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| Sponsor: | McGill University |
|---|---|
| Information provided by: | McGill University |
| ClinicalTrials.gov Identifier: | NCT00765466 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer |
Drug: AVR118 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Open Label, Multi-Center Study With AVR118 in Anorectic Patients With Recurrent or Advanced Malignancies |
| Estimated Enrollment: | 30 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 19 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Martin Chasen | 514-934-1934 ext 35997 | martin.chasen@mcgill.ca |
| Canada, Quebec | |
| McGill University Clinical Research Program | Recruiting |
| Montreal, Quebec, Canada, H2W 1S6 | |
| Contact: Mirabel de Diego (914) 376 7383 maribeld@adviral.com] | |
| Principal Investigator: Martin Chasen | |
| Study Director: | Maribel de Diego, Ph.D. | Advances Viral Research Corporation |
More Information
| Responsible Party: | Dr. Martin Chasen, McGill University |
| ClinicalTrials.gov Identifier: | NCT00765466 History of Changes |
| Other Study ID Numbers: | McG 0710 |
| Study First Received: | October 2, 2008 |
| Last Updated: | October 21, 2008 |
| Health Authority: | Canada: Health Canada; CANADA: Scimega Research; CANADA: Advanced Viral Research Corporation |
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Explore the effect of AVR118 4.0 mL, given subcutaneously on appetite |
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Appetite Depressants Anti-Obesity Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |