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Pilot trial of CRLX101 in patients with advanced, chemotherapy-refractory gastroesophageal cancer

Chao, Joseph and Lin, James and Frankel, Paul and Clark, Andrew J. and Wiley, Devin T. and Garmey, Edward and Fakih, Marwan and Lim, Dean and Chung, Vincent and Luevanos, Eloise and Eliasof, Scott and Davis, Mark E. and Yen, Yun (2017) Pilot trial of CRLX101 in patients with advanced, chemotherapy-refractory gastroesophageal cancer. Journal of Gastrointestinal Oncology, 8 (6). pp. 962-969. ISSN 2078-6891. PMCID PMC5750185. doi:10.21037/jgo.2017.08.10.

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Background: CRLX101 is an investigational nanoparticle-drug conjugate with a camptothecin payload. Preclinical evidence indicated preferential uptake in tumors, and tumor xenograft models demonstrate superiority of CRLX101 over irinotecan. A pilot trial was conducted at recommended phase 2 dosing (RP2D) using the bimonthly schedule to assess preferential uptake of CRLX101 in tumor vs. adjacent normal tissue in endoscopically accessible tumors in chemotherapy-refractory gastroesophageal cancer. Results from the biopsies were previously reported and herein we present the clinical outcomes. Methods: Patients initiated CRLX101 dosed at RP2D (15 mg/m^2) on days 1 and 15 of a 28-day cycle. Detection of preferential CRLX101 tumor uptake was the primary endpoint and objective response rate (ORR) was a secondary endpoint. With a sample size of ten patients, the study had 90% power to detect ≥1 responder if the true response rate is ≥21%. Results: Between Dec. 2012 and Dec. 2014, ten patients with chemotherapy-refractory (median 2 prior lines of therapy, range 1–4) gastric adenocarcinoma were enrolled. The median time-to-progression was 1.7 months. Best response was seen in one patient with stable disease (SD) for 8 cycles. Only ≥ grade 3 drug-related toxicity occurred in one patient with grade 3 cardiac chest pain who was able to resume therapy after CRLX101 was reduced to 12 mg/m^2. Conclusions: Bimonthly CRLX101 demonstrated minimal activity with SD as best response in this heavily pretreated population. Future efforts with CRLX101 in gastric cancer should focus on combination and more dose-intensive strategies given its favorable toxicity profile and evidence of preferential tumor uptake.

Item Type:Article
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URLURL TypeDescription CentralArticle
Davis, Mark E.0000-0001-8294-1477
Yen, Yun0000-0003-0815-412X
Additional Information:© 2017 Society for Gastrointestinal Oncology. Submitted Jun 14, 2017. Accepted for publication Aug 08, 2017. We thank all the participating patients and families and the research support staff involved in carrying out this study. This study was supported by Cerulean Pharma Inc., as well as National Cancer Institute Grant L30 CA179788-01 and National Institutes of Health Grant 5K12CA001727-22. Research reported in this publication included work performed in the Biostatistics Core supported by the National Cancer Institute of the National Institutes of Health under award number P30CA033572. Conflicts of Interest: E Garmey and S Eliasof are current or former employees of Cerulean Pharma Inc. ME Davis is a consultant for Cerulean Pharma Inc. and owns stock in the company. The remaining authors have no conflicts of interest to declare. Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Funding AgencyGrant Number
Cerulean Pharma Inc.UNSPECIFIED
NIHL30 CA179788-01
National Cancer InstituteUNSPECIFIED
Subject Keywords:CRLX101; gastric cancer; esophageal cancer; clinical trial
Issue or Number:6
PubMed Central ID:PMC5750185
Record Number:CaltechAUTHORS:20180109-074115196
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Official Citation:Chao J, Lin J, Frankel P, Clark AJ, Wiley DT, Garmey E, Fakih M, Lim D, Chung V, Luevanos E, Eliasof S, Davis ME, Yen Y. Pilot trial of CRLX101 in patients with advanced, chemotherapy-refractory gastroesophageal cancer. J Gastrointest Oncol 2017;8(6):962-969. doi: 10.21037/jgo.2017.08.10
Usage Policy:No commercial reproduction, distribution, display or performance rights in this work are provided.
ID Code:84180
Deposited By: Tony Diaz
Deposited On:09 Jan 2018 16:01
Last Modified:15 Nov 2021 20:17

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