Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-25 @ 7:35 PM
Study NCT ID:
NCT03562832
Status:
COMPLETED
Last Update Posted:
2025-01-23
First Post:
2018-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigation of Anti-tumour Effect and Tolerability of the PARP Inhibitor 2X-121 in Patients With Metastatic Breast Cancer Selected by the 2X-121 DRP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000611123', 'term': 'stenoparib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-22', 'studyFirstSubmitDate': '2018-04-26', 'studyFirstSubmitQcDate': '2018-06-07', 'lastUpdatePostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anti-tumour efficacy after treatment with 600 mg 2X-121 as single oral agent in a 21-days cycle in mBC patients selected by the 2X-121 DRP', 'timeFrame': 'one year', 'description': 'Overall tumor response according to RECIST'}], 'secondaryOutcomes': [{'measure': 'Progression free survival (PFS) after administration of 2X-121 in patients with mBC', 'timeFrame': 'one year', 'description': 'Timespan'}, {'measure': 'Duration of objective response after administration of 2X-121 in patients with mBC', 'timeFrame': 'one year', 'description': 'Timespan'}, {'measure': 'Overall survival (OS) after administration of 2X-121 in patients with mBC', 'timeFrame': 'one year', 'description': 'Timespan'}, {'measure': 'Performance status (ECOG)', 'timeFrame': 'one year', 'description': 'To evaluate change in patient performance status by ECOG (Eastern Cooperative Oncology Group) Performance Status by a 6-step classification system'}, {'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0', 'timeFrame': 'one year', 'description': 'Adverse Events as assessed by CTCAE v4. to evaluate safety profile after administration of 2X-121 in patients with mBC'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PARP inhibitor', 'Drug Response Prediction (DRP)', 'Tankyrase 1/2 inhibitor', 'mRNA biomarker'], 'conditions': ['Metastatic Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.oncologyventure.com', 'label': 'Official Homepage of Sponsor'}]}, 'descriptionModule': {'briefSummary': '2X-121 is a small molecule targeted inhibitor of Poly ADP ribose polymerase (PARP), a key enzyme involved in DNA damage repair in cancer cells. The PARP inhibitor demonstrated clinical activity in a prior Phase 1 study in a number of solid tumors. 2X-121 has a novel dual-inhibitory action against both PARP 1/2 and Tankyrase 1/2. The molecule is also active in P-glycoprotein expressing cells, suggesting it may overcome some of the PARP inhibitor resistance.\n\nThe Phase 2 study is using 2x-121 DRP® biomarker in metastatic breast cancer patients to identify patients likely to respond to and benefit from treatment with 2X-121.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed informed consent form.\n* Age 18 years or older.\n* Histologically or cytological documented mBC (independent of hormone receptor, HER2 status and BRCA1 or 2 status) relapsed in 2 or more different prior therapies.\n* Measurable disease by CT scan or MRI.\n* With a drug response prediction (DRP) for 2X-121 with an outcome measured as being in the upper 20% likelihood of response.\n* Prior chemotherapy or hormone therapy for metastatic breast cancer is allowed.\n* Performance status of ECOG \\<= 1\n* Recovered to Grade 1 or less from prior surgery or from acute toxicities of prior radiotherapy, or from treatment with cytotoxic, hormonal or biologic agents).\n* \\>= 2 weeks must have elapsed since any prior surgery or therapy with G-CSF and GM-CSF.\n* Patients with intracranial disease must be on stable or decreased level of steroid therapy (e.g. dexamethasone) for at least 7 days prior to baseline MRI. Non-enzymatic inducing ant-epileptic drugs are allowed.