A Study of ARQ 171 in Patients With Advanced Solid Tumors

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00398840
• Other study ID #: ARQ 171-101
• Status: Terminated
• Phase: Phase 1
• First received: November 9, 2006
• Last updated: March 2, 2017
• Start date: November 2006
• Est. completion date: September 2008

Study information

• Verified date: March 2017
• Source: ArQule
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• ARQ 171

Locations

Country	Name	City	State
United States	Dana Farber/Harvard Cancer Center	Boston	Massachusetts
United States	Mary Crowley Medical Research Center	Dallas	Texas
United States	Premiere Oncology	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
ArQule

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the safety, tolerability and maximum tolerated dose (MTD) of ARQ 171
Secondary	To determine the pharmacokinetic profile of ARQ 171
Secondary	To assess the preliminary anti-tumor activity of ARQ 171