August 2019

Call for Letter of Intent proposals for a Phase 2 clinical study
in recurrent osteosarcoma patients

Background

The Osteosarcoma Institute (OSI) was established in November 2017 to develop a comprehensive, rational strategy that will lead to major improvement in the life expectancy of patients with relapsed and metastatic osteosarcoma. OSI is seeking Letter of Intent (LOI) proposals for a grant of up to $800,000 to conduct a Phase 2 (or Phase 1/2) study to test the activity of a novel therapeutic approach to treat recurrent osteosarcoma patients. The primary objective of such a study should be to improve EFS at 4 months, beyond historical rates known to be in the range of 12%. Funding will be based on the proposal and correlates, and may be used to support any aspect of the clinical trial including personnel, correlative studies, etc. Indirect costs may not exceed 10%.

Contemporaneously, OSI has announced a call for pre-proposals for a translational and preclinical research study in the area of osteosarcoma metastasis.

Application guidance

Applications must be submitted through Proposal Central.  Applicants should visit https://proposalcentral.com, create an account, if necessary, and login.  Then, select the Grant Opportunities tab and enter “Osteosarcoma Institute” in the search box.  The application is available by clicking Apply Now on the Clinical Trial in Recurrent Osteosarcoma line.

The proposed study may be carried out in a single institution, a clinical trials consortium, or through an existing clinical trial infrastructure. OSI will not prioritize the launch of new infrastructures to conduct trials.  Please provide specific timetables for protocol development, regulatory approvals, industry agreements, IRB approvals, activation, accrual and reporting.  We will consider the proposer’s prior history of efficiently opening trials and meeting  accrual expectations for relapsed osteosarcoma patients, with the expectation that results will be available within a 3-year time frame or less.  Other desirable characteristics for proposals include:

  • Answering an important question
  • Strong preclinical rationale
  • Rigorous trial design and correlative endpoints to allow for “productive failures”
  • Cost efficiency (per patient and total)
  • Commitment of concurrent financial support of the trial (e.g., direct institutional support, industry and/or philanthropic support, securing drug, etc.)

A cover letter is not required but may be added as an attachment to the application.

 

Timeline:

  • Pre-proposals due October 15, 2019
  • Reviews completed by January 15, 2020
    Requests for full proposals will be made immediately after reviews are completed
  • Full protocol submission due by April 15, 2020
  • Award announcement estimated June 1, 2020

Published by the Osteosarcoma Institute on September 5, 2019.