A phase I-IIa clinical study on the investigational anticancer drug J1 in patients with advanced cancer. A prospective, single armed, open label, dose-finding phase I-IIa study.

Oncopeptides AB0 sites40 target enrollmentDecember 19, 2005

Overview

No summary available.

Registry

who.int

Start Date

December 19, 2005

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•At least 18 years of age.
•Histologically confirmed diagnosis of malignancy.
•Advanced disease not amenable to standard treatment.
•Pharmacological treatment attempt justified.
•Females of childbearing potential should use adequate contraception (oral or injectable contraceptives, hormone releasing intrauterine device) throughout the study.
•Signed informed consent.
•The patient has a central line for infusion or accepts to have a central line inserted.
•Preserved major organ functions, i.e. neutrophils \= 1,5 x 109/l, platelets \= 100 x 109/l, bilirubin \<30 µmol/L, GFR \>50 ml/min (based on cystatine C) and normal prothrombine complex/INR unless the patient is treated with Waran.
•For phase IIa of the study, the patients should have measurable tumour of the following types; breast cancer, ovary cancer, lymphoma, haematological malignancy, lung cancer (NSCLC, SCLC and mesothelioma) and bladder cancer. Other malignancies should be discussed between PI and Oncopeptides representative.
•Are the trial subjects under 18? no

•Systemic anti\-tumour therapy within 4 weeks prior to study drug administration Day 1 visit (6 weeks for nitrosurea or mitomycin C) and/or radiotheraphy within 1 week prior to study drug administration Day 1\.
•Ongoing infection or other major recent or ongoing disease that, according to the investigator, poses an unacceptable risk to the patient.
•Karnofsky performance status \< 70\.
•Current participation in any other interventional clinical study.
•Contraindications to the investigational product, e.g. known or suspected hypersensitivity.
•Pregnancy or lactation.
•Lack of suitability for participation in the study, for any reason, as judged by the Investigator.