\n* Adequate conditions as evidenced by the following clinical laboratory values:\n\n * Absolute neutrophils count (ANC) \\>= 1.5 x 10E9/L\n * Haemoglobin is at least 4.6 mmol/L\n * Platelets \\>= 100 x 10E9 /L\n * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\<= 2.5 x ULN\\*\n * Serum bilirubin \\<= 1.5 ULN\n * Alkaline phosphatase \\<= 2.5 x ULN\\*\n * Creatinine \\<= 1.5 ULN\n * Blood urea within normal limits\n * Creatinine clearance within normal limits. \\*In case of known liver metastases with ALT and AST \\<= 5 x ULN and/or alkaline phosphatase \\<= 5 x ULN. Patients who do not conform to the transaminase and/or alkaline phosphatase inclusion criteria, but who by the PI are considered in good PS and otherwise eligible for inclusion, and where the transaminase and/or alkaline phosphatase levels are considered elevated due to other reasons than deteriorated lever capacity, may be considered for inclusion based on conferred agreement between PI and sponsor.\n* Life expectancy equal or longer than 3 months.\n* Sexually active females of child-producing potential must use adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception) for the study duration and at least six months afterwards.\n\nExclusion Criteria:\n\n* \\- Concurrent chemotherapy, radiotherapy, hormonal therapy, or other investigational drug except non-disease related conditions (e.g. insulin for diabetes) during study period.\n* Other malignancy with exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ within 5 years prior to entering the study.\n* Previous treatment with PARP inhibitors\n* Any active infection requiring parenteral or oral antibiotic treatment.\n* Has known HIV positivity.\n* Has known active hepatitis B or C.\n* Has clinical significant (i.e. active) cardiovascular disease:\n\n * Stroke within \\<= 6 months prior to day 1\n * Transient ischemic attach (TIA) within \\<= 6 months prior to day 1\n * Myocardial infarction within \\<= 6 months prior to day 1\n * Unstable angina\n * New York Hart Association (NYHA) Grade II or greater congestive heart failure (CHF)\n * Serious cardiac arrhythmia requiring medication\n* Mental status is not fit for clinical study or CNS disease including symptomatic epilepsy.\n* Other medications or conditions, including surgery, that in the Investigator's opinion would contraindicate study participation of safety reasons or interfere with the interpretation of study results\n* Inability to take oral medication, or malabsorption syndrome or any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) that might impair the bioavailability of 2X-121.\n* Requiring immediate palliative treatment of any kind including surgery and/or radiotherapy.\n* Female patients who are pregnant or breast-feeding (pregnancy test with a positive result before study entry)"}, 'identificationModule': {'nctId': 'NCT03562832', 'briefTitle': 'Investigation of Anti-tumour Effect and Tolerability of the PARP Inhibitor 2X-121 in Patients With Metastatic Breast Cancer Selected by the 2X-121 DRP', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allarity Therapeutics'}, 'officialTitle': 'Phase II, Open Label Clinical Study to Investigate Anti-tumour Effect and Tolerability of the PARP Inhibitor 2X-121 in Patients With Metastatic Breast Cancer Selected by the 2X-121 DRP', 'orgStudyIdInfo': {'id': 'OV-121'}, 'secondaryIdInfos': [{'id': 'SMR-3475', 'type': 'OTHER', 'domain': 'Smerud Medical Research International'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PARP inhibitor 2X-121', 'description': '600 mg PARP inhibitor 2X-121 as single daily oral agent in mBC patients', 'interventionNames': ['Drug: PARP inhibitor 2X-121']}], 'interventions': [{'name': 'PARP inhibitor 2X-121', 'type': 'DRUG', 'description': '600 mg PARP inhibitor 2X-121 as single daily oral agent in mBC patients', 'armGroupLabels': ['PARP inhibitor 2X-121']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Herlev and Gentofte Hospital, Herlev Ringvej 75, DK-2730 Herlev', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}, {'zip': '7100', 'city': 'Vejle', 'country': 'Denmark', 'facility': 'Vejle Sygehus', 'geoPoint': {'lat': 55.70927, 'lon': 9.5357}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allarity Therapeutics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Smerud Medical Research International AS', 'class': 'OTHER'}, {'name': 'Danish Breast Cancer Cooperative Group', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}