Phase 1b Study Of CCX872-B In Patients With Pancreatic Adenocarcinoma

Study Overview

Phase 1b Study 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.

Pancreatic Cancer

DRUG: CCX872-B

CL002_872

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2015-01-20	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-02-25
First Submitted that Met QC Criteria 2015-01-20	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-02-27
First Posted (ACTUAL) 2015-01-26	Results First Posted N/A	Last Verified 2025-02

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

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)

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)

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

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

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

Investigators

STUDY_DIRECTOR: MD, Amgen

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record