Palifosfamide, a DNA cross-linker in class with bendamustine, ifosfamide and cyclophosphamide, is undergoing a randomised double-blinded placebo-controlled Phase 3 trial for the treatment of metastatic soft tissue sarcoma.
The Phase 1b study involving 22 patients to evaluate the safety and efficacy of the combination therapy, demonstrated maximum tolerated dose of Palifosfamide to be 130 mg/m2 when administered in combination with etoposide and carboplatin (AUC4).
Of the 22 patients, 13 are evaluable for efficacy – 5 patients with partial responses (PR), 4 with stable disease (SD), and 4 with progressive disease (PD).
Lead author of the study Wael Harb said the combination therapy found to be well tolerated and demonstrated promising clinical activity in SCLC, germ cell tumour and ovarian cancer.