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Title of articleCanStem111P trial: A Phase 3 Study of napabucasin plus nab-paclitaxel with gemcitabine

Article details

AuthorsMohamad Sonbol, Daniel Ahn, David Goldstein, T Okusaka, Josep Tabernero, T Macarulla, M Reni, Chung-Pin Li, Bert O'Neil,Eric Van Cutsem & Tanios Bekaii-Saab

Article URLwww.futuremedicine.com/doi/10.2217/fon-2018-0903

Trial registration numberNCT02993731

Compare PFS in patients treated with napabucasin plus weekly nab-paclitaxel with gemcitabine vs. weekly nab-paclitaxel with gemcitabine alone; assess ORR – de�ned as patients with a documented (CR + PR) based on RECIST 1.1; assess quality of life, as assessed by the EORTC-QLQ-C30, in the general study population

Primary objectives/rationale

Study design and treatment including planned sample size, planned study period and study procedures

Determine whether the addition of orally administered napabucasin to weekly nab-paclitaxel and gemcitabine improves OS , compared to weekly nab-paclitaxel and gemcitabine alone in patients with mPDAC who have not received prior systemic chemotherapy in the metastatic setting

Primary objective

Secondary objectives

Global Open-label

Multicenter Phase III

Randomized patients: 1132

Randomized 1:1

?1132

Patients will be randomized in a 1:1 ratio to receive either twice daily napabucasin plus weekly nab-paclitaxel with gemcitabine (Arm A) or weekly nab-paclitaxel with gemcitabine (arm B) in 28-day cycles

Age ≥18 years

Outcome measures/end points

Secondary end points: PFS; ORR per RECIST; and QoL

Glossary

CR: Complete response; ECOg: Eastern Cooperative Oncology Group; EORTC-QLQ-C30 European Organization for Research and Treatment of Cancer Quality of Life questionnaire; OS: Overall survival; ORR: Objective response rate; mPDAC: Metastatic pancreatic adenocarcinoma; PDAC: Pancreatic adenocarcinoma; PFS: Progression-free survival; PR: Partial response; RECIST: Response Evaluation Criteria in Solid Tumors

Primary end point: OS

P3

Key eligibility criteria

Study period: December 15th 2016 – December 2020

In each arm, nab-paclitaxel at 125 mg/m2 will be administered, followed by gemcitabine 1000 mg/m2, on days 1, 8, and 15 of a 28-day cycle. In arm A, napabucasin will be given orally, twice-daily, at 240 mg (480 mg total daily dose). For cycle 1, napabucasin will be started 2–5 days prior to the �rst nab-paclitaxel with gemcitabine infusion.

Histological or cytological con�rmationof advanced PDAC that is metastatic

Patients must not have received prior cytotoxic chemotherapy or any investigational agents for treatment of mPDAC except in the case where either prior �uoropyrimidine or gemcitabine was used as a radiation sensitizer in the adjuvant setting with last dose administered > 6 months prior to randomization.

ECOG performance status score of 0 or 1 at randomization

Patients must have had adequate liver, renal and bone marrow function

18+

Study design and treatment including planned sample size, planned study period and study procedures

Treatment-naive mPDACpatients

Nab-paclitaxel +gemcitabine

Napabucasin + nab-paclitaxel+ gemcitabine

Treatment until RECIST disease progression or unacceptable

toxicity

1:1 randomization

Future Medicine Ltd