Phase
Condition
Neoplasms
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Subjects must have histologically confirmed, locally advanced or metastatic solidcancers of the following histological types:
predominantly epithelial (≥50% tumor component) pleural or peritonealmesothelioma
epithelial ovarian cancer (fallopian tube and primary peritoneal cancers areeligible)
adenocarcinoma of the pancreas,
triple-negative adenocarcinoma of the breast
non-small-cell adenocarcinoma of the lung
gastric cancer (including gastro-esophageal junction)
colon cancer
cholangiocarcinoma
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
Connect with a study center
Blacktown Cancer & Haematology Centre
Blacktown, New South Wales 2148
AustraliaSite Not Available
Epworth HealthCare
Richmond, Victoria 3122
AustraliaSite Not Available
CU Saint-Luc/UZ St-Luc
Bruxelles - Brussel, 1200
BelgiumSite Not Available
UZ Gent
Gent, 9000
BelgiumSite Not Available
UZ Leuven Gasthuisberg
Leuven, 3000
BelgiumSite Not Available
Hôpital Henri Mondor
Creteil, 94010
FranceSite Not Available
Centre Georges Francois Leclerc Dijon
Dijon, 21079
FranceSite Not Available
Hôpital de la Timone - Marseille
Marseille, 13005
FranceSite Not Available
Nederlands Kanker Instituut
Amsterdam, 1066 CX
NetherlandsSite Not Available
VUmc
Amsterdam, 1081 HV
NetherlandsSite Not Available
Universitair Medisch Centrum St. Radboud
Nijmegen, 6525 GA
NetherlandsSite Not Available
Ciutat Sanitària i Universitaria de la Vall d'Hebron
Barcelona, 08035
SpainSite Not Available
Fundacion Jimenez Diaz (Clinica de la Concepcion)
Madrid, 28040
SpainSite Not Available
Hospital Virgen de la Victoria
Málaga, 29010
SpainSite Not Available
University College Hospital
London, NW1 2BU
United KingdomSite Not Available
Univ.of California-San Diego Moores Cancer Center
La Jolla, California 92093-1503
United StatesSite Not Available
UCLA-Santa Monica Medical Center
Santa Monica, California 90404
United StatesSite Not Available
Emory University
Atlanta, Georgia 30322
United StatesSite Not Available
Loyola University Medical Center
Maywood, Illinois 60153
United StatesSite Not Available
Ochsner Medical Center - New Orleans
New Orleans, Louisiana 70121-2429
United StatesSite Not Available
Henry Ford Health System
Detroit, Michigan 48202
United StatesSite Not Available
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
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St. Louis, Missouri 63110
United StatesSite Not Available
Dartmouth Hitchock Medical Center
Lebanon, New Hampshire 03756
United StatesSite Not Available
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106-2602
United StatesSite Not Available
Mary Crowley Medical Research Center
Dallas, Texas 75230
United StatesSite Not Available
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