# CanStem111P

Source: https://onco.cc/trials/canstem111p/  
OnCo record `canstem111p` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

CanStem111P is the largest first-line pancreatic cancer trial ever run, 1,134 patients, and it found that the stemness inhibitor napabucasin added nothing to nab-paclitaxel and gemcitabine; the trial was stopped for futility and its control arm is now the best description of what that chemotherapy achieves.

## Summary

Between January 2017 and February 2019, 1,779 patients were screened and 1,134 randomised (565 napabucasin, 569 control), 206 and 176 of them biomarker-positive. Median overall survival was 11.4 months (95 percent confidence interval 10.5 to 12.2) with napabucasin against 11.7 months (10.7 to 12.7) with chemotherapy alone (hazard ratio 1.07, 0.93 to 1.23), with no difference in the phospho-STAT3-positive subgroup, and the trial was terminated for futility. Grade 3 or worse adverse events occurred in 85.4 against 83.9 percent, with more gastrointestinal events on napabucasin (diarrhoea 11.6 against 4.9 percent; abdominal pain 10.0 against 4.8). The 11.7-month control-arm survival, higher than MPACT's 8.5 months, reflects fitter trial populations and better supportive care a decade on, and is the yardstick against which NAPOLI 3's 9.2-month control arm is often compared.

## Fields

- Kind: Trial
- Status: negative
- Last checked: 2026-09-24
- Also known as: CanStem 111P; BBI-608 pancreatic phase 3
- Registry id: NCT02993731
- Phase: 3
- Setting: Untreated metastatic pancreatic adenocarcinoma at 165 sites in 20 countries: napabucasin with nab-paclitaxel plus gemcitabine against chemotherapy alone, open-label, adaptive, with overall survival as the primary endpoint and a phospho-STAT3 biomarker subgroup
- Sponsor: Sumitomo Pharma Oncology (Boston Biomedical)
- Enrolled: 1134
- Result: Median overall survival 11.4 months with napabucasin plus nab-paclitaxel and gemcitabine against 11.7 months with chemotherapy alone (hazard ratio 1.07, 95 percent confidence interval 0.93 to 1.23); terminated for futility.
- Outcomes: Overall survival: Napabucasin + nab-paclitaxel + gemcitabine 11.4 months vs Nab-paclitaxel + gemcitabine 11.7 months, HR 1.07

## Sources

- ClinicalTrials.gov NCT02993731: https://clinicaltrials.gov/study/NCT02993731
- Bekaii-Saab et al., CanStem111P (eClinicalMedicine 2023): https://doi.org/10.1016/j.eclinm.2023.101897

## Connected records

- cancers: [Metastatic pancreatic ductal adenocarcinoma](https://onco.cc/cancers/metastatic-pdac/), [Pancreatic ductal adenocarcinoma](https://onco.cc/cancers/pancreatic/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/)
- drugs: [Gemcitabine + nab-paclitaxel](https://onco.cc/drugs/gemcitabine-nab-paclitaxel/), [Nab-paclitaxel](https://onco.cc/drugs/nab-paclitaxel/), [Napabucasin](https://onco.cc/drugs/napabucasin/)
- companies: [Sumitomo Pharma (Myovant)](https://onco.cc/companies/sumitomo-pharma/)
- terms: [Pancreatic cancer: the failed and stopped programmes and why](https://onco.cc/terms/pancreatic-failed-programmes/)
- people: [Tanios Bekaii-Saab](https://onco.cc/people/tanios-bekaii-saab/)
- trials: [NAPOLI 3](https://onco.cc/trials/napoli-3/)

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