Spots Global Cancer Trial Database for Study of SBP-101 Combined With Nab-Paclitaxel and Gemcitabine in Pancreatic Cancer
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Trial Identification
Brief Title: Study of SBP-101 Combined With Nab-Paclitaxel and Gemcitabine in Pancreatic Cancer
Official Title: Phase 1A/1B Dose Escalation and Expansion Study of SBP-101 in Combination With Nab-Paclitaxel and Gemcitabine in Subjects With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma
Study ID: NCT03412799
Study Description
Brief Summary: This is an open-label phase 1A/1B study to assess the safety, tolerability and pharmacokinetics of SBP-101 when combined with nab-paclitaxel and gemcitabine in subjects with previously untreated metastatic pancreatic ductal adenocarcinoma and to identify a recommended phase 2 dose. The study will also assess preliminary efficacy of the 3-drug treatment combination.
Detailed Description: The study will be conducted in two phases: dose escalation and expansion. Up to three dose levels of SBP-101 will be assessed in up to 18 subjects during dose escalation. The expansion phase of the study will consist of 10 additional subjects who will receive the recommended dose of SBP-101 combined with nab-paclitaxel and gemcitabine.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Scripps MD Anderson Cancer Center, La Jolla, California, United States
University of Florida, Gainesville, Florida, United States
University of Rochester Medical Center, Rochester, New York, United States
Blacktown Cancer & Haematology Centre, Blacktown, New South Wales, Australia
John Flynn Private Hospital, Tugun, Queensland, Australia
Ashford Cancer Centre, Kurralta Park, South Australia, Australia
Austin Health, Heidelberg, Victoria, Australia
Contact Details
Name: Suzanne Gagnon, MD
Affiliation: Panbela Therapeutics, Inc.
Role: STUDY_DIRECTOR
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