Hedgehog Inhibitors for Metastatic Adenocarcinoma of the Pancreas

Phase 2 Completed 98 enrolled Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Celgene Corporation · collab Genentech, Inc. · collab Stand Up To Cancer · collab

NaSingle-groupOpen-labelTreatment

Summary

This is an open-label, single arm, multi-center, Phase II trial to evaluate the progression free survival in patients with metastatic adenocarcinoma of the pancreas treated with a hedgehog inhibitor (GDC-0449) in combination with chemotherapy (gemcitabine and nab-Paclitaxel).

Timeline

Start: 2010-09-17
Primary completion: 2017-12-01
Completion: 2018-02-17

Outcome

Missed primary endpoint

paper Adding vismodegib to chemotherapy did not improve efficacy as compared with historical rates observed with chemotherapy alone in patients with newly diagnosed metastatic pancreatic cancer. PMID 31857726 ↗

Publications

De Jesus-Acosta A, Sugar EA, O'Dwyer PJ, Ramanathan RK, Von Hoff DD, Rasheed Z, Zheng L, Begum A, Anders R, Maitra A, McAllister F, Rajeshkumar NV, Yabuuchi S, de Wilde RF, Batukbhai B, Sahin I, Laheru DA. Phase 2 study of vismodegib, a hedgehog inhibitor, combined with gemcitabine and nab-paclitaxel in patients with untreated metastatic pancreatic adenocarcinoma. Br J Cancer. 2020 Feb;122(4):498-505. doi: 10.1038/s41416-019-0683-3. Epub 2019 Dec 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vismodegib	Small molecule	150 mg	Oral
Background	Gemcitabine	Small molecule	1000 mg/m2	—
Background	Nab-paclitaxel	Small molecule	125 mg/m2	—