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

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arno Therapeutics
• Collaborators: Arch Medical Services Inc., DBA The Center for Cancer Care and Research; University of Kentucky
• Treatments: 10-hydroxycamptothecin

Criteria

Inclusion Criteria:

• >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 Criteria:

• 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