Case Study Three

Phase I/II Oncology Study

We were engaged to report a phase I/II oncology study in advanced NSCLC with an initial phase I escalation followed by a phase II expansion. The objectives covered defining the maximum tolerated dose and having a preliminary assessment of efficacy using RECIST 1.1 as well as PK/PD endpoints.

For this study, PHASTAR was using the Sponsor’s system – a UNIX based platform with a web-based front end to manage the SAS programming. The Sponsor had dataset standards in place and we were required to have all non standard variables approved by the Sponsor’s standards committee. There were over 100 new variables added to the Sponsor’s standards in this study. All dataset programming was validated using OPENCDISC tools.

Shortly after the study was awarded to PHASTAR, a new request from the Sponsor was received to present data at the ASCO conference. The request came with little notice, but PHASTAR delivered the required results and some additional ad hoc results that were required for the presentation. A few months later, a similar request was made to present data at ESMO. Again, this request was accommodated and PHASTAR provided all results for the presentation in good time.

The Sponsor requested programmed narrative templates and we delivered RTF documents according to the Sponsor’s template, programmed in SAS, enabling medical writers to easily produce the final CSR narratives.

There was an additional report of the subset of Japanese patients, and we provided all outputs to support this report after the main delivery. We generated all necessary datasets and documentation for the define.pdf. This submission was successful and the drug became the fastest product from lab to market on record.