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NCT02345408 Clinical Trial

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
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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