TerminatedPhase 2

TAS-102 (Lonsurf) in Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma Post First Line Chemotherapy (UF-STO-PANC-003)

Stopped: insufficient time to accrue sufficient subjects before end of funding

United States7 participantsStarted 2017-11-09

Plain-language summary

This is an open-label, non-randomized, sequentially enrolling single arm phase II trial to evaluate the activity of TAS-102 in previously treated metastatic and locally advanced unresectable pancreatic cancer after progression through or intolerance to first or second line chemotherapy. Trial therapy will consist of TAS-102 (Lonsurf®) 35 mg/m2 to be given orally twice daily on days 1-5 and 8-12 with cycles repeating every 28 days. The primary endpoint is to determine the progression free survival (PFS) in subjects with unresectable pancreatic adenocarcinoma.

Who can participate

Age range18 Years – 90 Years

SexALL

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Inclusion criteria

✓. Absolute neutrophil count \>1500/mm3
✓. Platelet count \>75,000/mm3
✓. HGB equal to or greater than 7g/dL
✓. Total bilirubin ≤ 1.5 mg/dL
✓. AST and ALT equal to or less than 3 times the upper limit of normal for patients without hepatic involvement, or AST and ALT equal to or less than 5 times the upper limit of normal for patients with hepatic involvement
✓. Serum calcium ≤ 12 mg/dl

What they're measuring

Progression Free Survival (PFS)

Timeframe: up to 54 weeks

Trial details

NCT IDNCT02921737

SponsorUniversity of Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-07-26

Results submitted2020-12-15

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