Sonbol CanStem111P FON IFG - Future Medicine · Sonbol_CanStem111P_FON IFG Author: Lucy Turner...
Transcript of Sonbol CanStem111P FON IFG - Future Medicine · Sonbol_CanStem111P_FON IFG Author: Lucy Turner...
-
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