Spots Global Cancer Trial Database for Study of SBP-101 in Pancreatic Cancer
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Trial Identification
Brief Title: Study of SBP-101 in Pancreatic Cancer
Official Title: A Phase 1A/1B Study of SBP-101 in Previously Treated Subjects With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma
Study ID: NCT02657330
Interventions
Study Description
Brief Summary: This phase 1 first-in-human study evaluates safety and tolerability of SBP-101 in subjects with previously treated pancreatic ductal adenocarcinoma and will identify the maximum tolerated dose (MTD). In addition, this study will also assess the pharmacokinetic (PK) profile and preliminary efficacy of SBP-101.
Detailed Description: This first-in-human study of SBP-101 will be conducted in two phases: dose escalation and expansion. The dose escalation phase of the study is to evaluate the safety, tolerability and PK profile of SBP-101 in subjects with previously treated locally advanced or metastatic pancreatic ductal adenocarcinoma. Up to 48 subjects may be enrolled in dose escalation. The expansion phase of the study will consist of 24 additional subjects who will receive the maximum tolerated dose of SBP-101 based on data from the dose escalation phase of the study.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
HonorHealth Research Institute, Scottsdale, Arizona, United States
Mayo Clinic, Scottsdale, Arizona, United States
Ashford Cancer Centre, Kurralta Park, South Australia, Australia
Austin Hospital, Heidelberg, Victoria, Australia
Contact Details
Name: Suzanne Gagnon, MD
Affiliation: Panbela Therapeutics, Inc.
Role: STUDY_DIRECTOR
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