Table 2.

Summary of Recommendations for the Conduct of Pilot Trials in Advanced Pancreas Cancer

Parameter	Recommendation
Patient selection	Restrict studies to patients with Eastern Cooperative Oncology Group performance status 0-1
	Study patients with localized unresectable disease separately from those with metastatic disease
	Establish uniform eligibility criteria
	Use of predictive biomarkers for enrichment
Agents to be tested	Maximize input from preclinical data
	Adopt multitargeted approaches based on scientific rationale
	Consider non–gemcitabine-based combinations
Statistical designs	Survival preferred primary end point
	Single arm and multiarm randomized studies each have their place
Correlative science	Incorporate hypothesis-driven correlative research in pilot trials
	Report negative as well as positive study outcomes
	Consider prospective patient selection in pilot study setting based on data relating outcome with a specific molecular profile
Transition to phase III	Consider input from multiple studies
	Implement phase III testing only after a robust signal from pilot study(s)