Status:
COMPLETED
Study of AR-67 (Formerly DB-67) in Adult Patients With Refractory or Metastatic Solid Malignancies
Lead Sponsor:
Arno Therapeutics
Collaborating Sponsors:
University of Kentucky
Arch Medical Services Inc., DBA The Center for Cancer Care and Research
Conditions:
Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Hypothesis: AR-67 (formerly DB-67) represents a rationally engineered drug that possesses improved stability, toxicity, and efficacy compared to current Food and Drug Administration (FDA)-approved ca...
Detailed Description
Overview of Study: Camptothecins are a potent class of anticancer drugs that inhibit DNA topoisomerase I. Topotecan and irinotecan are two FDA approved second generation congeners currently in clinic...
Eligibility Criteria
Inclusion
- \>18 year old subjects with solid malignancies that have progressed after at least one prior chemotherapy regimen and have exhausted other therapies
- Treated and clinically stable brain metastases
- Measurable OR non-measurable disease
- Greater than three weeks since surgery
- Normal organ and marrow function
- ECOG Performance Status of \< 2
- No other prior malignancy except for treated basal cell or squamous cell skin cancer, in situ cervical cancer, Stage I or II cancer (patient in complete remission) or other cancer from which the patient has been disease-free for 5 years.
- Computed tomography (CT) scan of involved areas within 28 days of registration
- Life expectancy of greater than 12 weeks.
Exclusion
- Pregnant or nursing females
- Chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) of entering the study.
- Patients may not be receiving any other investigational agent. Uncontrolled intercurrent illness including active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Allergic reactions to compounds of similar chemical or biologic composition to DB-67 (i.e. camptothecins such as irinotecan, topotecan, or others of this class of pharmaceuticals).
- Subjects with prior anaphylactic injection reaction of \> grade 3 to paclitaxel or any other product formulated with cremophor
- Subjects with HIV
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00389480
Start Date
October 1 2006
End Date
May 1 2009
Last Update
August 11 2009
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Kentucky
Lexington, Kentucky, United States, 40536
2
Arch Medical Services Inc. DBA The Center for Cancer Care and Research
St Louis, Missouri, United States, 63141