Compassionate Use of Aldoxorubicin in Sarcoma Patients Chemotherapy

CytRx

Status

Conditions: Sarcoma

Treatments: Drug: aldoxorubicin

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT02570412

Aldox Compassionate Use

Details and patient eligibility

About

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

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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