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Peer-reviewedCC BY-NC-NDClinical colorectal cancer

A Phase I Study of Nab-Paclitaxel, Gemcitabine and AZD1775 for Treatment of Metastatic Adenocarcinoma of the Pancreas: ECOG-ACRIN EA2131

  • Jennifer R. Eads1
  • Ju-Whei Lee2
  • Cheng E. Chee3
  • Neal J. Meropol4,5
  • Al B. Benson6
  • Paul Catalano2
  • Efrat Dotan7,8
  • Dana B. Cardin9
  • Peter J. O’Dwyer1
9 affiliations
  1. 1University of Pennsylvania, Abramson Cancer Center, 3400 Civic Center Blvd, South Pavilion 10 Floor, Philadelphia, PA, 19104, USA.
  2. 2Dana-Farber Cancer Institute, Department of Data Science, 450 Brookline Ave, Boston, MA, 02215, USA.
  3. 3National University Cancer Institute, Singapore, National University Health System, Singapore.
  4. 4Case Western Reserve University, Case Comprehensive Cancer Center, 2103 Cornell Road, Cleveland, OH, 44106, USA
  5. 5Current Affiliation: Neal Meropol, LLC, USA.
  6. 6Northwestern University, 541 N. Fairbanks Ct, Suite 2300, Chicago, IL, 60611, USA.
  7. 7Fox Chase Cancer Center, 333 Cottman Avenue, Philadelphia, PA, 19111, USA
  8. 8Current Affiliation: Penn Medicine, Ann B. Barshinger Cancer Center, Lancaster General Health, 2102 Harrisburg Pike, Lancaster, PA.
  9. 9Vanderbilt-Ingram Cancer Center, 2220 Pierce Ave, Nashville, TN, USA.
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Abstract

PURPOSE: Pancreatic adenocarcinoma is a devastating disease for which there are limited treatment options. Identification of novel agents to enhance the activity of existing regimens is much needed. We hypothesized that the disruption of the DNA damage response by AZD1775, an oral Wee1 inhibitor, added to the nab-paclitaxel and gemcitabine chemotherapy backbone would be safe and effective. METHODS: A phase I trial to evaluate the dose-limiting toxicities and maximum tolerated dose of AZD1775 in combination with nab-paclitaxel and gemcitabine was conducted in patients with metastatic or locally advanced, unresectable pancreatic adenocarcinoma (NCT02194829). A total of 7 patients received nab-paclitaxel and gemcitabine intravenously on days 1, 8, and 15 of a 28-day treatment cycle, along with AZD1775 by mouth on days 1, 2, 8, 9, 15, and 16. Toxicities were assessed using CTCAE version 4 criteria. RESULTS: Two patients were treated at the initial dose level of nab-paclitaxel, gemcitabine, and AZD1775, and both experienced dose-limiting toxicities (dehydration, elevated bilirubin, oral mucositis, increased AST, and Candida intertrigo). Under a revised study design, 5 patients were treated, and 2 of them also developed dose-limiting toxicities (anemia, thrombocytopenia, neutropenia, hyponatremia, and febrile neutropenia). Progression-free survival (PFS) and overall survival (OS) among these 7 patients were 5.26 months (95% confidence interval [CI] [2.73, 12.16]) and 5.29 months (95% CI [2.73, 20.17]), respectively. CONCLUSION: The combination of nab-paclitaxel, gemcitabine, and AZD1775 was determined to be too toxic when administered in patients with metastatic or locally advanced, unresectable pancreatic adenocarcinoma.

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Cite

BibTeXRIS
BibTeX
@article{eads2026phase,
  title = {{A Phase I Study of Nab-Paclitaxel, Gemcitabine and AZD1775 for Treatment of Metastatic Adenocarcinoma of the Pancreas: ECOG-ACRIN EA2131}},
  author = {Jennifer R. Eads and Ju-Whei Lee and Cheng E. Chee and Neal J. Meropol and Al B. Benson and Paul Catalano and Efrat Dotan and Dana B. Cardin and Peter J. O’Dwyer},
  journal = {Clinical colorectal cancer},
  year = {2026},
  month = sep,
  doi = {10.1016/j.clcc.2026.08.004},
  url = {https://doi.org/10.1016/j.clcc.2026.08.004},
  note = {CC BY-NC-ND},
}
RIS
TY  - JOUR
TI  - A Phase I Study of Nab-Paclitaxel, Gemcitabine and AZD1775 for Treatment of Metastatic Adenocarcinoma of the Pancreas: ECOG-ACRIN EA2131
AU  - Jennifer R. Eads
AU  - Ju-Whei Lee
AU  - Cheng E. Chee
AU  - Neal J. Meropol
AU  - Al B. Benson
AU  - Paul Catalano
AU  - Efrat Dotan
AU  - Dana B. Cardin
AU  - Peter J. O’Dwyer
PY  - 2026
DA  - 2026/09/02
JO  - Clinical colorectal cancer
DO  - 10.1016/j.clcc.2026.08.004
UR  - https://doi.org/10.1016/j.clcc.2026.08.004
AB  - PURPOSE: Pancreatic adenocarcinoma is a devastating disease for which there are limited treatment options. Identification of novel agents to enhance the activity of existing regimens is much needed. We hypothesized that the disruption of the DNA damage response by AZD1775, an oral Wee1 inhibitor, added to the nab-paclitaxel and gemcitabine chemotherapy backbone would be safe and effective. METHODS: A phase I trial to evaluate the dose-limiting toxicities and maximum tolerated dose of AZD1775 in combination with nab-paclitaxel and gemcitabine was conducted in patients with metastatic or locally advanced, unresectable pancreatic adenocarcinoma (NCT02194829). A total of 7 patients received nab-paclitaxel and gemcitabine intravenously on days 1, 8, and 15 of a 28-day treatment cycle, along with AZD1775 by mouth on days 1, 2, 8, 9, 15, and 16. Toxicities were assessed using CTCAE version 4 criteria. RESULTS: Two patients were treated at the initial dose level of nab-paclitaxel, gemcitabine, and AZD1775, and both experienced dose-limiting toxicities (dehydration, elevated bilirubin, oral mucositis, increased AST, and Candida intertrigo). Under a revised study design, 5 patients were treated, and 2 of them also developed dose-limiting toxicities (anemia, thrombocytopenia, neutropenia, hyponatremia, and febrile neutropenia). Progression-free survival (PFS) and overall survival (OS) among these 7 patients were 5.26 months (95% confidence interval [CI] [2.73, 12.16]) and 5.29 months (95% CI [2.73, 20.17]), respectively. CONCLUSION: The combination of nab-paclitaxel, gemcitabine, and AZD1775 was determined to be too toxic when administered in patients with metastatic or locally advanced, unresectable pancreatic adenocarcinoma.
SN  - 1533-0028
SN  - 1938-0674
ER  -