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Adenocarcinoma of the PancreasPhase 1/2NCT03778879

Pre-operative Stereotactic Body Radiation Therapy for Pancreatic Adenocarcinoma With or Without CCX872-B

A Phase 1/2 study testing CCX872-B in people with Adenocarcinoma of the Pancreas and Pancreas Cancer, run by Alan Katz at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Standard treatment for newly diagnosed operable pancreatic cancer usually involves undergoing surgery first and then receiving chemotherapy with or without radiation therapy. However, the pancreatic cancer often comes back after this treatment. Read more about this study

Who is it for?
Ages 18 years and older
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
0 participants
Where
1 siteUnited States
Study dates
1 Aug 2019to 31 Aug 2019
Phase
Phase 1/2
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

  • Patient with pathologically proven diagnosis of adenocarcinoma of the head of the pancreas
  • CT w/ contrast or MRI of the abdomen and pelvis with contrast within 6 weeks prior to registration
  • CT chest or PET/CT within 6 weeks prior to registration
  • Clinically determined to be resectable based on NCCN Criteria 3.2017: No arterial tumor contact (celiac axis, superior mesenteric artery or common hepatic artery) and no tumor contact with the superior mesenteric vein or portal vein, or < 180 degrees contact without vein contour irregularity
  • No evidence of metastatic disease and/or non-regional lymph node metastases
  • Adequate cardiopulmonary reserves to tolerate surgery
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  • ECOG performance status 0-2
  • Adequate bone marrow function defined as follows: White blood cell> 3000cells/mm^3, Absolute neutrophil count (ANC) ≥ 1500 cells/mm3, Platelets ≥ 100,000 cells/mm3, Hemoglobin ≥ 9.0 g/dl
  • Male or female subjects, aged at least 18 years; Female subjects of childbearing potential may participate if adequate contraception is used during, and for at least the three months after study completion; Male subjects with partners of childbearing potential may participate in the study if they had a vasectomy at least 6 months prior to randomization or if adequate contraception is used during, and for at least the three months after study completion; Adequate contraception is defined as resulting in a failure rate of less than 1% per year
  • Patient must sign study specific informed consent prior to study entry
  • Anticipated life expectancy ≥ 12 weeks; -

Who cannot join

  • Prior surgical resection of any pancreatic malignancy
  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
  • Any prior systemic or radiation treatment, including investigational treatments, of the patient's pancreatic tumor.
  • Prior radiotherapy to the region of pancreatic cancer that would result in overlap of radiation therapy fields
  • Severe, active comorbidity, defined as follows:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
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  • Transmural myocardial infarction within the last 6 months
  • Clinically significant ECG abnormalities e.g. QTcF >450msec
  • Acute viral, bacterial or fungal infection requiring intravenous antibiotics at the within 4 weeks of registration
  • Known active HIV, HBV or HCV infections
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration.
  • Uncontrolled diabetes or hypertension
  • Serious psychiatric illness or altered mental status
  • Severe, uncorrectable hepatic insufficiency and/or coagulation defects due to liver failure
  • Any evidence of distant metastases (M1)
  • (ONLY applies for Group 1 patients taking CCX872-B )Taking agents known to be strong inhibitors or inducers of CYP3A4 or UGT1A1 within 2 weeks prior to 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 -

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Rochester Medical Center

    Rochester, New York, 14642

Other trials in United States

About this study

Official title: A Phase 1b Trial of Neoadjuvant Stereotactic Body Radiotherapy With or Without CCR2 Inhibitor (CCX872-B) Immunotherapy for Preoperative Treatment of Resectable Pancreatic Cancer

Standard treatment for newly diagnosed operable pancreatic cancer usually involves undergoing surgery first and then receiving chemotherapy with or without radiation therapy. However, the pancreatic cancer often comes back after this treatment. Therefore, the investigators are studying whether giving treatment prior to surgery can help decrease the risk the cancer returns.

Stereotactic Body Radiation Therapy (SBRT) is a highly focused type of radiation therapy commonly used in the treatment of pancreatic cancer. This treatment has been shown to be safe and effective for the preoperative treatment of pancreatic cancer. The purpose of this study is to determine if combining an experimental drug, CCX872-B, with SBRT continues to be safe and whether the combination treatment may be more effective at boosting the participant's immune system's ability to kill the pancreatic cancer.

