Phase I/II, Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin in Combination with Irinotecan in Pretreated Patients with Selected Advanced Solid Tumors.

Pharma Mar S.A.0 sites320 target enrollmentMarch 3, 2023

Overview

No summary available.

Registry

who.int

Start Date

March 3, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\)Voluntarily signed and dated written informed consent prior to any specific\-study procedure
•2\)Age \=18years
•3\)ECOG performance status \=1
•4\)Life expectancy \=3 months
•5\)Histologically or cytologically confirmed diagnosis of advanced disease of any of the following tumor types:
•\- Lurbinectedin Escalation Group and Irinotecan Escalation Group:
•a)Glioblastoma
•b)Soft\-tissue sarcoma (excluding GIST)
•c)Endometrial carcinoma
•d)Epithelial ovarian carcinoma (including primary peritoneal disease and/or fallopian tube carcinomas and/or endometrial adenocarcinomas) regardless of platinum sensitivity

•1\)Concomitant diseases/conditions:
•a)History or presence of unstable angina, myocardial infarction, congestive heart failure, or clinically significant valvular heart disease within the previous year
•b)Symptomatic arrhythmia or any uncontrolled arrhythmia requiring ongoing treatment
•c) Myopathy or any clinical situation that causes significant and persistent elevation of CPK (\> 2\.5 × ULN in two different determinations performed one week apart)
•d) Ongoing chronic alcohol consumption or cirrhosis with Child\-Pugh score B or C. Known Gilbert disease
•e) Active uncontrolled infection
•f) Known human immunodeficiency virus (HIV) or known hepatitis C virus (HCV) infection or active hepatitis B
•g) Any past or present chronic inflammatory colon and/or liver disease, past intestinal obstruction, pseudo or subocclusion or paralysis
•h) Evident symptomatic pulmonary fibrosis or interstitialpneumonitis, pleural or cardiac effusion rapidly increasing and/or necessitating prompt local treatment within seven days
•i) Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study