Case Study 3

First in Man Solid Tumor Oncology

SITUATION

TFS was selected to provide full CRO services including site identification/initiation/training; patient enrolment; project management/monitoring; data management; biostatistics & programming; medical writing, safety, medical monitoring and regulatory consulting. This open study required close follow up on safety and disease.

  • Part One: (Dose Escalation): 3 sites  
  • Part Two: (Dose Expansion): 6 sites  

Study Phase: First in Man, I/IIb

Indication: Solid Tumors

Sites: 6

Services: Full Service

CHALLENGES

Part One:

  • Quick patient enrolment required per cohort. Significant competition with similar oncology treatment trials
  • Close follow-up needed on safety and progressive disease.
  • Complex process to get AIOM/SIAPEC certification for local labs for solid biopsies.
  • Close PK/PD sample management required.
  • Rapid safety data delivery required for the DSMB for each cohort

Part Two:

Slow recruitment was caused by the following factors:

  • The disease indications allowed had been reduced to four cohorts, with more incidence of target receptor expression versus all epithelial cancer in part one
  • Mandatory paired biopsies were required for 60% of the patients. In some of the indications the biopsies were not easy do obtain due the location of the lesions
  • Previous chemotherapy lines were restricted to 3 treatments in part two.

TFS SOLUTION

An extremely experienced and dedicated TFS team who reported into the Oncology & Hematology Centre of Excellence was assigned to the project. The team had the necessary expertise particularly in managing complex project start-up and regulatory activities. The strength of the project team allowed TFS to coordinate all project activities in an efficient manner and rapidly resolve any project challenges including questions received from the regulatory authorities.

The team also leverage from previous early phase oncology studies to ensure successful cohort management.

For each cohort patients were recruited within 2-3 weeks with successful slot allocation across the sites.

The project manager (PM) developed a shared tracker with the client to register any potential patients and follow up closely with the client to prevent more patients being pre-screened for slots that were available. Sites were informed on an ongoing basis regarding the recruitment status and the number of slots available. Sites were instructed to either contact their CRAs or the PM directly to confirm if slots were available in each dose cohort.  

Timely data delivery of all required safety data points to the DSMB for each cohort were provided 4-5 days after last patient/last visit (LPLV).

Key success factors for successful study execution are a robust recruitment , cohort management and safety review plans and close oversight from the oncology & hematology centre of excellence leadership team.

An additional site that was not originally selected was later added to the study due to the fact that the site had access to a large number of suitable patients.

CLIENT ADVANTAGE

With the ongoing data review meetings continuing for part two the customer could develop and plan for the next study with this compound in a timely fashion

This project is currently ongoing, and recruitment is meeting all targets.