Rucaparib Investigator Initiated Trials (IIT) Program
As part of our mission to improve the lives of people living with cancer, Clovis Oncology supports independent, unsolicited medical research through our Investigator Initiated Trials (IIT) Program. Research supported through the IIT program plays a vital role in advancing our understanding of the benefit/risk profile of Rucaparib, as well as exploring tumor types with high unmet medical needs. Toward this end, we consider proposals for studies with scientific and medical merit developed and sponsored by an independent investigator or academic sponsor. IIT requests can include drug product, and/or financial support.
IIT Submission Requirements
Please submit the IIT concept documents described below via IGNITION, the Clovis Oncology online IIT Portal. Documents and information required for submission include the following:
Please Note: All submissions and supporting documents must be in English
1. Detailed Study Description
· Curriculum Vita of the Sponsor-Investigator(s)
· IIT Title
· Institution Name & Type
· Summary of IIT Concept. Please include:
o Tumor type
o Line of Therapy
o Investigational Drugs
· Number of Patients
o Number to be enrolled
o Number of screen failures expected
· Timelines:
o Estimated First Patient In
o Estimated time to enroll all patients
o Estimated treatment duration
· PI’s country
· Additional Countries?
· Number of Sites
· Concept Support Type: Rucaparib study drug, funding, both
· Other Therapy (if applicable)
· Translational Medicine:
o Diagnostic information (if applicable): e.g., BRCA, LOH, HRD, ctDNA, gene panel, HRR gene mutation, other.
o Sample Analysis: type of samples collected. Retrospective or prospective testing for screening patients.
· Primary Endpoints
· Secondary Endpoints
· Publication Plan details and timing [e.g., after interim analysis, end of study]
2. Budget Details
· Estimated Budget, using template provided by Clovis Oncology
· Amount requested from Clovis Oncology
· Primary product
· Multiple Products? (Y/N)
o If a drug combination IIT, drug supply and/or funding amount requested from other biotech/pharmaceutical company
· Estimates for Translational Medicine support (as applicable)
· Note to include diagnostics and PK in the budget along with lab kits and shipping costs.
If an IIT concept is approved, investigators are required to submit a full protocol and detailed budget. Investigators will provide these documents for review by one or more cross-functional committees. Clovis Oncology may make suggestions to improve the scientific merit of the proposal. However, as the study sponsor, the principal investigator will have full responsibility for all aspects of the study -- including design, conduct, data analysis and reporting in accordance with all local laws and regulations. The principal investigator is also responsible for arrangements related to the IRB or ethics approval, request for IND exemption, and other regulatory approvals and safety reporting. The terms under which Clovis Oncology will provide support will be described in a written contract. During this process, locally or regionally based Clovis Oncology Medical Science Liaisons (MSLs) will serve as the primary point of contact for investigators and/or academic sponsors.
11/1/2017