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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
177Lu-DOTA-TATE in four cycles in combination with escalated doses of olaparib
Dept of Oncology
Gothenburg, Sweden
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
To assess the number of participants with toxicity of 177Lu-DOTA-TATE in combination with olaparib measured by NCI Common Toxicity Criteria v 5.0
Time frame: up to 6 months after last treatment cycle
TTP
Time to progression
Time frame: 3 years
Response rate
Response rate (RECIST) at 3 and 12 months
Time frame: 12 months after last treatment cycle
OS
Overall survival
Time frame: 3 years
DOR
Duration of response
Time frame: 3 years
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