Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2026-01-24 @ 8:11 AM
Study NCT ID:
NCT01573468
Status:
UNKNOWN
Last Update Posted:
2012-07-24
First Post:
2012-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Capecitabine/Tesetaxel Versus Capecitabine/Placebo as Second-line Therapy for Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'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': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C479543', 'term': 'tesetaxel'}, {'id': 'D000069287', 'term': 'Capecitabine'}], 'ancestors': [{'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 580}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2014-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-07-20', 'studyFirstSubmitDate': '2012-04-05', 'studyFirstSubmitQcDate': '2012-04-06', 'lastUpdatePostDateStruct': {'date': '2012-07-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'When at least 508 events of death have occurred, which is estimated will occur 12 months after the date of randomization of the last patient'}], 'secondaryOutcomes': [{'measure': 'Disease control rate', 'timeFrame': 'Estimated will be assessed 12 months after the date of randomization of the last patient', 'description': 'The percentages of patients with complete or partial response of any duration or stable disease lasting at least 6 weeks from the date of randomization (revised RECIST)'}, {'measure': 'Progression-free survival', 'timeFrame': 'Estimated will be assessed 12 months after the date of randomization of the last patient', 'description': 'Calculated from the date of randomization to the date when disease progression is first documented or when the patient dies within 60 days of the last lesion assessment'}, {'measure': 'Response rate in patients with measurable disease', 'timeFrame': 'Estimated will be assessed 12 months after the date of randomization of the last patient', 'description': 'The percentages of patients with complete or partial response (revised RECIST)'}, {'measure': 'Incidence of adverse events', 'timeFrame': 'Through 30 days after the last dose of study medication', 'description': 'The percentages of patients who experience adverse events by specific adverse event term'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Gastric Carcinoma']}, 'descriptionModule': {'briefSummary': 'This study is being performed to evaluate the efficacy and safety of capecitabine in combination with tesetaxel versus capecitabine in combination with placebo as second-line treatment for patients with gastric cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key inclusion criteria:\n\n1. Histologically or cytologically confirmed gastric adenocarcinoma, including gastric or gastroesophageal-junction adenocarcinoma (Histologically confirmed adenocarcinoma of the lower esophagus acceptable with radiographic or endoscopic documentation of gastroesophageal-junction or proximal-stomach involvement.)\n2. Measurable disease (revised RECIST) based on computed tomography, or nonmeasurable disease\n3. ECOG performance status 0 or 1\n4. Treatment with only 1 prior regimen (as first-line therapy) that must have included a fluoropyrimidine and a platinum-containing agent (Prior adjuvant or neo-adjuvant chemotherapy acceptable provided 6 months elapsed between the end of this therapy and the start of first-line therapy.)\n5. Disease progression after the start of the 1 prior regimen based on computed tomography\n6. Adequate bone marrow, hepatic, and renal function\n7. Ability to swallow an oral solid-dosage form of medication\n\nKey exclusion criteria:\n\n1. Squamous cell gastric carcinoma\n2. Bone-only metastatic disease\n3. History or presence of brain metastasis or leptomeningeal disease\n4. Operable gastric or gastroesophageal-junction cancer\n5. HER2-positive disease if the patient has not previously been treated with an anti-HER2 agent\n6. Uncontrolled diarrhea, nausea, or vomiting\n7. Known malabsorptive disorder\n8. Significant medical disease other than gastric cancer\n9. Presence of neuropathy \\> Grade 1 (NCI Common Toxicity Criteria)\n10. Prior treatment (including adjuvant therapy) with a taxane or other tubulin-targeted agent (indibulin, eribulin, etc.)\n11. Prior radiation therapy to more than 25% of the bone marrow\n12. Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway\n13. Pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT01573468', 'acronym': 'TESEGAST', 'briefTitle': 'Capecitabine/Tesetaxel Versus Capecitabine/Placebo as Second-line Therapy for Gastric Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genta Incorporated'}, 'officialTitle': 'A Randomized, Double-blind Study of Capecitabine Plus Tesetaxel Versus Capecitabine Plus Placebo as Second-line Therapy in Subjects With Gastric Cancer', 'orgStudyIdInfo': {'id': 'TOG301'}, 'secondaryIdInfos': [{'id': '2010-022164-12', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Capecitabine-tesetaxel', 'description': '21-day cycle; tesetaxel 27 mg/m2 orally once on Day 1; capecitabine 1750 mg/m2/day orally in 2 equally divided doses on Days 1-14', 'interventionNames': ['Drug: Tesetaxel', 'Drug: Capecitabine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Capecitabine-placebo', 'description': '21-day cycle; placebo orally once on Day 1; capecitabine 1750 mg/m2/day orally in 2 equally divided doses on Days 1-14', 'interventionNames': ['Drug: Placebo', 'Drug: Capecitabine']}], 'interventions': [{'name': 'Tesetaxel', 'type': 'DRUG', 'description': 'Tesetaxel 27 mg/m2 orally once on Day 1 of each cycle', 'armGroupLabels': ['Capecitabine-tesetaxel']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo orally once on Day 1 of each cycle', 'armGroupLabels': ['Capecitabine-placebo']}, {'name': 'Capecitabine', 'type': 'DRUG', 'otherNames': ['Xeloda'], 'description': 'Capecitabine 1750 mg/m2/day orally twice daily (in 2 equally divided doses) on Days 1-14 of each cycle', 'armGroupLabels': ['Capecitabine-placebo', 'Capecitabine-tesetaxel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jaffer Ajani, MD', 'role': 'CONTACT', 'phone': '713-745-3917'}, {'name': 'Jaffer Ajani, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '60488', 'city': 'Frankfurt', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Salah-Eddin Al-Batran, PD Dr. med', 'role': 'CONTACT', 'phone': '+49 (0) 69 7601 4420'}, {'name': 'Salah-Eddin Al-Batran, PD Dr. med', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Krankenhaus Nordwest', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '704', 'city': 'Tainan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chia-Jui Yen, MD', 'role': 'CONTACT', 'phone': '+886 6 2353535 4620'}, {'name': 'Chia-Jui Yen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Cheng Kung University Hospital', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}], 'centralContacts': [{'name': 'Mansoor Ahmad, MD, PhD', 'role': 'CONTACT', 'email': 'medinfo@genta.com', 'phone': '908 286-3113'}], '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'}}}}