CompletedPhase 1

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

United States, Australia50 participantsStarted 2018-06-04

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Absolute neutrophil count ≥1.5 x 109/L
✓. Hemoglobin ≥9.0 g/dL (90 g/L)
✓. Platelets ≥100 x 109/L
✓. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x upper limit of normal (ULN) (if no hepatic metastases). If hepatic tumor involvement, AST and ALT ≤5 x ULN.
✓. Bilirubin ≤1.5 x ULN
✓. Prothrombin time (PT) / international normalized ratio (INR) ≤1.5 x ULN if not on anti-coagulants
✓. Calculated creatinine clearance \>50 mL/min using the Cockcroft and Gault equation

What they're measuring

Recommended dose of SBP-101

Timeframe: Up to 12 months following the first dose of treatment

Trial details

NCT IDNCT03412799

SponsorPanbela Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-02-28

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