A Phase II Open Label, Multi-Center Study With AVR118 in Anorectic Patients With Recurrent or Advanced Malignancies

NCT00765466 | Terminated Phase 2 DMC

• 1 other identifier: McG 0710
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label, Phase II, multi-center study designed to evaluate the effect of AVR118 when administered to patients with systemic symptoms related to recurrent or metastatic cancers who may or may not be undergoing anti-cancer treatment. During the initial, induction treatment phase of the study, AVR118, 4.0 mL, will be given subcutaneously each day for 28 days. Patients who respond to the trial period dosing will be eligible to continue on AVR118 if they and their physicians believe it would be beneficial, and if no safety concerns are raised.

Conditions

Cancer

Keywords

Explore the effect of AVR118 4.0 mL, given subcutaneously on appetite

Outcome Measures

Primary Outcomes (1)

• Karnofsky Performance Status Disease-related symptoms: ESAS and PG-SGA Anorexia Weight Lean Body Mass, Triceps skin fold, and grip strength

Interventions

AVR118 DRUG

daily doses of 4.0 mL AVR118 subcutaneously

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed solid tumor cancer, leukemia, lymphoma, or multiple myeloma.
• Concurrent anti-cancer treatment, such as chemotherapy or radiation therapy is permitted except for neo-adjuvant or adjuvant programs.
• Between the ages of 18-85.
• Symptoms of recurrent or metastatic cancer in which anorexia is a predominant symptom, not necessarily associated with cachexia, and are not attributed to anemia, concomitant illnesses, or obstruction or loss of organ function.
• Karnofsky performance status of 40%
• Palliative Prognostic Score (PaP) of less than 6
• Patient is expected to be able to remain on a study protocol for two months.
• Pretreatment laboratory data within 7 days of enrollment:
• Hemoglobin \>8.5 g/dL , or on stable doses (hematocrit stable within 1 gram and dose stable for one month) of erythropoietin or similar medication.
• Absolute neutrophil count (ANC) 1,500/mm3.
• Platelets 50,000/mm3.
• Total bilirubin 2.0
• ALT and AST 2.5 times the ULN, or, if the patient has liver metastases, 5 times the ULN.
• Creatinine 1.5 mg/dL.
• Normal TSH

You may not qualify if:

• Patient has uncontrolled brain metastases or central nervous system disease.
• Patient has mechanical, non-reversible reason for not being able to eat, or have a potential for developing malignant bowel obstruction during the course of the induction phase of treatment, or patients requiring a PEG for obstruction.
• Patient has had any major surgery within four weeks of enrollment.
• Patient has an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
• In the Investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
• Female patient is pregnant or breast-feeding.

Sponsors & Collaborators

• McGill University: lead

Study Sites (1)

McGill University Clinical Research Program

Montreal, Quebec, H2W 1S6, Canada

Location

MeSH Terms

Conditions

Neoplasms

Interventions

EOM613

Study Officials

• Maribel de Diego, Ph.D.

  Advances Viral Research Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 2, 2008
• First Posted: October 3, 2008
• Study Start: October 1, 2007
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: March 14, 2019

Record last verified: 2007-03

Locations

CA (1)