PRO-002 Clinical Study

Phase Ib study of Acelarin + carboplatin in patients with recurrent ovarian cancer

  • Combination Acelarin + cisplatin
  • Dose excalation: 3 + 3
    • Acelarin 500mg/m2 to 750mg/m2
    • Carboplatin AUC 4 to 5
  • All patients had metastatic spread
  • Objective: Recommended Phase II dose
PRO-002 study image of lady
Demographic Overall Study
Patients 25
Evaulable Patients (≥1 cycle) 23
Age 64 (range 37-77)
Prior Chemotherapy Regimens 3 (range 2-6)

Results

In the Phase Ib study, 25 patients with recurrent ovarian cancer received Acelarin at doses from 500mg/m2 to 750mg/m2 in combination with carboplatin for a maximum of 6 treatment cycles lasting 3 weeks each. Of the 25 patients enrolled, 23 were evaluable and these patients were characterised by their platinum status: 7 were platinum-refractory, 10 were platinum-resistant, 4 were partially platinum-sensitive and 2 were platinum-sensitive. Efficacy was evaluated using the RECIST standard scoring system. The 23 evaluable patients had received 1 or more cycles of Acelarin in combination with carboplatin and had at least 1 radiographic assessment to measure changes in tumour size. Of these patients, 1 achieved a complete response, with a complete disappearance of all target lesions, and 8 achieved a partial response, with at least a 30% decrease in tumour size, although not all of these patients have received a confirmatory scan. This resulted in an overall response rate of 39%. Another 13 patients had tumours that either decreased by up to 30% or increased by less than 20% and were scored as having stable disease. This resulted in a disease control rate of 96%. The median progression-free survival duration for all 25 patients recruited was 7.3 months and for the evaluable population was 7.4 months.

Best Overall Response Rate

Acelarin 217 higher graph