EUCTR2005-002901-22-SEActive, not recruitingNot Applicable
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.
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Oncopeptides AB
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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 <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
- •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
- •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.
Investigators
Similar Trials
Recruiting
Phase 2
A Phase I-II Clinical Study of Nimotuzumab (TheraCIM h-R3) in Combination with External Radiotherapy in Stage IIB, III and IV Non-Small Cell Lung Cancer (NSCLC)ACTRN12610000571077YM BioSciences Inc.128
Active, not recruiting
Phase 1
Study of safety and efficacy of genome-edited hematopoietic stem and progenitor cells in sickle cell disease (SCD)EUCTR2019-003489-41-ITOVARTIS PHARMA AG30
Completed
Phase 1
Trial to evaluate 3mg dose of Covid Vaccine of Cadila healthcare LimitedCTRI/2021/03/032051Cadila Healthcare Limited150
Active, not recruiting
Phase 1
A first-in-human study of UX053 in Patients with Glycogen Storage Disease type III (GSD III)Glycogen Storage Disease Type III (GSD III)MedDRA version: 20.1Level: PTClassification code 10053250Term: Glycogen storage disease type IIISystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2021-000903-19-ITTRAGENYX PHARMACEUTICAL INC.30
Active, not recruiting
Phase 1
A first-in-human study of UX053 in Patients with Glycogen Storage Disease type III (GSD III)Glycogen Storage Disease Type III (GSD III)MedDRA version: 20.1Level: PTClassification code 10053250Term: Glycogen storage disease type IIISystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2021-000903-19-ESltragenyx Pharmaceutical Inc.30