Study of Eryaspase in Combination With Chemotherapy Versus Chemotherapy Alone as 2nd-Line Treatment in PAC

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
ERYtech Pharma
Study ID
NCT03665441
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • eryaspase — DRUG
    L-asparaginase encapsulated in erythrocytes (red blood cells)
  • Gemcitabine plus Abraxane — DRUG
    gemcitabine, Abraxane
  • Irinotecan plus 5-FU plus leucovorin — DRUG
    irinotecan, 5-FU, leucovorin

Study Details

This is an open-label, multicenter, randomized, Phase 3 study in patients with ductal adenocarcinoma of the pancreas who have failed only one prior line of systemic anti-cancer therapy for advanced pancreatic cancer and have measurable disease.

Key Dates

Start date
Sep 15, 2018
Status verified
Jan 2021
Primary completion
Aug 30, 2021
Completion
Jan 18, 2022

Study Design

Enrollment
512 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Eryaspase plus Chemotherapy
    eryaspase 100 U/kg dosed every 2 weeks in combination with Gemcitabine plus abraxane (albumin-bound paclitaxel) administered on Days 1, 8, and 15 of each 4 week cycle as follows: * Abraxane (125 mg/m2) IV * Gemcitabine (1000 mg/m2) IV Or Irinotecan plus 5-FU plus leucovorin administered on Days 1 and 15 of each 4 week cycle as follows: * Onivyde 70 mg/m2 (irinotecan freebase) IV (recommended dose in patients homozygous for UGT1A1\*28 is 50 mg/m2) * Leucovorin 400 mg/m2 IV * 5 FU 2400 mg/m2 Or * FOLFIRI: Irinotecan 180 mg/m2 IV * Leucovorin 400 mg/m² IV * 5 FU 400 mg/m² IV bolus * 5 FU 2400 mg/m² IV continuous infusion over 46 hours immediately following bolus 5 FU
  • Other: Chemotherapy alone
    Standard treatment: Gemcitabine plus abraxane (albumin-bound paclitaxel) administered on Days 1, 8, and 15 of each 4 week cycle Or Irinotecan plus 5-FU plus leucovorin administered on Days 1 and 15 of each 4 week cycle

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: ~12 months ]

Locations (14)

FacilityCityStateZIPSite coordinators
Arizona Cancer CenterScottsdaleArizona85258-
St. Joseph Heritage HealthcareFullertonCalifornia92835-
University of California Davis Medical CenterSacramentoCalifornia95817-
Georgetown University HospitalWashington D.C.District of Columbia20057-
Boca Raton Regional HospitalBoca RatonFlorida33486-
Ochsner Clinic FoundationNew OrleansLouisiana70121-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
University of Minnesota Health Clinics and Surgery CenterMinneapolisMinnesota55455-
Roswell Park Cancer InstituteBuffaloNew York14263-
Weill Cornell MedicineNew YorkNew York10021-
University of Rochester Medical CenterRochesterNew York14642-
Stony Brook UniversityStony BrookNew York10021-
Duke UniversityDurhamNorth Carolina27705-
Medical Oncology AssociatesSpokaneWashington99208-

Find similar trials in Scottsdale, AZ

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Arizona Cancer Center· Scottsdale, AZSt. Joseph Heritage Healthcare· Fullerton, CAUniversity of California Davis Medical Center· Sacramento, CAGeorgetown University Hospital· Washington D.C., DCBoca Raton Regional Hospital· Boca Raton, FLOchsner Clinic Foundation· New Orleans, LA

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