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

February 25, 2025 updated by: Amgen

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

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 24 weeks
24 weeks
subject incidence of Grade 3 or 4 adverse events
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Investigators

  • Study Director: MD, Amgen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 (Estimated)

January 26, 2015

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 25, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL002_872

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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