Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT04375267
Status:
UNKNOWN
Last Update Posted:
2023-11-14
First Post:
2020-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
177Lu-DOTA-TATE and Olaparib in Somatostatin Receptor Positive Tumours
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D013945', 'term': 'Thymoma'}, {'id': 'D008654', 'term': 'Mesothelioma'}], 'ancestors': [{'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018193', 'term': 'Neoplasms, Complex and Mixed'}, {'id': 'D013953', 'term': 'Thymus Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D018301', 'term': 'Neoplasms, Mesothelial'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C531550', 'term': 'olaparib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-13', 'studyFirstSubmitDate': '2020-04-27', 'studyFirstSubmitQcDate': '2020-05-03', 'lastUpdatePostDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v5.0', 'timeFrame': 'up to 6 months after last treatment cycle', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'TTP', 'timeFrame': '3 years', 'description': 'Time to progression'}, {'measure': 'Response rate', 'timeFrame': '12 months after last treatment cycle', 'description': 'Response rate (RECIST) at 3 and 12 months'}, {'measure': 'OS', 'timeFrame': '3 years', 'description': 'Overall survival'}, {'measure': 'DOR', 'timeFrame': '3 years', 'description': 'Duration of response'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Clinical Trial, Phase I', 'Neuroendocrine Tumors', 'Thymoma', 'Mesothelioma']}, 'referencesModule': {'references': [{'pmid': '34829796', 'type': 'DERIVED', 'citation': 'Hallqvist A, Svensson J, Hagmarker L, Marin I, Ryden T, Beauregard JM, Bernhardt P. Optimizing the Schedule of PARP Inhibitors in Combination with 177Lu-DOTATATE: A Dosimetry Rationale. Biomedicines. 2021 Oct 29;9(11):1570. doi: 10.3390/biomedicines9111570.'}]}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological or cytological diagnosis of neoplasia (not mandatory for meningioma)\n* 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\n* Evidence of regional or distant metastases or localised disease not accessible for complete resection\n* Measurable disease according to RECIST 1.1\n* Evidence of somatostatin receptor positive disease detected by 68Ga-DOTA-TATE/TOC PET\n* Progressive disease during the last 14 months based on CT or new lesions detected by 68Ga-DOTA-TATE PET.\n* Performance status ECOG 0 - 1\n* Life expectancy \\> 6 months\n* Age \\>18 years, no upper age limit.\n* Neutrophil count \\>1,5 x 109/L\n* Platelet count \\>100 x 109/L\n* 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.\n* GFR \\> 50 ml/min\n* Written informed consent from patients\n* 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:\n\n * Women \\<50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).\n * Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \\>1 year ago, had chemotherapy-induced menopause with last menses \\>1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).\n\nExclusion Criteria:\n\n* Performance Status ECOG \\> 1\n* Well differentiated GEPNETs grad 1 and 2 (except aggressive grade 2 tumours with a poor prognosis and a Ki67 \\> 15%)\n* Loco-regional treatment during the last 3 months involving all of the measurable lesions\n* 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\n* Previous treatment with 177Lu-DOTA-TATE or cis-/carboplatin\n* Other concomitant nephrotoxic treatment\n* Serious heart disease (NYHA III-IV)\n* Previous radiotherapy including \\>25% of active bone marrow volume\n* Pregnancy and lactation\n* Extensive liver metastases combined with impaired liver function (i.e. abnormal laboratory parameters (\\> grad 1 CTCAE) or ascites)\n* Symptomatic CNS metastases (e.g. requiring corticosteroid treatment) Symptomatic treatment for meningiomas or corticosteroids due to treatment related swelling is however allowed\n* Ongoing treatment with interferon. This treatment should be suspended a minimum of 4 wees before treatment with 177Lu-DOTA-TATE, or longer if there is persisting signs of toxicity\n* Patients who have a another metastatic tumor diagnosis\n* Known or expected hypersensitivity to 177Lu-DOTA-TATE, 68Ga- DOTA-TATE/TOC or any of their excipients\n* History of psychiatric disease/condition that may interfere with the objectives and assessments of the study\n* Female subjects who are pregnant or breastfeeding or subjects of reproductive potential who are not willing to employ effective birth control methods (Pearl index \\<1) from screening to 6 months after the last dose of olaparib'}, 'identificationModule': {'nctId': 'NCT04375267', 'acronym': 'LuPARP', 'briefTitle': '177Lu-DOTA-TATE and Olaparib in Somatostatin Receptor Positive Tumours', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Vastra Gotaland Region'}, 'officialTitle': 'Phase I Trial With 177Lu-DOTA-TATE and Olaparib in Somatostatin Receptor Positive Tumours', 'orgStudyIdInfo': {'id': '2019-001700-37'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '177Lu-DOTA-TATE and olaparib', 'interventionNames': ['Drug: 177Lu-DOTA-TATE + olaparib']}], 'interventions': [{'name': '177Lu-DOTA-TATE + olaparib', 'type': 'DRUG', 'description': '177Lu-DOTA-TATE in four cycles in combination with escalated doses of olaparib', 'armGroupLabels': ['177Lu-DOTA-TATE and olaparib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41345', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Dept of Oncology', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vastra Gotaland Region', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Advanced Accelerator Applications', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}