A Study of ARQ 171 in Patients With Advanced Solid Tumors

This study has suspended participant recruitment.

Sponsor:

Information provided by:

ArQule

ClinicalTrials.gov Identifier:

NCT00398840

First received: November 9, 2006

Last updated: January 8, 2009

Last verified: January 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	November 9, 2006
Last Updated Date	January 8, 2009
Start Date ^ICMJE	November 2006
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: April 9, 2007)	To determine the safety, tolerability and maximum tolerated dose (MTD) of ARQ 171
Original Primary Outcome Measures ^ICMJE (submitted: November 9, 2006)	To determine the safety, tolerability and maximum tolerated dose (MTD) of ARQ 171.
Change History	Complete list of historical versions of study NCT00398840 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 9, 2007)	To determine the pharmacokinetic profile of ARQ 171 To assess the preliminary anti-tumor activity of ARQ 171
Original Secondary Outcome Measures ^ICMJE (submitted: November 9, 2006)	To determine the pharmacokinetic profile of ARQ 171. To assess the preliminary anti-tumor activity of ARQ 171
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study of ARQ 171 in Patients With Advanced Solid Tumors
Official Title ^ICMJE	A Phase 1 Dose Escalation Study of ARQ 171 in Adult Patients With 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Cancer
Intervention ^ICMJE	Drug: ARQ 171
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Suspended
Estimated Enrollment ^ICMJE	30
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00398840
Other Study ID Numbers ^ICMJE	ARQ 171-101
Has Data Monitoring Committee	No
Responsible Party	Arqule, Arqule, Inc.
Study Sponsor ^ICMJE	ArQule
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	ArQule
Verification Date	January 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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