Improving Peptide Receptor Radionuclide Therapy With PARP Inhibitors

Sponsor
Erasmus Medical Center
Study ID
NCT05870423
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • olaparib — DRUG
    18 days olaparib during each cycle of PRRT

Study Details

This is a phase 1 dose-escalation study to determine the maximum tolerated dose of the PARP inhibitor olaparib in combination with PRRT in patients with a well-differentiated advanced gastroenteropancreatic NET (GEP NET), progressive after PRRT. As secondary objectives, efficacy, pharmacokinetics and biomarker response will be investigated.

Key Dates

Start date
Jun 1, 2022
Status verified
May 2025
Primary completion
Jan 1, 2027
Completion
Jan 1, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: PRRT + olaparib 100mg q.d.
    administration of the standard therapy of 7.4GBq 177lu-dotatate with the additional study medication olaparib 100mg q.d.
  • Experimental: PRRT + olaparib 100mg b.i.d.
    administration of the standard therapy of 7.4GBq 177lu-dotatate with the additional study medication olaparib 100mg b.i.d.
  • Experimental: PRRT + olaparib 200mg b.i.d.
    administration of the standard therapy of 7.4GBq 177lu-dotatate with the additional study medication olaparib 200mg b.i.d.
  • Experimental: PRRT + olaparib 300mg b.i.d.
    administration of the standard therapy of 7.4GBq 177lu-dotatate with the additional study medication olaparib 300mg b.i.d.

Primary Outcome Measure

Adverse events [ Time Frame: 3 years ]

Central Contacts

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