177Lu-DOTA-TATE and Olaparib in Somatostatin Receptor Positive Tumours (NCT04375267) | Clinical Trial Compass
CompletedPhase 1
177Lu-DOTA-TATE and Olaparib in Somatostatin Receptor Positive Tumours
Sweden18 participantsStarted 2020-04-23
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histological or cytological diagnosis of neoplasia (not mandatory for meningioma)
* 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
* Measurable disease according to RECIST 1.1
* Evidence of somatostatin receptor positive disease detected by 68Ga-DOTA-TATE/TOC PET
* Progressive disease during the last 14 months based on CT or new lesions detected by 68Ga-DOTA-TATE PET.
* Performance status ECOG 0 - 1
* Life expectancy \> 6 months
* Age \>18 years, no upper age limit.
* Neutrophil count \>1,5 x 109/L
* Platelet count \>100 x 109/L
* Normal liver function regarding transaminases, PK and albumin. A raised bilirubin which can be considered an isolated effect of liver metastases is not a contraindication as long as the levels remain \<1.5 x ULN.
* GFR \> 50 ml/min
* Written informed consent from patients
* Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal subjects. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
* Women \<50 years of age would be consider…
What they're measuring
1
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Timeframe: up to 6 months after last treatment cycle