Phase 1b Study of CCX872-B in Patients With Pancreatic Adenocarcinoma

An Open-label Phase 1b Study to Evaluate the Safety and Efficacy of CCX872-B in Patients With Pancreatic Adenocarcinoma

This is an open-label phase 1-b study to evaluate the safety and efficacy of CCX872-B in patients with pancreatic adenocarcinoma also receiving FOLFIRINOX chemotherapy.

Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.

Inclusion Criteria:

• Histologically or cytologically confirmed non-resectable pancreatic adenocarcinoma with or without metastases
• Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2
• Anticipated life expectancy ≥ 12 weeks
• Radiographically measurable disease acc. to RECIST 1.1
• Use of adequate contraception (as described in protocol)
• Ability to provide written informed consent and comply with study requirements

Exclusion Criteria:

• Received other cancer treatment or investigational drug within 4 weeks prior to screening
• Women who are pregnant or breastfeeding
• Had major surgery within 4 weeks of first dose of study drug
• Inadequate liver, renal or bone marrow function within 2 weeks of first dose
• Serious concurrent illness, altered medical status or any uncontrolled medical condition
• Any infection requiring antibiotic or anti-viral treatment within 4 weeks of screening
• Known active HIV, HBV or HCV infection
• Inability to swallow tablets
• History or presence of any medical condition or disease which, in the opinion of the investigator, may place the subject at unacceptable risk for study participation