Pancreatic CancerPhase 1NCT02345408
Phase 1b Study of CCX872-B in Patients With Pancreatic Adenocarcinoma
A Phase 1 study testing CCX872-B in people with Pancreatic Cancer, run by Amgen at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- CCX872-B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Feb 2015to 6 May 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Netherlands4 sites
Study site
Amsterdam
Study site
Nijmegen
Netherland
Rotterdam
Study site
Sittard
United States2 sites
Study site
Rochester, New York
Study site
St Louis, Missouri
About this study
Official title: An Open-label Phase 1b Study to Evaluate the Safety and Efficacy of CCX872-B in Patients With Pancreatic Adenocarcinoma
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.
Read the detailed description
Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.
- Conditions
- Pancreatic Cancer
- Being tested
- CCX872-B
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCX872-BDrug
Tablets (oral administration)
| Study group | Role | What they receive |
|---|---|---|
| CCX872-B | Experimental | 150 mg once or twice daily given orally for at least 12 weeks Receives: Drug: CCX872-B |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
Measured: 24 weeks
subject incidence of Grade 3 or 4 adverse events
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completion6 May 2020
- Study completion6 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02345408
- Sponsor's protocol ID
- CL002_872
- Status last verified
- Feb 2025
- First submitted
- 20 Jan 2015
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Phase 1b Study to Evaluate the Safety and Efficacy of CCX872-B in Patients With Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT02345408
- Acronym / sponsor ID
- CL002_872
- Conditions
- Pancreatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- 6 May 2020 (actual)
- Study completion
- 6 May 2020 (actual)
- First posted
- 26 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CCX872-B | Experimental | Drug: CCX872-B150 mg once or twice daily given orally for at least 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CCX872-BTablets (oral administration) | Drug | CCX872-B |
Primary outcome
progression-free survival
Time frame: 24 weeks
subject incidence of Grade 3 or 4 adverse events
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CCX872-B in people with Pancreatic Cancer, run by Amgen at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.