A Study of ARQ 171 in Patients With Advanced Solid Tumors
This study has suspended participant recruitment.
Sponsor:
ArQule
Information provided by:
ArQule
ClinicalTrials.gov Identifier:
NCT00398840
First received: November 9, 2006
Last updated: January 8, 2009
Last verified: January 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer |
Drug: ARQ 171 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1 Dose Escalation Study of ARQ 171 in Adult Patients With Advanced Solid Tumors |
Resource links provided by NLM:
Further study details as provided by ArQule:
Primary Outcome Measures:
- To determine the safety, tolerability and maximum tolerated dose (MTD) of ARQ 171
Secondary Outcome Measures:
- To determine the pharmacokinetic profile of ARQ 171
- To assess the preliminary anti-tumor activity of ARQ 171
| Estimated Enrollment: | 30 |
| Study Start Date: | November 2006 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00398840
Locations
| United States, California | |
| Premiere Oncology | |
| Santa Monica, California, United States, 85260 | |
| United States, Massachusetts | |
| Dana Farber/Harvard Cancer Center | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Texas | |
| Mary Crowley Medical Research Center | |
| Dallas, Texas, United States, 75201 | |
Sponsors and Collaborators
ArQule
More Information
No publications provided
| Responsible Party: | Arqule, Arqule, Inc. |
| ClinicalTrials.gov Identifier: | NCT00398840 History of Changes |
| Other Study ID Numbers: | ARQ 171-101 |
| Study First Received: | November 9, 2006 |
| Last Updated: | January 8, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by ArQule:
|
Cancer Solid Tumors advanced solid tumors |
ClinicalTrials.gov processed this record on May 19, 2013