Read the detailed description

The investigators have shown that preoperative SBRT followed by surgical resection is feasible and safe in patients in the previous trial UGIP14107. The investigators have also presented preclinical evidence that inhibiting entry of CCR2+ IM using a small molecule antagonist against CCR2 results in enhanced efficacy of RT 26. The investigators hypothesize that inhibition of the CCR2 axis can potentially up regulate the immune response following radiation, therefore leading to a more robust tumor killing response. In preclinical studies, CCR2 inhibitor has little effect in the absence of RT, therefore, the investigators are not including a drug therapy alone group. To test this hypothesis, a phase Ib clinical trial has been proposed to evaluate the effect of combining stereotactic body radiotherapy with CCR2 inhibition in the neoadjuvant treatment of surgically resectable adenocarcinoma of the head of the pancreas.

The study will consist of two parts in sequential fashion. The first fifteen patients will be assigned to Group 1 and undergo SBRT with CCR2 inhibitor CCX872-B. The primary objective is to establish safety and feasibility of the treatment and analyze biomarkers to determine if combined treatment can stimulate an immune response in human patients. A second group of 5 patients will undergo SBRT alone as a comparison group for biomarker immune response.

The investigators would like to proceed with SBRT and CCX872-B as Group 1 given the investigators already have sufficient data from UGIP14107 to show that SBRT is safe and feasible and studying the combination of SBRT with CCX872-B is the primary scientific objective of this study. If unexpected safety issues occur with Group 1, the investigators would consider closing trial at that time without enrolling any patients in Group 2 which would reduce the number of patients exposed to the study.

Being tested
CCX872-B
Keywords
Adenocarcinoma, Pancreas, Radiation Therapy, CCX872-B
Medical subject headings
Pancreatic Neoplasms, Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CCX872-BDrug

    CCX872-B concurrent with stereotactic body radiation therapy for pancreatic adenocarcinoma.

Study groups in NCT03778879
Study groupRoleWhat they receive
Group 1:With CCX872-BExperimentalConcurrent SBRT 25 Gy in 5 fractions over 5-7 days, and 21 days of CCX872-B therapy. CCX872-B 150 mg by mouth twice daily approximately 12 hours apart.
Receives: Drug: CCX872-B
Group 2:Without CCX872-BNo interventionSBRT Alone: 25 Gy in 5 fractions over 5-7 days

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of patients who complete radiation therapy, drug treatment and surgery

    Number of patients who proceed through radiation and drug treatment and undergo surgical resection in a timely manner.

    Measured: 6 weeks

  2. Percentage of patients who are ineligible for surgical resection due to toxicity from SBRT + CCX872-B or SBRT alone

    Assessment of whether patients are made ineligible for surgical resection solely due to toxicities from SBRT + CCX872-B or SBRT alone.

    Measure of Grade 3 toxicity directly attributable to SBRT+ CCX872-B or SBRT alone.

    Analyze rate of grade 2 or greater acute toxicity caused by SBRT with or without CCX872-B.

    Determination of intraoperative and postoperative surgical morbidity following neoadjuvant treatment including the amount of fibrosis and total operative time.

    Measured: 12 weeks

Secondary outcomes (4)

  1. Number of participants with no further growth of cancer at original site

    Count subjects with no further growth of cancer at original site

    Measured: 2 years

  2. Number of subjects with recurrence of cancer in other body sites

    Compare recurrence locations (metastases to other organs or non-regional adenopathy) of treated patients relative to historical controls

    Measured: 2 years

  3. Mean time to progression of pancreatic cancer

    Duration of progression free survival of treated patients

    Measured: 4 years

  4. Mean time to death

    Measure duration of survival of treated patients

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2018
  2. Study start1 Aug 2019 (estimated)
  3. Primary completion31 Aug 2019 (estimated)
  4. Study completion31 Aug 2019 (estimated)

Why it stopped: CCX872-B will not be available in sufficient quantity to conduct the study.

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03778879
Sponsor's protocol ID
UGIP18131
Status last verified
Jul 2019
First submitted
15 Dec 2018
Last updated
19 Jul 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CCX872-B in people with Adenocarcinoma of the Pancreas and Pancreas Cancer, run by Alan Katz at 1 site in United States.

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 11 inclusion and 16 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: withdrawn, as of the sponsor's last update on 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was withdrawn before enrolling participants, so there are no results.

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?

Percentage of patients who complete radiation therapy, drug treatment and surgery (time frame: 6 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?

On the ClinicalTrials.gov record for NCT03778879.

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 19 Jul 2019.

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