Download OSA Project RFP 05-16 - Morris Animal Foundation

Morris Animal Foundation
REQUEST FOR PROPOSALS
The Osteosarcoma Project
Deadline: August 1, 2016
Morris Animal Foundation, established in 1948, is a nonprofit organization that provides funding
for research designed to advance veterinary medicine for animals worldwide. Each year, the
Foundation manages more than 300 animal health studies around the world. In addition to those
studies funded through our traditional grant process, we occasionally receive funds from individual
donors, foundations or corporations who wish to address specific issues of interest.
Thanks to the generosity of many donors, Morris Animal Foundation is now calling for
proposals of novel agents to be evaluated in pet dogs with osteosarcoma through Morris
Animal Foundation’s Osteosarcoma Project.
The Osteosarcoma Project provides a framework for conception, design and execution of clinical
trials of novel agents in pet dogs with osteosarcoma (OSA) to expressly define the impact of drug
exposure on tumor metastasis, which is the leading cause of death in canine and human
osteosarcoma patients. The current drug development paradigm does not adequately address this
aspect of cancer biology, as evaluation of novel therapeutics in a gross disease setting does not
specifically interrogate factors that influence metastatic progression. A series of studies wherein
regression of measurable lesions is not the expected outcome; rather, agents are evaluated in the
adjuvant or minimal residual disease (MRD) setting and the time to onset of progressive disease
in the form of pulmonary metastasis is the primary endpoint. This approach provides the most
robust assessment of a drug’s ability to delay the most deadly aspect of this disease, and represents
a departure from a conventional study design wherein a drug’s ability to reduce an established,
measureable disease burden is the main endpoint.
A series of investigational agents will be evaluated in dogs with appendicular osteosarcoma under
a 5-year effort through the Comparative Oncology Trials Consortium (COTC). The COTC is an
active network of twenty-two academic comparative oncology centers, centrally managed by the
NIH-NCI-Center for Cancer Research's Comparative Oncology Program. One arm of this effort
involves the accrual of dogs receiving Standard of Care (SOC) therapy in order to discern the
impact of investigational agents given in the adjuvant setting in addition to SOC. SOC is defined
as amputation of the affected limb, followed by 4 doses of intravenous carboplatin chemotherapy
given on a q21 day schedule. Cases will be prospectively and randomly enrolled at a number of
COTC sites in an effort to minimize bias and eliminate disadvantages of historical control data.
The ratio of dogs in the control arm: dogs in each investigational arm will be 1:1. Each
investigational arm will contain 80 dogs prospectively enrolled over a 12-24-month period.
The SOC arm and the first investigational arm opened in November of 2015. The first
investigational agent selected was Rapamycin. Accrual is expected to be complete for both studies
by December 2016.
We are now seeking proposals for additional investigational agents to be evaluated against the
SOC arm currently in progress. The successful applicant will work with the NCI-COTC to develop
a full clinical protocol in line with the budgetary guidelines and allowable costs for clinical
management of dogs enrolled to the protocol.
To download the Proposal Guidelines, click here.
To download the Online Application Instructions (includes a link to the online form), click here.
For more information or if you have specific questions, please email Christina Mazcko at
[email protected].