Clinical
Effect Studied	Model Used	Result	Reference
Efficacy.	A phase I study in patients with androgen refractory prostate cancer (n = 33) in which kahalalide F (20 to 930 µg/m2) was administered as a daily 1-h intravenous infusion for 5 days every 3 weeks.	One patient showed a significant decrease in PSA level (> 50%) associated with clinical improvement (pain relief), while three patients exhibited stable disease for 2 (n = 2) or 7 (n = 1) months. The MTD was 560 µg/m2/day.	543658
Efficacy.	A phase I study in patients with various solid tumors (n = 25) in which kahalalide F was administered as a continuous weekly 1-h intravenous infusion at doses ranging from 266 to 1200 µg/m2.	Three patients achieved a clinical benefit: one hepatocarcinoma patient who received 24 infusions consisting of 400 µg/m2/week, one squamous carcinoma cavum patient who received nine infusions at the same dose, and one NSCLC patient who received 16 infusions at a dose of 530 µg/m2/week. The MTD was 1200 µg/m2/week.	470663
Safety.	Two phase I trials in which 60 cancer patients were administered kahalalide F as a 1-h intravenous infusion.	Grade 4 Al was consistently the DLT and tended to coincide with LDH elevation and an ALT/AP ratio of > 5.0, indicating hepatocellular damage; these effects were reversible and dose dependent.	526738