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A Randomized, Double-Blind, Placebo-Controlled Phase II Study of the Efficacy and Safety of Monotherapy Ontuxizumab (MORAb-004) Plus Best Supportive Care in Patients with Chemorefractory Metastatic Colorectal Cancer.

Publication ,  Journal Article
Grothey, A; Strosberg, JR; Renfro, LA; Hurwitz, HI; Marshall, JL; Safran, H; Guarino, MJ; Kim, GP; Hecht, JR; Weil, SC; Heyburn, J; Wang, W ...
Published in: Clin Cancer Res
January 15, 2018

Purpose: The purpose of this study was to evaluate the safety and efficacy of ontuxizumab (MORAb-004), a monoclonal antibody that interferes with endosialin (tumor endothelial marker-1) function, in patients with chemorefractory metastatic colorectal cancer and to identify a responsive patient population based on biomarkers.Experimental Design: This was a randomized, double-blind, placebo-controlled, phase II study. Patients were randomly assigned in a 2:1 ratio to receive weekly intravenous ontuxizumab (8 mg/kg) or placebo plus best supportive care until progression or unacceptable toxicity. Tissue and blood biomarkers were evaluated for their ability to identify a patient population that was responsive to ontuxizumab.Results: A total of 126 patients were enrolled. No significant difference between the ontuxizumab and placebo groups was evident for the primary endpoint of progression-free survival (PFS), with a median PFS of 8.1 weeks in each group (HR, 1.13; 95% confidence interval, 0.76-1.67; P = 0.53). There were no significant differences between groups for overall survival (OS) or overall response rate (ORR). The most common treatment-emergent adverse events (TEAEs) in the ontuxizumab group (vs. the placebo group, respectively) were fatigue (53.7% vs. 47.5%), nausea (39.0% vs. 35.0%), decreased appetite (34.1% vs. 27.5%), and constipation (28.0% vs. 32.5%). The most common grade 3/4 TEAE in the ontuxizumab group versus placebo was back pain (11.0% vs. 0%). No single biomarker clearly identified patients responsive to ontuxizumab.Conclusions: No benefit with ontuxizumab monotherapy compared with placebo for clinical response parameters of PFS, OS, or ORR was demonstrated. Ontuxizumab was well tolerated. Clin Cancer Res; 24(2); 316-25. ©2017 AACR.

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Published In

Clin Cancer Res

DOI

EISSN

1557-3265

Publication Date

January 15, 2018

Volume

24

Issue

2

Start / End Page

316 / 325

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Palliative Care
  • Oncology & Carcinogenesis
  • Odds Ratio
  • Neoplasm Staging
  • Neoplasm Metastasis
  • Middle Aged
  • Male
  • Kaplan-Meier Estimate
  • Humans
 

Citation

APA
Chicago
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Grothey, A., Strosberg, J. R., Renfro, L. A., Hurwitz, H. I., Marshall, J. L., Safran, H., … Diaz, L. A. (2018). A Randomized, Double-Blind, Placebo-Controlled Phase II Study of the Efficacy and Safety of Monotherapy Ontuxizumab (MORAb-004) Plus Best Supportive Care in Patients with Chemorefractory Metastatic Colorectal Cancer. Clin Cancer Res, 24(2), 316–325. https://doi.org/10.1158/1078-0432.CCR-17-1558
Grothey, Axel, Jonathan R. Strosberg, Lindsay A. Renfro, Herbert I. Hurwitz, John L. Marshall, Howard Safran, Michael J. Guarino, et al. “A Randomized, Double-Blind, Placebo-Controlled Phase II Study of the Efficacy and Safety of Monotherapy Ontuxizumab (MORAb-004) Plus Best Supportive Care in Patients with Chemorefractory Metastatic Colorectal Cancer.Clin Cancer Res 24, no. 2 (January 15, 2018): 316–25. https://doi.org/10.1158/1078-0432.CCR-17-1558.
Grothey A, Strosberg JR, Renfro LA, Hurwitz HI, Marshall JL, Safran H, Guarino MJ, Kim GP, Hecht JR, Weil SC, Heyburn J, Wang W, Schweizer C, O’Shannessy DJ, Diaz LA. A Randomized, Double-Blind, Placebo-Controlled Phase II Study of the Efficacy and Safety of Monotherapy Ontuxizumab (MORAb-004) Plus Best Supportive Care in Patients with Chemorefractory Metastatic Colorectal Cancer. Clin Cancer Res. 2018 Jan 15;24(2):316–325.

Published In

Clin Cancer Res

DOI

EISSN

1557-3265

Publication Date

January 15, 2018

Volume

24

Issue

2

Start / End Page

316 / 325

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Palliative Care
  • Oncology & Carcinogenesis
  • Odds Ratio
  • Neoplasm Staging
  • Neoplasm Metastasis
  • Middle Aged
  • Male
  • Kaplan-Meier Estimate
  • Humans