Compassionate Use of Aldoxorubicin in Sarcoma Patients Chemotherapy

NCT ID: NCT02570412

Last Updated: 2015-10-22

Basic Information

• Recruitment Status: NO_LONGER_AVAILABLE
• Study Classification: EXPANDED_ACCESS

Brief Summary

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

Detailed 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.

Conditions

Sarcoma

Interventions

aldoxorubicin

aldoxorubicin administered at 350 mg/m2

Intervention Type: DRUG

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 <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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CytRx

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

Aldox Compassionate Use

Identifier Type: -

Identifier Source: org_study_id