Pancreatic Cancer
Conditions
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.
Detailed description
Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.
Interventions
DRUGCCX872-B
Tablets (oral administration)
Sponsors
Amgen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival | 24 weeks |
| subject incidence of Grade 3 or 4 adverse events | 24 weeks |
Countries
Netherlands, United States
Outcome results
None listed