Breast cancer Ovarian cancer Lung cancer Colorectal cancer Prostate cancer Pancreatic cancer MedDRA version: 20.0 Level: LLT Classification code 10072737 Term: Advanced breast cancer System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10033130 Term: Ovarian cancer NOS System Organ Class: 100000004864 MedDRA version: 20.1 Level: LLT Classification code 10080083 Term: Advanced lung cancer System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Cla
Conditions
Interventions
Product Name: LiPlaCis
Pharmaceutical Form: Concentrate for dispersion for infusion
INN or Proposed INN: CISPLATIN
Other descriptive name: CISPLATIN
Concentration unit: ml millilitre(s)
Concentration
Sponsors
Vejle Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histopathologically verified advanced, metastatic cancer (breast, ovarian, lung, prostate, colorectal, pancreatic) without curatively intended treatment options. • Measurable disease according to RECIST 1.1, or GCIG CA125 criteria for ovarian cancer, or PCWG3 criteria for prostate cancer • Performance status 0-1 • Age = least 18 years • Adequate bone marrow, liver and renal function (within 7 days prior to inclusion) o Neutrophils (ANC) = 1.5x10^9/L o Platelet count = 100x10^9/L o Hemoglobin = 9.0 g/dL or = 5,6 mmol/L o Serum bilirubin = 2,0 x ULN o Serum alanine aminotransaminase = 2.5 x ULN o Serum creatinine = 1.5 x ULN (a creatinine above 1.5 x ULN measured or calculated GFR must be at least 50 mL/min. • At least 2 previous chemotherapy regimens • Written and orally informed consent • Consent to translational research and biobank • Eligible for chemotherapy according to investigator • Life expectancy > 3 months • Contraception for fertile women and for male patients with a fertile partner. Intrauterine device, vasectomy of a female subject’s male partner, and hormonal contraceptive are acceptable. 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: • Clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) = 1 year before enrollment • Active, serious infection, bleeding, or other serious disease • Other active, malignant disease, except basocellular or squamous skin cancer and carcinoma in situ cervicis uteri • Fertile women not willing to use effective methods of contraception during and 6 months after end of treatment • Other systemic treatment or radiotherapy treatment within 28 days prior to treatment start • Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of the master protocol is to investigate the overall anti-cancer effect of drug response prediction (DRP) directed therapy with LiPlaCis, 2X-121, or Irofulven in a phase II basket trial including six common tumor types;Secondary Objective: Not applicable;Primary end point(s): Primary sub-protocol, phase II basket trial: Primary endpoint: Response rate ;Timepoint(s) of evaluation of this end point: Every 2 months until progression | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Primary sub-protocol, phase II basket trial: 1. Progression free survival (PFS) 2. Overall survival (OS) 3. Quality of life (QoL);Timepoint(s) of evaluation of this end point: Primary sub-protocol, phase II basket trial: 1. Every 2 months until progression or death 2. One year after end of treatment 3. Every 2 months until progression or death | — |
Countries
Denmark
Contacts
Public ContactClinital Trial Unit
Vejle Hospital
Outcome results
None listed