CRISTAL-APC will evaluate VP-002 at a total daily dose of 600mg to a maximum of 1,800mg per day in combination with nab-paclitaxel and gemcitabine. Nab-paclitaxel will be administered at the allocated dose level of either 100mg/m2 or 125mg/m2. Gemcitabine will be administered at the allocated dose level of either 800mg/m2 or 1000mg/m2.
Cycle 0 is a 14-day monotherapy cycle where patients will self-administer VP-002 only. It will be taken once a day on day 1 and twice daily on days 2-14.
Cycles 1-6: Patients will self-administer VP-002 twice daily on days 1-28 of a 28- day cycle. Intravenous (IV) nab-paclitaxel 30-minute infusion followed immediately by IV gemcitabine 30-minute infusion will be administered on days 1, 8 and 15 of a 28-day cycle.
Participants are able to continue up to 12 cycles if a patient is benefiting from the treatment.
Patients will be randomised using a Web-based randomisation system into one of the following arms:
Experimental Arm A
The dose levels of VP-002, nab-paclitaxel and gemcitabine will be decided from the phase I dose escalation.
Cycles 1-6: Patients will self-administer VP-002 twice daily on days 1-28. Intravenous (IV) nab-paclitaxel 30-minute infusion followed immediately by IV gemcitabine 30-minute infusion will be administered on days 1, 8 and 15 of a 28-day cycle.
Control Arm B:
Cycles 1-6: Intravenous (IV) nab-paclitaxel 30-minute infusion followed immediately by IV gemcitabine 30-minute infusion will be administered on days 1, 8 and 15 of a 28-day cycle.
Participants are able to continue up to 12 cycles if a patient is benefiting from the treatment.
