Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2026-01-13 @ 9:21 PM
Study NCT ID:
NCT02570412
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2015-10-22
First Post:
2015-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compassionate Use of Aldoxorubicin in Sarcoma Patients Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C575867', 'term': 'DOXO-EMCH'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS'}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'statusVerifiedDate': '2015-10', 'lastUpdateSubmitDate': '2015-10-21', 'studyFirstSubmitDate': '2015-10-06', 'studyFirstSubmitQcDate': '2015-10-06', 'lastUpdatePostDateStruct': {'date': '2015-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-07', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Sarcoma']}, 'descriptionModule': {'briefSummary': 'Compassionate use of aldoxorubicin in sarcoma patients who have failed prior chemotherapy.', 'detailedDescription': 'This is a compassionate use protocol allowing sarcoma patients that have relapsed after prior therapies and are not eligible for other protocols involving the evaluation of aldoxorubicin to receive aldoxorubicin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Metastatic or unrectable sarcoma that has either relapsed or was refractory to at leat 1 prior chemotherapy or immunotherapy regimen and for which no standard approved therapy exists\n* Must not be eligible for another CytRx-sponsored clinical trial\n* Able to provide complete medical records for review by the CytRx Medical Monitor\n* Able to receive treatment at a site that is participating or has participated in another CytRx-sponsored aldoxorubicin trial\n* Capable of providing informed consent and complying with trial procedures\n* ECOG performance status 0-2\n* Measurable or evaluable tumor lesions according to RECIST 1.1 criteria\n* Women must not be able to become pregnant (eg post-menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study\n* Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating\n\nExclusion Criteria:\n\n* Chemotherapy, palliative surgery and/or radiation treatment less than 30 days prior to screening for non-target lesion\n* Exposure to any investigational agent within 30 days of screening\n* Central nervous system metastases that are symptomatic\n* Laboratory values: Screening serum creatinine \\>1.5×ULN, ALT \\>3×ULN, or \\>5×ULN if liver metastases are present, total bilirubin \\>3×ULN, ANC \\<1,500/mm3, platelet concentration \\<100,000/mm3, hematocrit level \\<25% for females or \\<27% for males, coagulation tests (PT, PTT, INR) \\>1.5×ULN\n* Anion gap \\> 16 meq/L or arterial or venous blood pH \\< 7.30.\n* Clinically evident congestive heart failure \\> class II of the New York Heart Association (NYHA) guidelines\n* Current serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V\n* Baseline QTc \\>470 msec and/or previous history of QT prolongation while taking other medications. Concomitant use of medications associated with a high incidence of QT prolongation is not allowed\n* History or signs of active coronary artery disease with or without angina pectoris.\n* Serious myocardial dysfunction defined scintigraphically (eg MUGA, myocardial scintigram) or ultrasound determined absolute LVEF \\<45% of predicted\n* History of HIV infection\n* Active, clinically signifiant serious infection requiring treatment with antibiotics, anti-virals or anti-fungals\n* Major surgery within 3 weeks prior to enrollment\n* Substance abuse or any condition that might interfere with the subject's participation in the study or in the evaluation of the study results"}, 'identificationModule': {'nctId': 'NCT02570412', 'briefTitle': 'Compassionate Use of Aldoxorubicin in Sarcoma Patients Chemotherapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'CytRx'}, 'officialTitle': 'Compassionate Use of Aldoxorubicin in Sarcoma Patients Who Have Failed Prior Chemotherapy', 'orgStudyIdInfo': {'id': 'Aldox Compassionate Use'}}, 'armsInterventionsModule': {'interventions': [{'name': 'aldoxorubicin', 'type': 'DRUG', 'description': 'aldoxorubicin administered at 350 mg/m2'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CytRx', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}