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177Lu-DOTA-TATE and Olaparib in Somatostatin Receptor Positive Tumours | Clinical Trials | Clareo Health

UNKNOWNPHASE1

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

Phase I Trial With 177Lu-DOTA-TATE and Olaparib in Somatostatin Receptor Positive Tumours

NCT04375267•Vastra Gotaland Region

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+7 more criteria

Exclusion Criteria

•Performance Status ECOG \> 1
•Well differentiated GEPNETs grad 1 and 2 (except aggressive grade 2 tumours with a poor prognosis and a Ki67 \> 15%)
•Loco-regional treatment during the last 3 months involving all of the measurable lesions
•Chemotherapy during the last 8 weeks or longer until no persisting toxicity exists. Earlier treatment with mTORi or TKI the last 4 weeks or until no persisting toxicity exists
•Previous treatment with 177Lu-DOTA-TATE or cis-/carboplatin
•Other concomitant nephrotoxic treatment
•Serious heart disease (NYHA III-IV)
•Previous radiotherapy including \>25% of active bone marrow volume
•Pregnancy and lactation
•Extensive liver metastases combined with impaired liver function (i.e. abnormal laboratory parameters (\> grad 1 CTCAE) or ascites)
+6 more criteria

Locations (1)

Dept of Oncology

Gothenburg, Sweden

Key Dates

Start Date

April 23, 2020

Primary Completion Date

June 30, 2024

Completion Date

June 30, 2024

Last Updated

November 14, 2023

Enrollment

ACTUAL participants

Conditions

Clinical Trial, Phase INeuroendocrine TumorsThymomaMesothelioma

Interventions

177Lu-DOTA-TATE + olaparib

DRUG

Lenvatinib Plus Pembrolizumab in Well Differentiated G3 Neuroendocrine Tumors

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Neuroendocrine TumorsWell-Differentiated Neuroendocrine Carcinoma+1 more

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RECRUITINGPHASE2

Lurbinectedin With or Without Avelumab in Small Cell Carcinoma of the Bladder (LASER)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 14, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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