Thorough ECG (Electrocardiogram) and Drug Interaction Study With Anetumab Ravtansine and Itraconazole

Last updated: July 29, 2020
Sponsor: Bayer
Overall Status: Completed

Phase

1

Condition

Neoplasms

Treatment

N/A

Clinical Study ID

NCT02824042
18329
2017-001978-42
  • Ages > 18
  • All Genders

Study Summary

Characterize the safety, tolerability, ECG effects, pharmacokinetics and immunogenicity of anetumab ravtansine given as single agent and after inhibition of CYP3A4 and P-gp by concomitant administration of itraconazole in subjects with mesothelin-expressing advanced solid cancers

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects must have histologically confirmed, locally advanced or metastatic solidcancers of the following histological types:
  1. predominantly epithelial (≥50% tumor component) pleural or peritonealmesothelioma

  2. epithelial ovarian cancer (fallopian tube and primary peritoneal cancers areeligible)

  3. adenocarcinoma of the pancreas,

  4. triple-negative adenocarcinoma of the breast

  5. non-small-cell adenocarcinoma of the lung

  6. gastric cancer (including gastro-esophageal junction)

  7. colon cancer

  8. cholangiocarcinoma

  9. Thymic carcinoma

  • Subjects must have no standard therapy available, or have actively refused standardtherapy

  • Subjects must provide samples of archival tumor tissue collected and submitted anytimeduring the study

  • Subjects must have a life expectancy of at least 12 weeks

  • Subjects must have ECOG (Eastern Cooperative Oncology Group) performance status of 0or 1

  • Subjects must have adequate bone marrow, renal and hepatic function and coagulation

  • Subjects must have normal or clinically insignificant ECG at screening

  • Women of reproductive potential must have a negative serum pregnancy test obtainedwithin 3 days before the start of anetumab ravtansine

  • Women of childbearing potential and fertile men must agree to use adequatecontraception when sexually active. This applies from the time period between signingof the informed consent until at least 6 months after the last administration of thelast study drug. Male patients with a female partner of childbearing potential mustuse a condom and ensure that an additional form of contraception is also used duringtreatment and until 6 months after last study drug administration.

Exclusion

Exclusion Criteria:

  • Previous or concurrent cancer that is distinct in primary site or histology from thecancer being evaluated in this study, except cervical carcinoma in situ, treated basalcell carcinoma, superficial noninvasive bladder tumors or any previous cancercuratively treated ≥ 3 years before the start of anetumab ravtansine

  • New or progressive brain or meningeal or spinal metastases

  • Corneal epitheliopathy or any eye disorder that may predispose the subjects todrug-induced corneal epitheliopathy, or may interfere with diagnosis oftreatment-emergent corneal epitheliopathy at the ophthalmologist's or theinvestigator's discretion

  • History or current evidence of

  • biliary cirrhosis

  • malignant biliary obstruction unless the bile flow to the gastrointestinal tractis maintained by a fully operational biliary stent

  • CTCAE (Common Terminology Criteria for Adverse Events) Grade ≥2 bleeding disorderwithin 4 weeks before the start of anetumab ravtansine

  • uncontrolled cardiovascular disease or uncontrolled hypertension

  • Long QT Syndrome

  • HIV infection

  • Hepatitis B or C infection

  • Had a major surgery or significant trauma within 4 weeks before the start of anetumabravtansine

  • Had solid organ or bone marrow transplantation

  • Have LVEF (left ventricular ejection fraction) <50% at screening

  • Have QTc >450 ms or heart rate ≥100 bpm or ≤45 bpm at screening

  • Poor CYP2D6 metabolizers based on the screening test for genetic polymorphisms inCYP2D6 metabolizing capacity

Study Design

Total Participants: 63
Study Start date:
September 07, 2016
Estimated Completion Date:
August 05, 2019

Connect with a study center

  • Blacktown Cancer & Haematology Centre

    Blacktown, New South Wales 2148
    Australia

    Site Not Available

  • Epworth HealthCare

    Richmond, Victoria 3122
    Australia

    Site Not Available

  • CU Saint-Luc/UZ St-Luc

    Bruxelles - Brussel, 1200
    Belgium

    Site Not Available

  • UZ Gent

    Gent, 9000
    Belgium

    Site Not Available

  • UZ Leuven Gasthuisberg

    Leuven, 3000
    Belgium

    Site Not Available

  • Hôpital Henri Mondor

    Creteil, 94010
    France

    Site Not Available

  • Centre Georges Francois Leclerc Dijon

    Dijon, 21079
    France

    Site Not Available

  • Hôpital de la Timone - Marseille

    Marseille, 13005
    France

    Site Not Available

  • Nederlands Kanker Instituut

    Amsterdam, 1066 CX
    Netherlands

    Site Not Available

  • VUmc

    Amsterdam, 1081 HV
    Netherlands

    Site Not Available

  • Universitair Medisch Centrum St. Radboud

    Nijmegen, 6525 GA
    Netherlands

    Site Not Available

  • Ciutat Sanitària i Universitaria de la Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Fundacion Jimenez Diaz (Clinica de la Concepcion)

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Virgen de la Victoria

    Málaga, 29010
    Spain

    Site Not Available

  • University College Hospital

    London, NW1 2BU
    United Kingdom

    Site Not Available

  • Univ.of California-San Diego Moores Cancer Center

    La Jolla, California 92093-1503
    United States

    Site Not Available

  • UCLA-Santa Monica Medical Center

    Santa Monica, California 90404
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Loyola University Medical Center

    Maywood, Illinois 60153
    United States

    Site Not Available

  • Ochsner Medical Center - New Orleans

    New Orleans, Louisiana 70121-2429
    United States

    Site Not Available

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • empty

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • Dartmouth Hitchock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106-2602
    United States

    Site Not Available

  • Mary Crowley Medical Research Center

    Dallas, Texas 75230
    United States

    Site Not Available

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