Trial Condition(s):
Thorough ECG (electrocardiogram) and drug interaction study with anetumab ravtansine and itraconazole
18329
Not Available
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
- Subjects must have histologically confirmed, locally advanced or metastatic solid cancers of the following histological types: a.) predominantly epithelial (≥50% tumor component) pleural or peritoneal mesothelioma b.) epithelial ovarian cancer (fallopian tube and primary peritoneal cancers are eligible) c.) adenocarcinoma of the pancreas, d.) triple-negative adenocarcinoma of the breast e.) non-small-cell adenocarcinoma of the lung f.) gastric cancer (including gastro-esophageal junction) g.) colon cancer h.) cholangiocarcinoma i.) Thymic carcinoma - Subjects must have no standard therapy available, or have actively refused standard therapy - Subjects must provide samples of archival tumor tissue collected and submitted anytime during the study - Subjects must have a life expectancy of at least 12 weeks - Subjects must have ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 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 obtained within 3 days before the start of anetumab ravtansine - Women of childbearing potential and fertile men must agree to use adequate contraception when sexually active. This applies from the time period between signing of the informed consent until at least 6 months after the last administration of the last study drug. Male patients with a female partner of childbearing potential must use a condom and ensure that an additional form of contraception is also used during treatment and until 6 months after last study drug administration.
- Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study, except cervical carcinoma in situ, treated basal cell carcinoma, superficial noninvasive bladder tumors or any previous cancer curatively 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 to drug-induced corneal epitheliopathy, or may interfere with diagnosis of treatment-emergent corneal epitheliopathy at the ophthalmologist’s or the investigator’s discretion - History or current evidence of -- biliary cirrhosis -- malignant biliary obstruction unless the bile flow to the gastrointestinal tract is maintained by a fully operational biliary stent -- CTCAE (Common Terminology Criteria for Adverse Events) Grade ≥2 bleeding disorder within 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 anetumab ravtansine - 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 in CYP2D6 metabolizing capacity
Locations | Status | |
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Locations UCLA-Santa Monica Medical Center Santa Monica, United States, 90404 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University Hospitals Cleveland Medical Center Cleveland, United States, 44106 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Henry Ford Health System Detroit, United States, 48202 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Washington University School of Medicine St. Louis, United States, 63110 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Mary Crowley Medical Research Center Dallas, United States, 75230 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Epworth HealthCare Richmond, Australia, 3122 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Blacktown Cancer & Haematology Centre Blacktown, Australia, 2148 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ciutat Sanitària i Universitaria de la Vall d'Hebron Barcelona, Spain, 08035 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fundacion Jimenez Diaz (Clinica de la Concepcion) Madrid, Spain, 28040 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Virgen de la Victoria Málaga, Spain, 29010 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Georges Francois Leclerc Dijon DIJON, France, 21079 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Henri Mondor CRETEIL, France, 94010 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital de la Timone - Marseille MARSEILLE, France, 13005 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CU Saint-Luc/UZ St-Luc BRUXELLES - BRUSSEL, Belgium, 1200 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UZ Gent GENT, Belgium, 9000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitair Medisch Centrum St. Radboud NIJMEGEN, Netherlands, 6525 GA | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nederlands Kanker Instituut AMSTERDAM, Netherlands, 1066 CX | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations VUmc AMSTERDAM, Netherlands, 1081 HV | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
An open label, Phase I study to assess the effect of itraconazole (CYP3A4 and P-gp inhibitor) on the pharmacokinetics of anetumab ravtansine and to assess the ECG effects, safety and immunogenicity of anetumab ravtansine given as a single agent and together with itraconazole in subjects with mesothelin-expressing advanced solid cancers
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1