TheranosticTrials.org

Clinical Trial · NCT04375267

177Lu-DOTA-TATE and Olaparib in Somatostatin Receptor Positive Tumours

Overview

This is a phase I study of 177Lu-DOTA-TATE in combination with the PARP-inhibitor olaparib for treatment of patients with somatostatin receptor positive tumours detected by 68Ga-DOTA-TATE/TOC PET. The combination of a PARP inhibitor that will specifically target the repair mechanism, with ionising radiation causing SSB's might overcome the repair dependent survival of the tumour cells, making them more sensitive to β-emission and increase the probability of tumour cell death.

Sponsor

Unknown Organization

Phase

Phase 1

ClinicalTrials.gov

NCT04375267

Drug / Compound

DOTATATE

Isotope(s):
Target(s):
  • SSTR2
Ligand Class: Peptides
Chelator: DOTA

DOTATOC

Isotope(s):
Target(s):
  • SSTR2
Ligand Class: Peptides
Chelator: DOTA

DOTATATE

Isotope(s):
Target(s):
  • SSTR2
Ligand Class: Peptides
Chelator: DOTA

Eligibility

Inclusion

  • Progressive disease during the last 14 months based on CT or new lesions detected by 68Ga-DOTA-TATE PET.
  • Evidence of somatostatin receptor positive disease detected by 68Ga-DOTA-TATE/TOC PET
  • GEPNETs grade 3 or aggressive grade 2 tumours with a poor prognosis and a Ki67 \> 15% OR neuroendocrine tumours NOS after standard therapy OR thymomas/tumours of other origin after standard therapy OR meningiomas after standard therapy not suitable for surgery or radiotherapy
  • Evidence of regional or distant metastases or localised disease not accessible for complete resection

Exclusion

  • Extensive liver metastases combined with impaired liver function (i.e. abnormal laboratory parameters (\> grad 1 CTCAE) or ascites)