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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02345408
• Other study ID #: CL002_872
• Status: Completed
• Phase: Phase 1
• Start date: February 2015
• Est. completion date: May 6, 2020

Study information

• Verified date: March 2022
• Source: ChemoCentryx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: May 6, 2020
• Est. primary completion date: May 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Cancer

Intervention

Drug:
• CCX872-B
Tablets (oral administration)

Locations

Country	Name	City	State
Netherlands	Netherland	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
ChemoCentryx

Countries where clinical trial is conducted

United States,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival		24 weeks
Primary	subject incidence of Grade 3 or 4 adverse events		24 weeks