Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2026-01-02 @ 3:30 AM
Study NCT ID:
NCT02191761
Status:
COMPLETED
Last Update Posted:
2018-09-07
First Post:
2014-06-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Pharmacokinetics of SM04755 in Subjects With Advanced Colorectal, Gastric, Hepatic, or Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2015-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-05', 'studyFirstSubmitDate': '2014-06-30', 'studyFirstSubmitQcDate': '2014-07-14', 'lastUpdatePostDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the MTD', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'Incidence of safety parameters including adverse events, laboratory results, vital signs, electrocardiogram (ECG) findings, Eastern Cooperative Oncology Group (ECOG) performance scores, physical and ophthalmic examination findings', 'timeFrame': '28 days'}, {'measure': 'Area under the plasma concentration (AUC) Versus Time Curve of SM04755', 'timeFrame': '30 days'}, {'measure': 'Characterize the pharmacodynamics (PD) of SM04755 by assessment of its preliminary antitumor activity determined by Response Evaluation Criteria in Solid Tumors (RECIST)', 'timeFrame': '8 weeks'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of SM04755', 'timeFrame': '30 Days'}, {'measure': 'Half Life of SM04755', 'timeFrame': '30 Days'}, {'measure': 'Volume of Distribution of SM04755', 'timeFrame': '30 Days'}, {'measure': 'Time to maximum plasma concentration', 'timeFrame': '30 Days'}, {'measure': 'Accumulation ratio of SM04755', 'timeFrame': '30 Days'}, {'measure': 'Total Clearance of SM04755 after oral administration', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer', 'Gastric Cancer', 'Hepatic Cancer', 'Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'This is an open-label, multi-center, dose escalation study in adult subjects with advanced colorectal, gastric, hepatic or pancreatic cancer. The study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of SM04755 administered orally. Upon determination of the maximum tolerated dose (MTD), expansion cohorts may be enrolled.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with advanced colorectal, gastric, hepatic or pancreatic cancer\n* Subjects must have recovered from all toxicity associated with previous chemotherapy, targeted therapy, or radiotherapy\n* Subjects must meet certain laboratory criteria\n* Expected survival \\> 3months\n* Subjects must have no uncontrolled intercurrent illness\n\nExclusion Criteria:\n\n* Women who are pregnant or lactating, or who are of childbearing potential , and men who do not use a barrier method\n* Subjects with significant cardiac issues\n* Subjects using certain medications\n* Subjects with certain medical conditions\n* Subjects with brain metastasis\n* Subjects who have recently been enrolled in other experimental clinical trials of investigational agents'}, 'identificationModule': {'nctId': 'NCT02191761', 'briefTitle': 'Safety and Pharmacokinetics of SM04755 in Subjects With Advanced Colorectal, Gastric, Hepatic, or Pancreatic Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biosplice Therapeutics, Inc.'}, 'officialTitle': 'Phase1, Open-Label, Dose Escalation, Dose-Finding Study Evaluating the Safety and Pharmacokinetics of SM04755 in Subjects With Advanced Colorectal, Gastric, Hepatic, or Pancreatic Cancer', 'orgStudyIdInfo': {'id': 'SM04755-ONC-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SM04755', 'interventionNames': ['Drug: SM04755']}], 'interventions': [{'name': 'SM04755', 'type': 'DRUG', 'description': 'Escalating Doses', 'armGroupLabels': ['SM04755']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '92121', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biosplice Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}