Fig. 1.

A: Patient dosages.

EC = local effect cohort; RECIST = Response Evaluation Criteria in Solid Tumors.

*One patient at dose level 2·40 mg/m² was excluded from the efficacy population because a post-baseline RECIST assessment of the target tumors was not performed.

^†In these cohorts, one patient experienced leakage of tigilanol tiglate, so an additional patient was added to the cohort.

^‡Six patients had insufficient tumor mass to be enrolled in the dose- escalation stages and were enrolled in the LEC. These patients received the highest concentration of tigilanol tiglate that had been shown to be tolerated, a total dose no higher than the dose tested in the most recent dose-escalation cohort, and a minimum volume of 0·1 mL per tumor. This cohort followed the same assessment schedule as the dose-escalation cohorts.

^§Six patients discontinued participation due to disease progression and one due to unintentional lack of follow-up. The mean time to discontinuation was 25·4 days (range: 18 to 43 days).

B: Design Paradigm.

# A patient in this cohort experienced leakage following dosing, therefore a total of four were enrolled to satisfy dose escalation rules

* A patient in this cohort was under-dosed, therefore a total of four were enrolled to satisfy dose escalation rules.