Compassionate Use of Aldoxorubicin in Sarcoma Patients Chemotherapy

NCT02570412 | Unknown

• 1 other identifier: Aldox Compassionate Use
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sarcoma

Interventions

aldoxorubicin DRUG

aldoxorubicin administered at 350 mg/m2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CytRx: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Sarcoma

Interventions

DOXO-EMCH

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2015
• First Posted: October 7, 2015
• Last Updated: October 22, 2015

Record last verified: 2015-10

Locations

US (1)