- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00765466
A Phase II Open Label, Multi-Center Study With AVR118 in Anorectic Patients With Recurrent or Advanced Malignancies
March 12, 2019 updated by: McGill University
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Quebec
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Montreal, Quebec, Canada, H2W 1S6
- McGill University Clinical Research Program
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- Testosterone levels determined.
- Voluntary written informed consent before performance of any study-related procedure that is not part of normal medical care.
- Ability to self-administer subcutaneous medication if an assistant or nurse is not available, and to keep a compliance journal documenting injections at home.
- If on an antidepressant, the dose must have been stabilized for at least 30 days.
- Female patient is post-menopausal, surgically sterilized, or willing to use acceptable methods of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide, or abstinence) for the duration of the study.
- Male patient agrees to use an acceptable barrier method for contraception during the study
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Karnofsky Performance Status Disease-related symptoms: ESAS and PG-SGA Anorexia Weight Lean Body Mass, Triceps skin fold, and grip strength
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Maribel de Diego, Ph.D., Advances Viral Research Corporation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
October 2, 2008
First Submitted That Met QC Criteria
October 2, 2008
First Posted (Estimate)
October 3, 2008
Study Record Updates
Last Update Posted (Actual)
March 14, 2019
Last Update Submitted That Met QC Criteria
March 12, 2019
Last Verified
March 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- McG 0710
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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