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Study of SBP-101 Combined With Nab-Paclitaxel and Gemcitabine in Pancreatic Cancer

Stage IV Pancreatic Cancer Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03412799
Study type Interventional
Source Panbela Therapeutics, Inc.
Contact
Status Completed
Phase Phase 1
Start date June 4, 2018
Completion date February 28, 2022
View Details
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