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
1 other identifier
interventional
14
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 cancer
Started Nov 2006
Shorter than P25 for phase_1 cancer
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 9, 2006
CompletedFirst Posted
Study publicly available on registry
November 14, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedMarch 6, 2017
March 1, 2017
1.8 years
November 9, 2006
March 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine the safety, tolerability and maximum tolerated dose (MTD) of ARQ 171
Secondary Outcomes (2)
To determine the pharmacokinetic profile of ARQ 171
To assess the preliminary anti-tumor activity of ARQ 171
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Premiere Oncology
Santa Monica, California, 85260, United States
Dana Farber/Harvard Cancer Center
Boston, Massachusetts, 02115, United States
Mary Crowley Medical Research Center
Dallas, Texas, 75201, United States
MeSH Terms
Conditions
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 9, 2006
First Posted
November 14, 2006
Study Start
November 1, 2006
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
March 6, 2017
Record last verified: 2017-03