alvleesklier pancreatic adenocarcinoma Pancreatic cancer
Conditions
Sponsors
Chemocentryx
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Have histologically or cytologically confirmed pancreatic adenocarcinoma.;2. Eastern Cooperative Oncology Group (ECOG) performance status score = 12 weeks.;5. Ability to provide written informed consent and comply with the requirements of the study protocol.;In part B of the study , subjects must additionally meet these entry criteria:;6. Have non-resectable pancreatic adenocarcinoma with or without metastases. ;7. Have radiographically measureable disease according to RECIST 1.1.
Exclusion criteria
Exclusion criteria: 1. Received other cancer treatment or any investigational drug within 4 weeks prior to screening.;2. Women who are pregnant or breastfeeding.;3. Had major surgery within 4 weeks of the first dose of study drug.;4. Inadequate liver, renal, or bone marrow function within 2 weeks before first dosing.;5. Serious concurrent illness, altered mental status or any uncontrolled medical condition.;6. Any infection requiring antibiotic or anti-viral treatment within 4 weeks of screening.;7. Known active HIV, HBV or HCV infection.;8. Taking agents known to be strong inhibitors or inducers of CYP3A4 or UGT1A1 within 2 weeks of Day 1 dosing; these include atazanavir, boceprevir, clarithromycin, conivaptan, gemfibrozil, grapefruit juice, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole, rifampin, and carbamazepine; use of these drugs must be avoided during the study and until 2 weeks after stopping CCX872-B treatment.;9. Taking any other test drug within 3 weeks or 5 half-lives (whichever is longer) prior to Day 1 of the study;;10. Inability to swallow tablets.;11. History or presence of any medical condition or disease which may place the subject at unacceptable risk for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint is progression-free survival, based on RECIST 1.1 when all patients have completed at least 24 weeks (Day 169) in Part B of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy endpoints: 1. Change from baseline to Day 85 (and other available time points) in the tumor density of CCR2-positive celles, myoloid cells, tumor-associated macrophages, and effector cells. 2. The tumor control rate (TCR) as defined by stable disease, partial response and complete response. 3. Overall patient survival when all patients have completed at least 24 weeks. 4. Change from baseline to Day 85 (and other available time points) in cytokine expression profile in tumor samples based on protein or gene expression changes of cytokines. | — |
Countries
Netherlands, United States of America
Outcome results
None listed