TerminatedPhase 2

Maintenance Rucaparib in BRCA1, BRCA2 or PALB2 Mutated Pancreatic Cancer That Has Not Progressed on Platinum-based Therapy

Stopped: Loss of funding

United States46 participantsStarted 2017-09-05

Plain-language summary

The main purpose of this study is to look at the effectiveness, safety, and antitumor activity (preventing growth of the tumor) of the experimental study drug rucaparib (also known as CO-338) on subjects and on their pancreatic cancer.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Absolute neutrophil count (ANC) ≥1.5 x 109/L
✓. Platelets\>100 x 109/L
✓. Hemoglobin≥9g/dL
✓. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 x upper limit of normal (ULN)
✓. Total bilirubin ≤1.5 x ULN; if liver metastases or metabolic disorder such as Gilbert's syndrome, then ≤2.5 x ULN.
✓. Serum creatinine ≤1.5 x ULN or estimated glomerular filtration rate (GFR) ≥45 mL/min using Cockcroft Gault formula.

What they're measuring

Progression-Free Survival (PFS) at 6 Months (PFS6)

Timeframe: 6 months

Trial details

NCT IDNCT03140670

SponsorAbramson Cancer Center at Penn Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-10-29

Results submitted2023-04-18

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