	Time frame
To determine the pharmacokinetic profile of ARQ 171	—
To assess the preliminary anti-tumor activity of ARQ 171	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026