The study will be conducted in two parts, Part A and Part B. The main purpose of Part A of the study is to evaluate the safety and tolerability, the blood levels and the extent of receptor blockade of CCX872-B in patients with pancreatic cancer. In…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
alvleesklier
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
CCX872-B is an investigational medication for the treatment of patients with
pancreatic cancer. It works by blocking the infiltration of cells of the immune
system into the tumor that are thought to block the part of your immune system
that can fight the cancer cells.
An investigational medication is a medication or a formulation of a medication
that is still being studied. It has not been approved by the US Food and Drug
Administration, the European Medicines Agency or any of the Regulatory
authorities in the European countries.
This investigational medication is being developed by ChemoCentryx, Inc., which
is the Sponsor of this study and pays for the study.
Study objective
The study will be conducted in two parts, Part A and Part B. The main purpose
of Part A of the study is to evaluate the safety and tolerability, the blood
levels and the extent of receptor blockade of CCX872-B in patients with
pancreatic cancer. In this part of the study (Part A), the efficacy will not be
evaluated.
CCX872-B is provided in a tablet form and will be taken by mouth. In Part A,
subjects will receive a single dose of CCX872-B.
Part B of the study will only start after the results of Part A were analyzed
and after, based on these results, it was concluded that it is safe and
appropriate to proceed. The purpose of Part B is to determine whether the
investigational medication CCX872-B is safe in patients with pancreatic cancer
who also receive standard FOLFIRINOX chemotherapy, when administered over a
period of at least 12 weeks, and whether it slows down the progression of the
disease.
Subjects who participate in Part A may be eligible for Part B, if they are
candidates for FOLFIRINOX chemotherapy.
Study design
Part A: This part of the study consists of a single dose of treatment with
CCX872-B followed by a 7-day follow-up period.
You will be asked to take the dose of study medication while you are at the
study center, in the presence of the study staff.
Part B: You will receive CCX872-B 150 mg once or twice daily starting on Day 1
and will continue dosing for at least 12 weeks (84 days). The study visits
during this 12-week treatment period are Days 1, 8, 15, 29, 43, 57, 71, and 85,
with a 4-week follow-up period after end of treatment (Day 113).
If you show at least stable disease according to a validated tumor evaluation
method (called RECIST 1.1) at the end of the 12-week period (Day 85), you are
eligible for continuation of CCX872-B treatment until disease progression or
until you experience unacceptable toxicity.
In this case and if you agree to continue CCX872-B treatment beyond Day 85, you
will need to continue to visit the study center at Day 1 and 15 of each 28-day
cycle.
In Part B you will receive your first regimen of FOLFIRINOX chemotherapy on
Study Day 1.
The FOLFIRINOX chemotherapy is for treatment of pancreatic cancer and is not
investigational (not experimental). It consists of oxaliplatin 85 mg/m2 IV,
irinotecan 180 mg/m2 IV, leucovorin 400 mg/m2 IV, and 5-FU 400 mg/m2 bolus,
followed by 2400 mg/m2 by central IV infusion over 46 hours starting on Day 1.
The FOLFIRINOX chemotherapy will be repeated every 2 weeks for up to 12 cycles.
Intervention
Not applicable.
Study burden and risks
CCX872-B has been evaluated in healthy subjects. The most common side effect
reported after a single dose in this study was headache in 7% of subjects. The
most common side effects reported after multiple daily doses in this study were
diarrhea (13%), stuffy nose (13%), dizziness (13%) and headache (10%). No
hospitalizations due to side effects occurred in this study.
It is possible that unforeseen adverse events may occur. The patient will be
monitored carefully during the study for any adverse effects.
During the collection of blood samples, the patient may experience pain and/or
bruising at the insertion site of the needle/indwelling cannula. Although rare,
localized clot formation and infections at the injection site may occur.
Lightheadedness and/or fainting may also occur during or shortly after the
blood draw.
ECG patches may cause a skin reaction such as redness or itching. The patient
may also experience localized skin discomforts and/or hair loss associated with
the placement of ECG leads.
Additional risks for participants in Part B:
FOLFIRINOX may cause low red blood cell counts, low platelet counts, low white
blood cell counts, tiredness, vomiting, diarrhea , nervous system toxicity,
elevated liver enzymes, and blood clots.
Maude Avenue 850
Mountain View CA 94043
US
Maude Avenue 850
Mountain View CA 94043
US
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-004406-15-NL |
| CCMO | NL51406.078.15 |