Treatment of cancer. MedDRA version: 8 Level: HLT Classification code 10029105
Conditions
Interventions
Product Name: J1 Concentrate for solution for infusion 50 mg/ml
Product Code: J1 concentrate
Pharmaceutical Form: Concentrate for solution for infusion
CAS Number: 380449-54-7
Current Sponsor code: J1
Sponsors
Oncopeptides AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 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 Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To define the recommended phase II dose of J1 (phase I). To confirm recommended phase II dose and investigate tumor response (phase IIa).;Secondary Objective: To establish the toxicity profile of J1. To define the dose limiting toxicities of J1. To study the pharmacokinetic profile of J1. To document any tumour response of J1 (phase I).;Primary end point(s): - Safety parameters from treatment cycle 1 to define/confirm RPTD (phase I and IIa). - Radiological tumour response after cycle 3 and 6/last cycle (phase IIa). | — |
Countries
Sweden
Outcome results
None listed