Expired Study
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Philadelphia, Pennsylvania 19107


Purpose:

Compassionate use of aldoxorubicin in sarcoma patients who have failed prior chemotherapy.


Study summary:

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.


Criteria:

Inclusion Criteria: - 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 - Must not be eligible for another CytRx-sponsored clinical trial - Able to provide complete medical records for review by the CytRx Medical Monitor - Able to receive treatment at a site that is participating or has participated in another CytRx-sponsored aldoxorubicin trial - Capable of providing informed consent and complying with trial procedures - ECOG performance status 0-2 - Measurable or evaluable tumor lesions according to RECIST 1.1 criteria - 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 - Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating Exclusion Criteria: - Chemotherapy, palliative surgery and/or radiation treatment less than 30 days prior to screening for non-target lesion - Exposure to any investigational agent within 30 days of screening - Central nervous system metastases that are symptomatic - 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 - Anion gap > 16 meq/L or arterial or venous blood pH < 7.30. - Clinically evident congestive heart failure > class II of the New York Heart Association (NYHA) guidelines - Current serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V - 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 - History or signs of active coronary artery disease with or without angina pectoris. - Serious myocardial dysfunction defined scintigraphically (eg MUGA, myocardial scintigram) or ultrasound determined absolute LVEF <45% of predicted - History of HIV infection - Active, clinically signifiant serious infection requiring treatment with antibiotics, anti-virals or anti-fungals - Major surgery within 3 weeks prior to enrollment - Substance abuse or any condition that might interfere with the subject's participation in the study or in the evaluation of the study results


NCT ID:

NCT02570412


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Philadelphia, Pennsylvania 19107
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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