Allocation of patients with relapse of cancer to treatment with new drugs based on tumor biopsy

Phase 1

• Conditions: Breast cancerOvarian cancerLung cancerColorectal cancerProstate cancerPancreatic cancer; MedDRA version: 20.0Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10033130Term: Ovarian cancer NOSSystem Organ Class: 100000004864; MedDRA version: 20.1Level: LLTClassification code 10080083Term: Advanced lung cancerSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10033605Term: Pancreatic cancer metastaticSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10036910Term: Prostate cancer NOSSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-002071-34-DK
• Lead Sponsor: Vejle Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-11
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

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)
oNeutrophils (ANC) = 1.5x10^9/L
oPlatelet count = 100x10^9/L
oHemoglobin = 9.0 g/dL or = 5,6 mmol/L
oSerum bilirubin = 2,0 x ULN
oSerum alanine aminotransaminase = 2.5 x ULN
oSerum 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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br>Primary endpoint: Response rate ;Timepoint(s) of evaluation of this end point: Every 2 months until progression

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Primary sub-protocol, phase II basket trial:<br>1. Progression free survival (PFS)<br>2. Overall survival (OS)<br>3. Quality of life (QoL);Timepoint(s) of evaluation of this end point: Primary sub-protocol, phase II basket trial:<br>1. Every 2 months until progression or death<br>2. One year after end of treatment<br>3. Every 2 months until progression or death<br>