SarcomaNCT02570412
Compassionate Use of Aldoxorubicin in Sarcoma Patients Chemotherapy
A study testing aldoxorubicin in people with Sarcoma, run by CytRx at 1 site in United States.
Trial summary
Compassionate use of aldoxorubicin in sarcoma patients who have failed prior chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma
- What is being tested?
- aldoxorubicin
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Compassionate Use of Aldoxorubicin in Sarcoma Patients Who Have Failed Prior Chemotherapy
Compassionate use of aldoxorubicin in sarcoma patients who have failed prior chemotherapy.
Read the 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
- Being tested
- aldoxorubicin
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aldoxorubicinDrug
aldoxorubicin administered at 350 mg/m2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- CytRx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02570412
- Sponsor's protocol ID
- Aldox Compassionate Use
- Status last verified
- Oct 2015
- First submitted
- 6 Oct 2015
- Last updated
- 22 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compassionate Use of Aldoxorubicin in Sarcoma Patients Who Have Failed Prior Chemotherapy
- ClinicalTrials.gov ID
- NCT02570412
- Acronym / sponsor ID
- Aldox Compassionate Use
- Conditions
- Sarcoma
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- CytRxIndustry (pharma, biotech, devices)
- First posted
- 7 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aldoxorubicinaldoxorubicin administered at 350 mg/m2 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aldoxorubicin in people with Sarcoma, run by CytRx at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2015.