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. - Anetumab ravtansine drug interaction study

Bayer0 sites8 target enrollmentTBD

Conditionseoplasmata, maligne en niet-gespecificeerd: lokaal gevorderde of metastatische solide kankersoorten met mesotheline-expressie.Mesothelin-expressing advanced solid cancers

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: eoplasmata, maligne en niet-gespecificeerd: lokaal gevorderde of metastatische solide kankersoorten met mesotheline-expressie.
Sponsor: Bayer
Enrollment: 8
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Investigators

Sponsor

Bayer

Eligibility Criteria

Inclusion Criteria

•\- 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 or, in the investigator\*s opinion, treatment in this study is clinically and ethically acceptable for the subject.;\- Subjects must provide samples of archival tumor tissue collected and submitted anytime during the study.

Exclusion Criteria

•\- 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 greater than or equal to 3 years before the start of anetumab ravtansine.;\- New or progressive brain or meningeal or spinal metastases.;\- Poor CYP2D6 metabolizers based on the screening test for CYP2D6 genetic polymorphisms.;\- 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;\- Left ventricular ejection fraction (LVEF) \<50% at screening.;\- Have QTc \>450 ms or heart rate \>\=100 bpm or \<\=45 bpm at screening.;\- Solid organ or bone marrow transplantation.;\- Major surgery or significant trauma within 4 weeks before the start of anetumab ravtansine.