Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-31 @ 4:04 AM
Study NCT ID:
NCT05566834
Status:
UNKNOWN
Last Update Posted:
2023-10-18
First Post:
2022-09-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Minnelide™ Capsules Alone and in Combination With Paclitaxel in Advanced 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': 'C579022', 'term': '14-O-phosphonooxymethyltriptolide disodium salt'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Minnelide™ is a water soluble disodium salt variant of triptolide, a diterpenoid, an HSP70 inhibitor. Studies using orthotopic pancreatic cancer cell lines and human xenograft transplants demonstrate that Minnelide™ prevents tumor progression, increases survival, and causes tumor regression.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-17', 'studyFirstSubmitDate': '2022-09-22', 'studyFirstSubmitQcDate': '2022-09-30', 'lastUpdatePostDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine any increase of treatment emergent adverse events when Minnelide capsules are given in combination with paclitaxel.', 'timeFrame': '24 months', 'description': 'To observe any increase in the number of patients that experience Grade 4 neutropenia lasting ≥ 5 days or Grade 3 or 4 neutropenia with fever and/or infection; Grade 4 thrombocytopenia (or Grade 3 with bleeding); Grade 3 or 4 treatment-related non-hematological toxicity (Grade 3 nausea, vomiting or diarrhea that last \\> 72 hours despite maximal treatment when Minnelide is given alone and in combination with paclitaxel compared to the incidence with gemcitabine and nab-paclitaxel.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics of Minnelide when given with paclitaxel', 'timeFrame': '24 months', 'description': 'Area under the concentration curve (AUC) will be determine the exposure of Minnelide'}, {'measure': 'Plasma levels of Minnelide when given with paclitaxel', 'timeFrame': '24 months', 'description': 'Maximum plasma concentration (Cmax) will be measured to determine the effect of Minnelide when given with paclitaxel'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gastric Cancer'], 'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'A Phase 1, Open-label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of Minnelide™ Capsules given alone or in combination with paclitaxel in patients with Advanced Gastric Cancer.', 'detailedDescription': 'Minnelide™ is a water soluble disodium salt variant of triptolide, a diterpenoid, an HSP70 inhibitor. Studies using orthotopic pancreatic cancer cell lines and human xenograft transplants demonstrate that Minnelide™ prevents tumor progression, increases survival, and causes tumor regression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with histologically confirmed advanced gastric cancer\n\n * Tumor progression after receiving standard/approved chemotherapy or where there is no approved therapy\n * One or more metastatic tumors measurable per RECIST v1.1 Criteria\n * Karnofsky performance ≥ 70%\n * Life expectancy of at least 3 months\n * Age ³ 19 years\n * Signed, written IRB-approved informed consent\n * A negative pregnancy test (if female)\n * Acceptable liver function:\n\n * Bilirubin 1.5 times upper limit of normal\n * AST (SGOT), ALT (SGPT) and Alkaline phosphatase 2.5 times upper limit of normal (if liver metastases are present, then 5 x ULN is allowed)\n * Albumin ≥ 3.0 g/dL\n * Acceptable renal function:\n\n o Serum creatinine within normal limits, OR calculated creatinine clearance ³ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.\n * Acceptable hematologic status:\n\n * Granulocyte\n\n * Monotherapy: ³ 1,500 cells/mm3\n * Combination therapy with paclitaxel: ³ 2,000cells/mm3 Platelet count ³ 100,000 (plt/mm3)\n * Hemoglobin ³ 9 g/dL\n * Urinalysis:\n\n o No clinically significant abnormalities\n * Acceptable coagulation status:\n\n * PT ≤ 1.5 times institutional ULN\n * PTT ≤ 1.5 times institutional ULN\n * Women of child- bearing potential and men must agree to use adequate contraception For men and women of child-producing potential, the use of effective contraceptive methods during the study and until 90 days after the last dose of IP for men or until 6 months after the last dose of IP for women or 6 months after the last dose of IP with paclitaxel for both men and women.\n\nExclusion Criteria:\n\nNew York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG\n\n* Baseline QTc exceeding 470 msec (using the Bazett's formula) and/or patients receiving class 1A or class III antiarrhythmic agents.\n* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.\n* Pregnant or nursing women. NOTE: For men and women of child-producing potential, the use of effective contraceptive methods during the study and until 90 days after the last dose of IP for men or until 6 months after the last dose of IP for women or 6 months after the last dose of IP with paclitaxel for both men and women. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n* Treatment with radiation therapy (local therapy, non-target lesion, 2 weeks), major surgery, chemotherapy, biological agents or investigational therapy within 3 weeks prior to study treatment.\n* Unwillingness or inability to comply with procedures required in this protocol\n* Known infection with HIV, hepatitis B, or hepatitis C\n* Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor\n* Patients who are currently receiving any other investigational agent\n* Patients who are on a prohibited medication (section 4.3.2).\n* Patients with biliary obstruction and/or biliary stent (Regimen B only)\n* Patients with a history of severe hypersensitivity reactions to products containing Cremophor® EL (eg, cyclosporin for injection concentrate and teniposide for injection concentrate). • Patient with baseline ANC\\<1500/mm3"}, 'identificationModule': {'nctId': 'NCT05566834', 'briefTitle': 'Minnelide™ Capsules Alone and in Combination With Paclitaxel in Advanced Gastric Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Minneamrita Therapeutics LLC'}, 'officialTitle': 'A Phase 1 Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Minnelide™ Capsules Given Alone or in Combination With Paclitaxel in Patients With Advanced Gastric Cancer', 'orgStudyIdInfo': {'id': 'Minnelide GC 101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open-label, dose-escalation, safety, Pharmacodynamic, pharmacokinetic study.', 'description': 'One', 'interventionNames': ['Drug: Minnelide']}], 'interventions': [{'name': 'Minnelide', 'type': 'DRUG', 'description': 'at the MTD dose level established for monotherapy or combination to confirm safety. With a sample of 12 patients, the probability is \\> 80% that a serious adverse event with at least a 16% incidence will be detected.', 'armGroupLabels': ['Open-label, dose-escalation, safety, Pharmacodynamic, pharmacokinetic study.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Soeul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'EUNKYUNG Park, RN', 'role': 'CONTACT', 'email': 'ekek.park@samsung.com', 'phone': '+82-2-2008-4390'}, {'name': 'Jeeyun Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 36.9168, 'lon': 126.7319}}], 'centralContacts': [{'name': 'Mohana Velagapudi, MD', 'role': 'CONTACT', 'email': 'mvelagapudi@minneamrita.com', 'phone': '3092693132'}], 'overallOfficials': [{'name': 'Mohana Velagapudi', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Minneamrita Therapeutics LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minneamrita Therapeutics LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}