Study of AR-67 (Formerly DB-67) in Adult Patients With Refractory or Metastatic Solid Malignancies

Completed · Phase 1

Conditions studied: Tumors

In brief

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 camptothecins, based on the extensive research of prior studies. Therefore, the investigators hypothesize that AR-67 (formerly DB-67) will be well-tolerated and efficacious in phase I clinical trials. This initial phase I trial will establish the maximum tolerated dose in humans, establish the toxicity profile, and define the appropriate dose of AR-67 (formerly DB-67) for future phase II and III clinical trials.

Key facts

Study ID

NCT00389480

Run by

Arno Therapeutics

People needed

26

Starts

2006-10-01

Expected to finish

2009-05-01

Last updated by the study team

2009-08-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• >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.

You may not qualify if…

• 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

Where it is running

• University of Kentucky — Lexington, Kentucky, United States
• Arch Medical Services Inc. DBA The Center for Cancer Care and Research — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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