To my knowledge it's only ever been used in a Phase II and I can't imagine the FDA accepting one as a pivotal trial.
The poster boy for success of this design is Nexavar. It makes most sense for agents where it's quite unclear what cancers will respond and also for drugs that are likely to produce stable disease rather than an objective response.
No, FDA doesn't accept RDT as pivotal trial because RDT is exploratory trial. However, FDA does accept certain cohort from RDT trial in support of pivotal trial in NDA submission. Nexavar RCC cohort was used as part of Nexavar NDA along with a pivotal trial in RCC.
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