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

Phase 1

Completed

• Conditions: Pancreatic Cancer
• Interventions: Drug: CCX872-B

• Registration Number: NCT02345408
• Lead Sponsor: Amgen

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2015-01-20
• Study First Submitted QC: 2015-01-20
• Study First Posted: 2015-01-26
• Study Start: 2015-02
• Primary Completion: 2020-05-06
• Study Completion: 2020-05-06
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CCX872-B	CCX872-B	150 mg once or twice daily given orally for at least 12 weeks

Primary Outcome Measures

Name	Time	Method
progression-free survival	24 weeks
subject incidence of Grade 3 or 4 adverse events	24 weeks

Trial Locations

Locations (1)

Netherland; 🇳🇱 Rotterdam, Netherlands