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
1 other identifier
interventional
54
2 countries
6
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 pancreatic-cancer
Started Feb 2015
Longer than P75 for phase_1 pancreatic-cancer
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2015
CompletedFirst Posted
Study publicly available on registry
January 26, 2015
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 6, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 6, 2020
CompletedFebruary 27, 2025
February 1, 2025
5.3 years
January 20, 2015
February 25, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
progression-free survival
24 weeks
subject incidence of Grade 3 or 4 adverse events
24 weeks
Study Arms (1)
CCX872-B
EXPERIMENTAL150 mg once or twice daily given orally for at least 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (6)
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Rochester, New York, United States
Unknown Facility
Amsterdam, Netherlands
Unknown Facility
Nijmegen, Netherlands
Netherland
Rotterdam, Netherlands
Unknown Facility
Sittard, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2015
First Posted
January 26, 2015
Study Start
February 1, 2015
Primary Completion
May 6, 2020
Study Completion
May 6, 2020
Last Updated
February 27, 2025
Record last verified: 2025-02