Spots Global Cancer Trial Database for Study of Eryaspase in Combination With Chemotherapy Versus Chemotherapy Alone as 2nd-Line Treatment in PAC
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Trial Identification
Brief Title: Study of Eryaspase in Combination With Chemotherapy Versus Chemotherapy Alone as 2nd-Line Treatment in PAC
Official Title: A Randomized, Phase 3 Study of Eryaspase in Combination With Chemotherapy Versus Chemotherapy Alone as 2nd-Line Treatment of Patients With Pancreatic Adenocarcinoma
Study ID: NCT03665441
Conditions
Study Description
Brief Summary: 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.
Detailed Description: Patients who meet all inclusion and exclusion criteria will be randomized in a 1:1 ratio to one of the following treatment arms (see figure below): * Arm A (investigational arm): eryaspase in combination with either gemcitabine/Abraxane or irinotecan-based therapy (FOLFIRI \[FOLinic acid-Fluorouracil-IRInotecan regimen\] or Onivyde®/5 fluorouracil/leucovorin), or * Arm B (control arm): gemcitabine/Abraxane or irinotecan-based therapy (FOLFIRI or Onivyde/5-FU/leucovorin) The chemotherapy will be investigator's choice and based on what patient has received in first line treatment. Treatment will continue until disease progression, unacceptable toxicity, or the patient's withdrawal of consent. An End of Treatment visit should occur within approximately 30 days from last dose of eryaspase or chemotherapy regimen. A survival follow-up period will include the collection of survival, progression of disease if applicable, treatment updates, and quality of life assessments every 8 weeks.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arizona Cancer Center, Scottsdale, Arizona, United States
St. Joseph Heritage Healthcare, Fullerton, California, United States
University of California Davis Medical Center, Sacramento, California, United States
Georgetown University Hospital, Washington, District of Columbia, United States
Boca Raton Regional Hospital, Boca Raton, Florida, United States
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
University of Minnesota Health Clinics and Surgery Center, Minneapolis, Minnesota, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Weill Cornell Medicine, New York, New York, United States
University of Rochester Medical Center, Rochester, New York, United States
Stony Brook University, Stony Brook, New York, United States
Duke University, Durham, North Carolina, United States
Medical Oncology Associates, Spokane, Washington, United States
Institut de Cancerologie, Brest, , France
Hammersmith Hospital, London, , United Kingdom
Contact Details
Name: Manuel Hidalgo, MD, PhD
Affiliation: Weill Cornell, NY, US
Role: PRINCIPAL_INVESTIGATOR
Name: Pascal Hammel, MD, PhD
Affiliation: Hospital Beaujon, Clichy, France
Role: PRINCIPAL_INVESTIGATOR
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