One case study will be discussed where exposure-response modeling of phase II data guided the dosing regimen for confirmatory studies. This case study involved an anti-angiogenic compound in the treatment of ovarian cancer. No maximum tolerated dose was identified in a traditional, first-in-human oncology study. The doses for the phase 2 study were based on the PK and PD from FIH and preclinical studies. A randomized, phase 2 study was designed to not only evaluate the safety/efficacy of the investigational product in combination in recurrent ovarian cancer, but also to find an appropriate dose. Due to practical constraints this phase II, dose finding study had only three arms: 1) placebo controlled arm 2) low dose arm 3) high dose arm. Exposure-response analyses of the phase 2 data indicated that the highest exposures were associated with the best efficacy and with an appropriate safety