Compassionate Use of Aldoxorubicin in Sarcoma Patients Chemotherapy

Sarcoma Clinical Trial

Official title:

Compassionate Use of Aldoxorubicin in Sarcoma Patients Who Have Failed Prior Chemotherapy

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT02570412
• Other study ID #: Aldox Compassionate Use
• Status: No longer available
• Phase: N/A
• First received: October 6, 2015
• Last updated: October 21, 2015

Study information

• Verified date: October 2015
• Source: CytRx
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Expanded Access

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Sarcoma

Intervention

Drug:
• aldoxorubicin
aldoxorubicin administered at 350 mg/m2

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
CytRx

Country where clinical trial is conducted

United States,