Metastatic, Locally Advanced, or Unresectable Soft Tissue SarcomaPhase 1/2NCT02235701
Study to Investigate the Safety and Activity of Aldoxorubicin Plus Ifosfamide/Mesna in Subjects With Metastatic Soft Tissue Sarcoma
A Phase 1/2 study testing 170 mg/m2 aldoxorubicin and 250 mg/m2 aldoxorubicin in people with Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma, run by ImmunityBio, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma
- What is being tested?
- 170 mg/m2 aldoxorubicin and 250 mg/m2 aldoxorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2014to 1 May 2018
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sarcoma Oncology Center
Santa Monica, California, 90403
About this study
Official title: 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.
- Being tested
- 170 mg/m2 aldoxorubicin, 250 mg/m2 aldoxorubicin
- Keywords
- soft tissue sarcoma, aldoxorubicin, ifosfamide, mesna, phase 1, INNO-206
- Medical subject headings
- Neoplasm Metastasis, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
170 mg/m2 aldoxorubicinDrug
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
250 mg/m2 aldoxorubicinDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 170 mg/m2 aldoxorubicin | Experimental | Not described Receives: Drug: 170 mg/m2 aldoxorubicin |
| 250 mg/m2 aldoxorubicin | Experimental | Not described Receives: Drug: 250 mg/m2 aldoxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events in Participants
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).
The following assessments were used to determine if subjects had adverse events:
- vitals signs (systolic/diastolic blood pressure, pulse, respiration, temperature, weight, and body surface area)
- physical examination
- laboratory tests (chemistry, hematology, urinalysis, anion gap) additionally, the following scans were performed to determine adverse events:
- ECHO / MUGA
- ECG
Measured: Treatment was planned to continue until tumor progression is observed, subject asks to withdraw, or unacceptable toxicity occurs (up to 766 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study start2 Sep 2014
- Primary completion1 May 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic, Locally Advanced, or Unresectable Soft Tissue SarcomaStudies of the same condition, open and under way.
- More trials run by ImmunityBio, Inc.The sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImmunityBio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dan Levitt, M.D., Study director, CytRx Coporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235701
- Sponsor's protocol ID
- ALDOXORUBICIN-P1/2-STS-03
- Status last verified
- Oct 2016
- First submitted
- 15 Aug 2014
- Last updated
- 29 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02235701
- Acronym / sponsor ID
- ALDOXORUBICIN-P1/2-STS-03
- Keywords
- soft tissue sarcoma, aldoxorubicin, ifosfamide, mesna, phase 1, INNO-206
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- ImmunityBio, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Sep 2014 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 10 Sep 2014 (estimated)
- Results
- Posted 29 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 170 mg/m2 aldoxorubicin | Experimental | Drug: 170 mg/m2 aldoxorubicin |
| 250 mg/m2 aldoxorubicin | Experimental | Drug: 250 mg/m2 aldoxorubicin |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
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 |
|---|---|---|
| 170 mg/m2 aldoxorubicinadministered 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 | Drug | 170 mg/m2 aldoxorubicin |
| 250 mg/m2 aldoxorubicinadministered 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 | Drug | 250 mg/m2 aldoxorubicin |
Primary outcome
Number of Adverse Events in Participants
Time frame: Treatment was planned to continue until tumor progression is observed, subject asks to withdraw, or unacceptable toxicity occurs (up to 766 days).
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). The following assessments were used to determine if subjects had adverse events: * vitals signs (systolic/diastolic blood pressure, pulse, respiration, temperature, weight, and body surface area) * physical examination * laboratory tests (chemistry, hematology, urinalysis, anion gap) additionally, the following scans were performed to determine adverse events: * ECHO / MUGA * ECG
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
Related trials for Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma
Active, not recruitingPhase 2
Testing Ipilimumab and Nivolumab Combination With or Without Cabozantinib in People >= 18 Years Old With Advanced Soft Tissue Sarcoma
Locally Advanced Extraskeletal Myxoid Chondrosarcoma, Locally Advanced Leiomyosarcoma
RecruitingPhase 2
Atezolizumab and Cabozantinib for the Treatment of Adolescents and Young Adults With Recurrent or Metastatic Osteosarcoma, TACOS Study
Locally Advanced Osteosarcoma, Metastatic Osteosarcoma
RecruitingPhase 1
A Study to Evaluate Safety, Tolerability and Preliminary Activity of AGX101 in Participants With Advanced Solid Tumors
Cancer, Advanced Cancer
RecruitingPhase 1/2
Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Active, not recruitingEarly Phase 1
Gemcitabine Plus Ascorbate for Sarcoma in Adults (Pilot)
Sarcoma, Soft Tissue Sarcoma
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.
Dan Levitt, M.D. study director
CytRx Coporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 170 mg/m2 aldoxorubicin and 250 mg/m2 aldoxorubicin in people with Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma, run by ImmunityBio, Inc. 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 11 inclusion and 10 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: finished, as of the sponsor's last update on 29 May 2024. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Number of Adverse Events in Participants (time frame: Treatment was planned to continue until tumor progression is observed, subject asks to withdraw, or unacceptable toxicity occurs (up to 766 days).). It is what the study was designed to measure, not a finding.
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 29 May 2024.