An open-label phase 1b study to evaluate the safety and efficacy of CCX872-B in patients with pancreatic adenocarcinoma.

Completed

Conditions: alvleesklier
pancreatic adenocarcinoma
Pancreatic cancer

Registration Number: NL-OMON42021

Lead Sponsor: Chemocentryx

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 29

Inclusion Criteria

1. Have histologically or cytologically confirmed pancreatic adenocarcinoma.;2. Eastern Cooperative Oncology Group (ECOG) performance status score <= 2.;3. Male or female subjects, aged at least 18 years; Female subjects of childbearing potential and male subjects with female partners of childbearing potential using adequate contraception. See also page 37 of the protocol.;4. Anticipated life expectancy >= 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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary efficacy endpoint is progression-free survival, based on RECIST 1.1<br /><br>when all patients have completed at least 24 weeks (Day 169) in Part B of the<br /><br>study.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary efficacy endpoints:<br /><br>1. Change from baseline to Day 85 (and other available time points) in the<br /><br>tumor density of CCR2-positive celles, myoloid cells, tumor-associated<br /><br>macrophages, and effector cells.<br /><br>2. The tumor control rate (TCR) as defined by stable disease, partial response<br /><br>and complete response.<br /><br>3. Overall patient survival when all patients have completed at least 24 weeks.<br /><br>4. Change from baseline to Day 85 (and other available time points) in cytokine<br /><br>expression profile in tumor samples based on protein or gene expression changes<br /><br>of cytokines.</p><br>