Study Overview

Details

NCTId: NCT02570412

Status: No longer available

Condition: Sarcoma

Study Type: Expanded Access

Sponsor: CytRx

Study Description

Brief

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

Detailed

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.

Eligibility

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 1.5×ULN
Anion gap > 16 meq/L or arterial or venous blood pH 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

Gender: All

Min Age: 18 Years

Contacts

Thomas Jefferson University

Philadelphia

Pennsylvania

19107

United States