Ignite Creation Date:
2025-12-26 @ 11:11 PM
Ignite Modification Date:
2025-12-26 @ 11:11 PM
Study NCT ID:
NCT04615312
Status:
UNKNOWN
Last Update Posted:
2021-08-23
First Post:
2020-10-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Trail of CDK4 / 6 Inhibitor and MEK Inhibitor in the Treatment of Metastatic Digestive System Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-20', 'studyFirstSubmitDate': '2020-10-29', 'studyFirstSubmitQcDate': '2020-10-29', 'lastUpdatePostDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the maximum tolerated dose of a CDK4 / 6 inhibitor and a MEK inhibitor therapy', 'timeFrame': 'Up to approximately 24 months'}], 'secondaryOutcomes': [{'measure': 'ORR', 'timeFrame': 'Up to approximately 24 months', 'description': 'the Objective Remission Rate'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Digestive System Tumors']}, 'descriptionModule': {'briefSummary': 'This is a prospective, open, phase I clinical study to evaluate the safety and tolerability of a CDK4 / 6 inhibitor and a MEK inhibitor in the treatment of metastatic digestive system tumors'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 18-75 years;\n2. ECOG score ≤ 1;\n3. Patients with advanced KRAS mutation or metastatic digestive system tumor confirmed by histology or cytology and imaging diagnosis;\n4. According to Recist1.1, there was at least one measurable lesion;\n5. The expected survival time was more than 12 weeks;\n\nExclusion Criteria:\n\n1. Patients who received any anti-tumor treatment within 4 weeks before enrollment, including radiotherapy, chemotherapy, molecular targeted therapy and immunotherapy, or participated in another intervention clinical trial;\n2. Previous treatment with targeted BRAF, MEK, ERK or CDK family related inhibitors;\n3. The third space effusion (such as massive pleural effusion or ascites) with clinical symptoms that cannot be controlled by drainage or other methods;\n4. Allergy to any test drug and its excipients, or serious allergic history, or contraindication of the test drug;\n5. Have a history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation;'}, 'identificationModule': {'nctId': 'NCT04615312', 'briefTitle': 'A Trail of CDK4 / 6 Inhibitor and MEK Inhibitor in the Treatment of Metastatic Digestive System Tumors', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Henan Cancer Hospital'}, 'officialTitle': 'Phase I Clinical Study on the Safety and Tolerability of a CDK4 / 6 Inhibitor and a MEK Inhibitor in the Treatment of Metastatic Digestive System Tumors', 'orgStudyIdInfo': {'id': 'CRC-PANC-IIT-SHR6390-SHR7390'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'a CDK4 / 6 inhibitor and a MEK inhibitor', 'description': 'Participants will receive a CDK4 / 6 inhibitor and a MEK inhibitor treatment', 'interventionNames': ['Drug: a CDK4 / 6 inhibitor and a MEK inhibitor']}], 'interventions': [{'name': 'a CDK4 / 6 inhibitor and a MEK inhibitor', 'type': 'DRUG', 'description': 'Participant will receive a CDK4 / 6 inhibitor and a MEK inhibitor treatment to determine the maximum tolerated dose', 'armGroupLabels': ['a CDK4 / 6 inhibitor and a MEK inhibitor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '450008', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ning Li, PhD', 'role': 'CONTACT', 'email': 'lining97@126.com', 'phone': '0086-13526501903'}, {'name': 'Ning Li, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Suxia Luo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Henan Cancer Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'Ning Li, PhD', 'role': 'CONTACT', 'email': 'lining97@126.com', 'phone': '13526501903'}], 'overallOfficials': [{'name': 'Ning Li, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Henan Cancer Hospital'}, {'name': 'Suxia Luo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Henan Cancer Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henan Cancer Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Physician', 'investigatorFullName': 'LiNing', 'investigatorAffiliation': 'Henan Cancer Hospital'}}}}