Plerixafor for Pancreatic Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Pancreatic CancerPlerixafor - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer treatment combination for safety and effectiveness in people with pancreatic cancer that has spread.

Eligible Conditions
  • Pancreatic Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 4 years

4 years
Number of participants experiencing grade 3 or above drug-related toxicities
Objective response rate (ORR) using immune RECIST (iRECIST) criteria
Overall Response Rate (ORR) using RECIST 1.1 criteria

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Filgrastim (Neupogen) and Plerixafor
43%Bone pain
41%Lymphocyte count decreased
39%Platelet count decreased
35%Anemia
24%Alkaline phosphatase increased
20%Leukocytosis
20%Lymphocyte count increased
16%Nausea
12%Diarrhea
12%Arthralgia
10%Dizziness
10%Chills
8%Activated partial thromboplastin time prolonged
8%Back pain
8%Hypoalbuminemia
8%Edema - limbs
8%Bleeding at catheter site
8%Headache
8%Paresthesia
8%Vomiting
8%Dyspnea
8%INR increased
6%Hyperuricemia
6%Fatigue
6%Constipation
6%Abdominal pain
6%White blood cell decreased
6%Anxiety
4%Injection site reaction
4%Non-cardiac chest pain
4%Hypercalcemia
4%Hypocalcemia
4%Hypokalemia
4%Pain in extremity
4%Hypertension
4%Hypotension
4%Fever
4%Hypophosphatemia
4%Peripheral sensory neuropathy
2%Febrile neutropenia
2%Hypohidrosis
2%Weight loss
2%Scleral disorder
2%Rhinovirus positive culture
2%Cellulitis
2%Aspartate aminotransferase increased
2%Creatinine increased
2%Neutrophil count decreased
2%Hypomagnesemia
2%Hyperglycemia
2%Hand cramping
2%Proteinuria
2%Confusion
2%Rash maculo-papular
2%Drainage at catheter
2%Pain
2%Alanine aminotransferase increased
2%Central line site cellulitis
2%Oral dysesthesia
2%Blood bilirubin increased
2%Anorexia
2%Joint range of motion decreased
2%Neck pain
2%Numbness of face
2%Productive cough
2%Pruritus
2%Hyponatremia
This histogram enumerates side effects from a completed 2016 Phase 2 trial (NCT02098109) in the Filgrastim (Neupogen) and Plerixafor ARM group. Side effects include: Bone pain with 43%, Lymphocyte count decreased with 41%, Platelet count decreased with 39%, Anemia with 35%, Alkaline phosphatase increased with 24%.

Trial Design

1 Treatment Group

Cemiplimab and Plerixafor
1 of 1

Experimental Treatment

21 Total Participants · 1 Treatment Group

Primary Treatment: Plerixafor · No Placebo Group · Phase 2

Cemiplimab and PlerixaforExperimental Group · 2 Interventions: Cemiplimab, Plerixafor · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab
FDA approved
Plerixafor
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 4 years

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,071 Previous Clinical Trials
41,128,834 Total Patients Enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
536 Previous Clinical Trials
31,273 Total Patients Enrolled
Genzyme, a Sanofi CompanyIndustry Sponsor
521 Previous Clinical Trials
85,423 Total Patients Enrolled
American Association for Cancer ResearchOTHER
8 Previous Clinical Trials
873 Total Patients Enrolled
Dung Le, MDPrincipal InvestigatorJohns Hopkins Medical Institution
12 Previous Clinical Trials
707 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The patients had documented radiographic disease progression after previous systemic chemotherapy given in a neoadjuvant, adjuvant, locally advanced or metastatic setting.
Any woman who could possibly become pregnant must have a negative pregnancy test and follow the guidelines for contraception as set out by the protocol.
You have metastatic disease.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 is a measure of a person's ability to work or carry out normal activities.
Have cancer that affects the ducts of the pancreas.
Patients who have a measurable lesion.
I'm willing to have a tumor biopsy.
The life expectancy of the patient is greater than three months.
Participants in the study must have normal organ and marrow function as determined by the study's specific laboratory tests.