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

NCT00389480 | Completed Phase 1 DMC

• 1 other identifier: ARN-AR67-CT101
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Tumors

Keywords

Solid Tumors; Solid Malignancies; Phase I

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose (MTD)

  Any time during the four 21-day cycles

• Dose limiting toxicity (DLT)

  Any time during the four 21-day cycles

Secondary Outcomes (2)

• Pharmacokinetics

  at each dose during week 1

• Pharmacogenetic effects of polymorphisms

  at each dose during week 1

Study Arms (1)

I

EXPERIMENTAL

Dose escalating

Drug: AR-67 (formerly DB-67)

Interventions

AR-67 (formerly DB-67) DRUG

infusion daily x 5 days, every 21 days

I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Arno Therapeutics: lead
• University of Kentucky: collaborator
• Arch Medical Services Inc., DBA The Center for Cancer Care and Research: collaborator

Study Sites (2)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Arch Medical Services Inc. DBA The Center for Cancer Care and Research

St Louis, Missouri, 63141, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

7-tert-butyldimethylsilyl-10-hydroxycamptothecin

Study Officials

• Susanne Arnold, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

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: October 17, 2006
• First Posted: October 18, 2006
• Study Start: October 1, 2006
• Primary Completion: February 1, 2009
• Study Completion: May 1, 2009
• Last Updated: August 11, 2009

Record last verified: 2009-08

Locations

US (2)