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TPS5608 : A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Assess the Efficacy and Safety of Farletuzumab (MORAb-003) in Combination with Carboplatin plus either Paclitaxel or Pegylated Liposomal Doxorubicin (PLD) in Subjects with Low CA125 Platinum-Sensitive Ovarian Cancer.

Researchers

Presenter

  • Thomas J. Herzog

Principal Investigators

  • Sharad A. Ghamande

  • Hani Gabra

  • Deborah Kay Armstrong

  • Keiichi Fujiwara

  • Bradley J. Monk

  • Sandro Pignata

  • Antonio Gonzalez-Martin

  • Jalid Sehouli

  • Charles Schweizer

  • Susan Weil

  • Kimberly Hoffman

  • Luigi Grasso

  • Robert L. Coleman

  • Ignace Vergote

Medical Centers

  • University of Cincinnati, University of Cincinnati Cancer Institute, Cincinnati, OH

  • Georgia Regents University, August, GA

  • The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins, Baltimore, MD

  • Saitama Medical University International Medical Center, Hidaka, Japan

  • University of Arizona Cancer Center at Dignity Health St. Joseph's Hospital and Medical Center, Phoenix, AZ

  • MITO and Istituto Nazionale Tumori di Napoli, Naples, Italy

  • MD Anderson Cancer Center, Madrid, Spain

  • Charite, Campus Virchow, Berlin, Germany

  • Morphotek, Inc., Exton, PA

  • Morphotek, Inc., Exton, PA

  • The University of Texas MD Anderson Cancer Canter, Houston, TX

  • Universitaire Ziekenhuizen Leuven, Leuven, Belgium

Locations

  • Japan

  • Italy

  • Spain

  • Germany

  • United Kingdom

  • United States

  • Belgium

Companies

  • N/A

Study Components

Therapeutic Area

  • Oncology (ONC)

  • Genetic Disorder

Disease

  • Gynaecological cancer

Biomarkers

  • Carbohydrate antigen 125

Drug/Treatment

  • Doxorubicin Hydrochloride

  • Farletuzumab

  • Carboplatin

  • Doxorubicin

  • Paclitaxel

Outcome

  • N/A


Study Design

  • Randomized

  • Placebo Control

  • Double Blind/Blinded

  • Controlled

Phase

  • II

Study Id's

  • NCT02289950

Sponsors

  • N/A

Result

  • N/A