Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2026-03-10 @ 7:22 PM
Study NCT ID:
NCT03135951
Status:
COMPLETED
Last Update Posted:
2020-11-13
First Post:
2017-04-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of SPI-2012 (Eflapegrastim) in Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) Chemotherapy
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': 'C583329', 'term': 'eflapegrastim'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2018-05-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-11', 'studyFirstSubmitDate': '2017-04-20', 'studyFirstSubmitQcDate': '2017-04-26', 'lastUpdatePostDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak Plasma Concentration (Cmax)', 'timeFrame': 'Up to 42 days', 'description': 'PK samples will be collected at predetermined time intervals and Peak Concentration is measured at highest value among all concentrations.'}, {'measure': 'Area under the plasma concentration versus time curve (AUC)', 'timeFrame': 'Up to 42 days', 'description': 'PK samples will be collected at predetermined time intervals. AUC is calculated in the plot of plasma concentration versus time curve'}], 'secondaryOutcomes': [{'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.03', 'timeFrame': '6 months', 'description': 'An AE is defined as any untoward medical occurrence in a patient or clinical investigation patient, temporally associated with the use of a medicinal product or study procedure, whether or not considered related to the medicinal product. A treatment-emergent AE (TEAE) is any AE that occurs from the first dose of study treatment through 35 (±5) days after the date of patient early discontinuation.'}, {'measure': 'Population slope of the relationship between the change from baseline in QTc intervals and plasma concentrations of SPI-2012', 'timeFrame': 'Up to 42 days', 'description': 'A linear mixed effects modeling approach will be used to quantify the relationship between the plasma concentrations of SPI-2012 and change from baseline in QT intervals (∆QTc). Plasma concentration, intercept, and subject are to be included as random effects.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Cancer', 'Pharmacokinetics', 'Long-acting Myeloid Growth Factor', 'Early Stage Breast Cancer', 'Docetaxel + Cyclophosphamide (TC) Chemotherapy'], 'conditions': ['Breast Cancer', 'Pharmacokinetics']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the pharmacokinetic (PK) profile of a fixed dose of SPI-2012 in patients with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC) chemotherapy, as measured by the serum concentration of SPI-2012 on specific days following drug administration.', 'detailedDescription': "This is a Phase 1, single-arm multicenter study to evaluate the PK and safety of SPI-2012 (a long acting myeloid growth factor) in breast cancer patients treated with TC chemotherapy.\n\nApproximately 25 patients will be enrolled.\n\nEach cycle will be 21 days and patients will receive 4 cycles of treatment with 2 additional cycles based on the investigator's discretion. On Day 1 of each cycle, patients will receive TC chemotherapy and on Day 2 of each cycle, patients will receive SPI-2012.\n\nPharmacokinetics will be evaluated only in Cycles 1 and 3."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed, histologically confirmed early-stage breast cancer, defined as operable Stage I to Stage IIIA breast cancer.\n* Candidate to receive adjuvant or neoadjuvant TC chemotherapy.\n* ANC ≥1.5x10\\^9/L\n* Platelet count ≥100x10\\^9/L\n* Hemoglobin \\>9 g/dL\n* Calculated creatinine clearance \\>50 mL/min\n* Total bilirubin ≤1.5 mg/dL\n* AST and ALT ≤2.5xULN\n* Alkaline phosphatase ≤2.0xULN\n* ECOG ≤2\n\nExclusion Criteria:\n\n* Active concurrent malignancy (except non melanoma skin cancer or carcinoma in situ of cervix) or life-threatening disease. If history of prior malignancies or contralateral breast cancer, must be disease free for at least 5 years.\n* Known sensitivity to E. coli derived products or known sensitivity to any of the products to be administered during dosing.\n* Concurrent adjuvant cancer therapy.\n* Locally recurrent/metastatic breast cancer.\n* Previous exposure to filgrastim, pegfilgrastim, or other G-CSF products in clinical development within 12 months prior to the administration of study drug.\n* Active infection, receiving antibiotics or any serious underlying medical condition which would impair the ability of the patient to receive protocol-specified treatment.\n* Prior bone marrow or hematopoietic stem cell transplant\n* Used any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study.\n* Prior radiation therapy within 30 days prior to enrollment.\n* Major surgery within 30 days prior to enrollment.'}, 'identificationModule': {'nctId': 'NCT03135951', 'briefTitle': 'Pharmacokinetics of SPI-2012 (Eflapegrastim) in Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) Chemotherapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Spectrum Pharmaceuticals, Inc'}, 'officialTitle': 'Pharmacokinetics of SPI-2012 (Eflapegrastim) in Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) Chemotherapy', 'orgStudyIdInfo': {'id': 'SPI-GCF-301-PK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SPI-2012', 'description': '* SPI-2012 (13.2 mg/0.6 mL fixed dose, equivalent to 3.6 mg G-CSF per cycle)\n* Supplied in 1 mL prefilled, single-use syringes for subcutaneous injection\n* Administered on Day 2 of each cycle after TC administration', 'interventionNames': ['Drug: SPI-2012']}], 'interventions': [{'name': 'SPI-2012', 'type': 'DRUG', 'otherNames': ['Rolontis™', 'Eflapegrastim'], 'description': 'Supplied in prefilled, single-use syringes for subcutaneous injection and administered on Day 2 of each cycle.', 'armGroupLabels': ['SPI-2012']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92804', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Research Center', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}], 'overallOfficials': [{'name': 'Shanta Chawla, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Spectrum Pharmaceuticals, Inc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spectrum Pharmaceuticals, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}