- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02235701
Study to Investigate the Safety and Activity of Aldoxorubicin Plus Ifosfamide/Mesna in Subjects With Metastatic Soft Tissue Sarcoma
January 27, 2022 updated by: ImmunityBio, Inc.
An Open-Label Phase 1/2 Study to Investigate the Preliminary Safety and Activity of Aldoxorubicin Plus Ifosfamide/Mesna in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma
This is a Phase 1 open-label study to study the safety and activity of aldoxorubicin with ifosfamide/mesna in subjects with metastatic, advanced, unresectable soft tissue sarcoma.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Santa Monica, California, United States, 90403
- Sarcoma Oncology Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 80 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age between 15-80 years, male or female.
- Adjuvant or neoadjuvant chemotherapy (including doxorubicin) allowed if no tumor recurrence for at least 12 months since the last measurement, beginning or end of last chemotherapy.
- Histologically or cytologically confirmed, locally advanced, unresectable, and/or metastatic soft tissue sarcoma (including rhabdomyosarcoma, Ewing's sarcoma and mixed mesodermal sarcoma), chondrosarcoma or osteosarcoma of intermediate or high grade and gastrointestinal stromal tumors (GIST) (only in subjects that have progressed after receiving treatment with imatinib and sunitinib).
- Capable of providing informed consent and complying with trial procedures.
- ECOG performance status 0-2.
- Life expectancy >12 weeks.
- Measurable 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. (Adequate contraception includes: oral contraception, implanted contraception, intrauterine device implanted for at least 3 months, or barrier method in conjunction with spermicide.)
- Males and their female partner(s) of child-bearing potential must use 2 forms of effective contraception (see Inclusion 8 plus condom or vasectomy for males) from the last menstrual period of the female partner during the study treatment and for 6 months after the final dose of study treatment.
- Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating.
- Geographic accessibility to the site that ensures the subject will be able to keep all study-related appointments.
Exclusion Criteria:
- Prior chemotherapy unless for adjuvant or neoadjuvant therapy with no tumor recurrence for at least 12 months.
- Prior exposure to >3 cycles or 225 mg/m2 of doxorubicin or Doxil®.
- Palliative surgery and/or radiation treatment less than 30 days prior to enrollment.
- Exposure to any investigational agent within 30 days of enrollment.
- Current Stage 1 or 2 soft tissue sarcomas.
- Current evidence/diagnosis of alveolar soft part sarcoma, dermatofibrosarcoma, Kaposi's sarcoma, clear cell sarcomas and unresectable low grade liposarcomas.
- Central nervous system metastasis if symptomatic.
- History of other malignancies except cured basal cell carcinoma, superficial bladder cancer or carcinoma in situ of the cervix unless documented free of cancer for ≥ 5 years.
- Laboratory values: Screening serum creatinine >1.5x upper limit of normal (ULN), alanine aminotransferase (ALT) > 3 × ULN or >5 × ULN if liver metastases are present, total bilirubin >3 × ULN, absolute neutrophil count <1,500/mm3, platelet concentration <100,000/mm3, hematocrit level <25% for females or <27% for males, albumin <2 gm/dL, coagulation tests (prothrombin time [PT], partial thromboplastin time [PTT], International Normalized Ratio [INR]) >1.5 × ULN.
- Clinically evident congestive heart failure > class II of the New York Heart Association (NYHA) guidelines.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: aldoxorubicin
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administered at 170 mg/m2 plus 1 gm/m2/day ifosfamide by continuous intravenous infusion for up to 14 days on Day 1 every 28 days
Other Names:
administered at 250 mg/m2 plus 1 gm/m2/day ifosfamide by continuous intravenous infusion for up to 14 days on Day 1 every 28 days
Other Names:
administered 350 mg/m2 plus 1 gm/m2/day ifosfamide by continuous intravenous infusion for up to 14 days on Day 1 every 28 days
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety Measures
Time Frame: 14 months
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The primary objective of this study is to determine the preliminary safety of administration of aldoxorubicin in combination with ifosfamide in subjects with metastatic, locally advanced, or unresectable soft tissue sarcoma as measured by the frequency and severity of adverse events (AEs), abnormal findings on physical examination, laboratory tests, vital signs, echocardiograms (ECHO) or multiple-gated acquisition (MUGA) scans, electrocardiogram (ECG) results, and weight.
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14 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumor Response
Time Frame: 17 months
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The secondary objective of this study is to evaluate the activity of aldoxorubicin in combination with ifosfamide/mesna in this population, assessed by overall response rate and progression-free survival (PFS).
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17 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Dan Levitt, M.D., CytRx Coporation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 2, 2014
Primary Completion (Actual)
May 1, 2018
Study Completion (Actual)
May 1, 2018
Study Registration Dates
First Submitted
August 15, 2014
First Submitted That Met QC Criteria
September 8, 2014
First Posted (Estimate)
September 10, 2014
Study Record Updates
Last Update Posted (Actual)
February 10, 2022
Last Update Submitted That Met QC Criteria
January 27, 2022
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Sarcoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Ifosfamide
- Doxorubicin
Other Study ID Numbers
- ALDOXORUBICIN-P1/2-STS-03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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