Compassionate Use of Aldoxorubicin in Sarcoma Patients Chemotherapy
Primary Purpose
Sarcoma
Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
aldoxorubicin
Sponsored by
About this trial
This is an expanded access trial for Sarcoma
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
Sites / Locations
- Thomas Jefferson University
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02570412
Brief Title
Compassionate Use of Aldoxorubicin in Sarcoma Patients Chemotherapy
Official Title
Compassionate Use of Aldoxorubicin in Sarcoma Patients Who Have Failed Prior Chemotherapy
Study Type
Expanded Access
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CytRx
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
aldoxorubicin
Intervention Description
aldoxorubicin administered at 350 mg/m2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
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
Facility Information:
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Compassionate Use of Aldoxorubicin in Sarcoma Patients Chemotherapy
We'll reach out to this number within 24 hrs