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 Overview

• Status: Completed
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: CCX872-B

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands
  • Nijmegen, Netherlands
  • Rotterdam, Netherlands
    • Netherland
  • Sittard, Netherlands
• United States
  • Missouri
    • Saint Louis, Missouri, United States
  • New York
    • Rochester, New York, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CCX872-B; 150 mg once or twice daily given orally for at least 12 weeks	Drug: CCX872-B; Tablets (oral administration)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
progression-free survival	24 weeks
subject incidence of Grade 3 or 4 adverse events	24 weeks

Collaborators and Investigators

• Sponsor: ChemoCentryx

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): May 6, 2020
• Study Completion (Actual): May 6, 2020

Study Registration Dates

• First Submitted: January 20, 2015
• First Submitted That Met QC Criteria: January 20, 2015
• First Posted (Estimate): January 26, 2015

Study Record Updates

• Last Update Posted (Actual): March 15, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: CL002_872