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Clinical Trials/EUCTR2019-002071-34-DK
EUCTR2019-002071-34-DK
Active, not recruiting
Phase 1

Allocation of patients with pre-treated solid tumors to anti-cancer therapy based on gene expression drug response prediction - a phase II basket trial

Vejle Hospital0 sites40 target enrollmentJune 11, 2019
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Vejle Hospital
Enrollment
40
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 11, 2019
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility 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)
  • •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

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

Outcomes

Primary Outcomes

Not specified

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