Ignite Creation Date:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2025-12-28 @ 5:41 PM
Study NCT ID:
NCT01933061
Status:
WITHDRAWN
Last Update Posted:
2014-02-04
First Post:
2013-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Determine Efficacy and Safety of CC-486 With Nab-Paclitaxel Versus Nab-Paclitaxel in Patients With Chemotherapy naïve Metastatic Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'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': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068196', 'term': 'Albumin-Bound Paclitaxel'}, {'id': 'C520255', 'term': '130-nm albumin-bound paclitaxel'}], 'ancestors': [{'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D000418', 'term': 'Albumins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Strategic decision not to proceed with the opening of this study. There are no concerns over the safety or quality of the investigational products involved.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-03', 'studyFirstSubmitDate': '2013-08-28', 'studyFirstSubmitQcDate': '2013-08-28', 'lastUpdatePostDateStruct': {'date': '2014-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival (PFS)', 'timeFrame': 'Up to 24 months', 'description': 'PFS is defined as the time from randomization date to disease progression according to RECIST response guideline'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': 'Up to 24 months', 'description': 'OS is defined as the time from the date of randomization to the date of death.'}, {'measure': 'PFS', 'timeFrame': 'Up to 24 months', 'description': 'PFS based on investigator assessment; PFS is defined as the time from randomization date to disease progression according to RECIST response guideline'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Up to 24 months', 'description': 'Number (%) of subject who achieve an objective complete or partial response.'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'Up to 24 months', 'description': 'Number (%) of subject with Stable Disease (SD) ≥ for 18 weeks or complete or partial response.'}, {'measure': 'Safety', 'timeFrame': 'Up to 24 months', 'description': 'Incidence and severity of Adverse events (AE) will be analyzed in terms of treatment-emergent AEs defined to be any AE that begin or worsen in severity after study drug initiation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Skin cancer, Melanoma'], 'conditions': ['Metastatic Melanoma']}, 'descriptionModule': {'briefSummary': 'A phase 2, open-label randomized, multicenter trial to compare CC-486 in combination with Abraxane administered weekly with respect to overall survival, objective tumor response rate and Progression-Free Survival (PFS) in participants diagnosed with metastatic malignant melanoma.', 'detailedDescription': 'The study will consist of the following phases:\n\n* Screening (Baseline) Assessments: Performed within 21 days of randomization.\n* Randomization: Subjects will be randomized within 21 days of starting their Baseline assessments.\n* Treatment: Therapy may continue in the absence of clinically significant disease progression and unacceptable toxicity.\n* Response Assessments: Subjects will be evaluated by investigators for CR, PR, stable or progressive disease every 6 weeks from the start of treatment until progressive disease is documented.\n\nResponders and subjects with stable disease (SD) should continue on study unless they develop unacceptable toxicity, they start a new anticancer therapy, withdrawal of consent, physician decision or death.\n\n* End of Study (EOS)/Treatment Evaluation: At the time subjects are removed from study, laboratory and clinical evaluations will be performed.\n* Follow-up for Disease Progression:\n\n \\- Subjects who stop treatment prior to developing disease progression should be followed without further treatment until progressive disease is documented or until the treating physician feels additional treatment is required.\n* Follow-up for Survival:\n\n * Post study, subject survival status will be monitored on a monthly basis for 6 months from discontinuation from the study and every 3 months thereafter, until death or study termination in all subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Histologically or cytologically confirmed cutaneous BRAF wild-type malignant melanoma with evidence of metastasis (Stage IV).\n\n 2\\. No prior cytotoxic chemotherapy for metastatic malignant melanoma is permitted. No prior adjuvant cytotoxic chemotherapy is permitted.\n * Up to one prior regimen with the following classes of agents is permitted:\n\n o Targeted biologic agents (e.g. interleukin 2 \\[IL-2\\], granulocyte macrophage colony stimulating factor \\[GM-CSF\\], other cytokines or unarmed monoclonal antibodies)\n\n o Targeted small molecule inhibitors (e.g., kinase inhibitors, heat shock protein \\[HSP\\] inhibitors, etc.).\n * Immune checkpoint inhibitors (e.g. anti-CTLA4, anti-PD1, anti-PD-L1).\n * Prior adjuvant therapy with interferon and/or vaccines is permitted.\n * Prior treatments should be completed 4 weeks prior to enrollment in the study (ie, randomization).\n\n 3\\. Male or non-pregnant and non-lactating female, and ≥ 18 years of age at the time of signing the informed consent document.\n * If heterosexually active, the subject must agree to use medical doctor-approved contraception throughout the study, and for 6 months after last dose of study drug.\n\n 4\\. History of malignancy in the last 5 years; subjects with prior history of in situ cancer or basal or squamous cell skin cancer are eligible.\n * Subjects with other malignancies are eligible if they were cured by surgery (with or without radiotherapy) and have been continuously disease-free for at least 5 years.\n\n 5\\. Radiographically-documented measurable disease (defined by the presence of at least one radiographically documented measurable lesion including measurable cutaneous metastasis).\n\n 6\\. Adequate haemtological and biochemical parameters:\n * ANC ≥ 1.5 x 109 cells/L.\n * Platelets ≥ 100 x 109 cells/L.\n * Hgb ≥ 9 g/dL.\n * AST (SGOT) or ALT (SGPT) ≥ 2.5x upper limit of normal range (ULN);\n\n o ≤ 5.0 x ULN if hepatic metastases present.\n * Total bilirubin ≤ ULN. Creatinine ≤ 1.5 mg/dL. 8. ECOG performance status 0 to 1.\n\nExclusion Criteria:\n\n* 1\\. History of or current evidence of symptomatic brain metastases (brain Computed Tomography (CT)/Magnetic Resonance Imaging (MRI) is needed to exclude brain metastasis), including leptomeningeal involvement.\n\n 2\\. Subject has pre-existing peripheral neuropathy of National Cancer Institute NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Scale of Grade ≥ 2.\n\n 3\\. Prior radiation to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed.'}, 'identificationModule': {'nctId': 'NCT01933061', 'briefTitle': 'Study to Determine Efficacy and Safety of CC-486 With Nab-Paclitaxel Versus Nab-Paclitaxel in Patients With Chemotherapy naïve Metastatic Melanoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celgene'}, 'officialTitle': 'A Randomized, Open Label, Multi-center Phase 2 Study of Nab-Paclitaxel Versus Epigenetic Modifying Therapy of CC-4386 With Nab-Paclitaxel in Subjects With Chemotherapy naïve Metastatic Melanoma', 'orgStudyIdInfo': {'id': 'CC-486-MEL-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Abraxane 150 mg/m² Intravenous (IV)', 'interventionNames': ['Drug: Abraxane']}, {'type': 'EXPERIMENTAL', 'label': 'CC-486 orally plus Abraxane IV', 'interventionNames': ['Drug: Abraxane']}], 'interventions': [{'name': 'Abraxane', 'type': 'DRUG', 'otherNames': ['nab-paclitaxel, ABI-007'], 'description': 'Abraxane 150- mg/m² IV on Days 1, 8, and 15 of a 28-day cycle', 'armGroupLabels': ['Abraxane 150 mg/m² Intravenous (IV)']}, {'name': 'Abraxane', 'type': 'DRUG', 'otherNames': ['nab-paclitaxel, ABI-007'], 'description': 'Abraxane 150 mg/m\\^2 intravenously on Days 1, 8, and 15 of a 28-day cycle', 'armGroupLabels': ['CC-486 orally plus Abraxane IV']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kirsten Hege, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Celgene Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Celgene Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}