Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT01095120
Status:
UNKNOWN
Last Update Posted:
2012-03-15
First Post:
2010-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tesetaxel as Second-line Therapy for Patients With Advanced Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C479543', 'term': 'tesetaxel'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 27}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2012-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-03-14', 'studyFirstSubmitDate': '2010-03-26', 'studyFirstSubmitQcDate': '2010-03-26', 'lastUpdatePostDateStruct': {'date': '2012-03-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate (Response Evaluation Criteria In Solid Tumors (RECIST))', 'timeFrame': '12 months from date of first dose of study medication'}], 'secondaryOutcomes': [{'measure': 'Disease control rate (ie, the percentage of patients with a confirmed complete or partial response [of any duration] or stable disease at least 6 weeks in duration)', 'timeFrame': '12 months from date of first dose of study medication'}, {'measure': 'Durable response rate (ie, the proportion of patients with a confirmed complete or partial response at least 6 months in duration)', 'timeFrame': '12 months from date of first dose of study medication'}, {'measure': 'Duration of response', 'timeFrame': '12 months from date of first dose of study medication'}, {'measure': 'Adverse events', 'timeFrame': 'Through 30 days post last dose of study medication'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Adenocarcinoma of the Stomach', 'Adenocarcinoma of Esophagogastric Junction']}, 'descriptionModule': {'briefSummary': 'Tesetaxel is an orally administered chemotherapy agent of the taxane class. This study is being undertaken to evaluate the efficacy and safety of tesetaxel administered as second-line therapy to patients with advanced gastric cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Primary inclusion criteria:\n\n* Confirmed diagnosis of adenocarcinoma of the stomach or esophagogastric junction\n* Measurable disease (revised RECIST; Version 1.1) based on computed tomography\n* Eastern Cooperative Oncology Group performance status 0 or 1\n* Treatment with only 1 prior regimen (as first-line therapy) and that regimen included a fluoropyrimidine and/or a platinum analogue\n* Documented disease progression within 4 months of the last dose of the 1 prior regimen\n* Adequate bone marrow, hepatic, and renal function, as defined in the protocol\n* At least 4 weeks and recovery from effects of prior surgery or other therapy, including immunotherapy, radiation therapy, or cytokine, biologic or vaccine therapy, with an approved or investigational agent\n* Ability to swallow an oral solid-dosage form of medication\n\nPrimary exclusion criteria:\n\n* Nonmeasurable disease only (revised RECIST; Version 1.1)\n* History or presence of brain metastasis or leptomeningeal disease\n* Operable gastric cancer or operable cancer of the esophagogastric junction\n* Uncontrolled diarrhea, defined as more than 3 loose bowel movements above the patient's usual number of bowel movements on at least 2 days within the 14 days prior to enrollment\n* Uncontrolled nausea or vomiting within the 14 days prior to enrollment despite the administration of standard antiemetic therapy\n* Known malabsorptive disorder\n* Significant medical disease other than cancer, as defined in the protocol\n* Presence of neuropathy \\> Grade 1 (National Cancer Institute Common Toxicity Criteria \\[NCI CTC\\]; Version 4.0)\n* Prior treatment with a taxane or other tubulin-targeted agent (eg, indibulin) other than a vinca alkaloid\n* Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity"}, 'identificationModule': {'nctId': 'NCT01095120', 'briefTitle': 'Tesetaxel as Second-line Therapy for Patients With Advanced Gastric Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genta Incorporated'}, 'officialTitle': 'A Phase II Study of Tesetaxel Administered at a Flat Dose Once Every 21 Days as Second-line Therapy to Subjects With Advanced Gastric Cancer', 'orgStudyIdInfo': {'id': 'TOG201'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tesetaxel', 'type': 'DRUG', 'otherNames': ['DJ-927'], 'description': 'For subjects in Cohort A, a flat dose of 40 mg will be administered in Cycle 1; the dose will be adjusted based on body weight. In subsequent cycles, depending on tolerability, the Cycle 1 flat dose may be increased by 5 mg in Cycle 2, and the Cycle 2 flat dose may again be increased by 5 mg in Cycle 3.\n\nFor subjects in Cohort B, a flat dose of 50 mg will be administered in Cycle 1; the dose will be adjusted based on body weight. In subsequent cycles, depending on tolerability, the dose may be increased by 10 mg in Cycle 2.\n\nFor subjects in Cohort C, a dose of 27 mg/m2 will be administered in Cycle 1. In subsequent cycles, depending on tolerability, the dose will be increased to 35 mg/m2 in Cycle 2.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Medical Faculty Foundation', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abramson Cancer of the University of Pennsylvania at Perelman Center for Advanced Medicine', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texax MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital, Yonsei University Health System', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jaffer Ajani, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'The University of Texas MD Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genta Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}