If you read the study, this study focuses on those who have failed conventional treatment, as is the case with most Phase I trials.

These poor folks have no other choice but to pursue experimental therapy - otherwise their expected survival rate is MUCH less than what would occur in the normal population.

In addition, Phase I trials are NOT designed to measure efficacy - they are designed to measure safety. Phase II & III trials will be able to determine prospectively efficacy of treatment versus control.