Metastatic, Locally Advanced or Unresectable Soft Tissue SarcomaPhase 3NCT02049905
Phase 3 Study to Treat Patients With Soft Tissue Sarcomas
A Phase 3 study testing Aldoxorubicin and Investigator's Choice Treatment (Darcabazine, Pazopanib, Gemcitabine + Docetaxel, Doxorubicin, Ifosfamide) in people with Metastatic, Locally Advanced or Unresectable Soft Tissue Sarcoma, run by ImmunityBio, Inc. at 74 sites in 13 countries.
Trial summary
The purpose of this study is to determine the efficacy and safety of aldoxorubicin in subjects with metastatic, locally advanced, or unresectable soft tissue sarcomas. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Metastatic, Locally Advanced or Unresectable Soft Tissue Sarcoma
- What is being tested?
- Aldoxorubicin and Investigator's Choice Treatment (Darcabazine, Pazopanib, Gemcitabine + Docetaxel, Doxorubicin, Ifosfamide)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 433 participants
- Where
- 74 sitesin 13 countries
- Study dates
- Jan 2014to May 2017
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Has provided written informed consent prior to any study related activities.
- Age ≥15 years (US only), and 18-80 (rest of world (ROW)), male or female.
- Histological confirmation of intermediate or high grade soft-tissue sarcoma. Tissue must be sent to a central pathology lab for review but will not preclude entry onto the study. Final assignment of tumor grade and histology will be based on the designation provided by the central pathology review.
- An adequate tumor specimen obtained by either excisional biopsy, incisional biopsy or core needle biopsy must be sent to the central pathology lab for evaluation. The material must measure at least 0.8 × 0.1 cm in size or contain at least 50 tumor cells.
- Locally advanced, unresectable, and/or metastatic soft-tissue sarcoma of intermediate or high grade with evidence of disease progression by either computed tomography (CT) or magnetic resonance imaging (MRI) scan, or clinical judgment on or after the last cancer therapy within 6 months prior to randomization.
- Relapsed or refractory (lack of response) to ≥1 course of systemic therapy regimen(s), excluding adjuvant or neoadjuvant chemotherapy, and is incurable by either surgery or radiation.
Show all 14Show fewer
- Capable of providing informed consent and complying with trial procedures.
- ECOG PS 0-2.
- Life expectancy >12 weeks.
- Measurable tumor lesions according to RECIST 1.1 criteria.[50]
- Women must not be able to become pregnant (e.g., 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 11 plus condom or vasectomy for males) from the last menstrual period of the female partner during the study treatment and agree to continue use 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.
- Accessibility to the site that optimizes the subject's ability to keep all study-related appointments.
Who cannot join
- Prior exposure to >375 mg/m2 of doxorubicin or liposomal doxorubicin.
- Palliative surgery and/or radiation treatment within 30 days prior to date of randomization.
- Exposure to any investigational agent within 30 days of date of randomization.
- Exposure to any systemic chemotherapy within 30 days of date of randomization.
- An inadequate tumor specimen as defined by the central pathologist.
- Current evidence/diagnosis of alveolar soft part sarcoma, extraskeletal myxoid chondrosarcoma, rhabdomyosarcoma, osteosarcoma, gastrointestinal stromal tumor (GIST), dermatofibrosarcoma (unless transformed to fibrosarcoma), Ewing's sarcoma, Kaposi's sarcoma, mixed mesodermal tumor, clear cell sarcomas.
Show all 20Show fewer
- Evidence of central nervous system (CNS) metastasis who have not received prior definitive therapy for their lesions.
- History of other malignancies except cured basal cell carcinoma, cutaneous squamous cell carcinoma, melanoma in situ, superficial bladder cancer or carcinoma in situ of the cervix unless documented free of cancer for ≥5 years.
- Laboratory values: Screening serum creatinine >1.5 x upper limit of normal (ULN), alanine aminotransferase (ALT) >3×ULN or >5×ULN if liver metastases are present, total bilirubin >2×ULN, absolute neutrophil count (ANC) <1,500/mm3, platelet concentration <100,000/mm3, hemoglobin <9g/dL.
- Clinically evident congestive heart failure (CHF) > 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 within the last 6 months.
- Serious myocardial dysfunction defined by ECHO as absolute left ventricular ejection fraction (LVEF) below the institution's lower limit of predicted normal.
- Known history of HIV infection.
- Active, clinically significant serious infection requiring treatment with antibiotics, anti-virals or anti-fungals. The Medical Monitor should be contacted for any uncertainties.
- Major surgery within 30 days prior to date of randomization.
- Current or past substance abuse or any condition that might interfere with the subject's participation in the study or in the evaluation of the study results.
- Any condition that is unstable and could jeopardize the subject's participation in the study.
Trial locations and contacts
74 sites in 13 countries.
74 sites in 13 countries
United States36 sites
University of Michigan
Ann Arbor, Michigan, 48109
Georgia Cancer Specialists
Atlanta, Georgia, 30341
U of CO Health Sciences Center
Aurora, Colorado, 80045
University of Alabama at Birmingham
Birmingham, Alabama, 35243
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Roswell Park Cancer Institute
Buffalo, New York, 14263
Fletcher Allen Health Care
Burlington, Vermont, 05405
Levine Cancer Institute
Charlotte, North Carolina, 28204
Northwestern Medical Faculty Foundation
Chicago, Illinois, 60611
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
Cleveland Clinic
Cleveland, Ohio, 44195
The James Cancer Hospital and Solove Research Institute
Columbus, Ohio, 43202
Rocky Mountain Cancer Centers
Denver, Colorado, 80218
City of Hope Medical Group
Duarte, California, 91010
Mayo Clinic
Jacksonville, Florida, 32224
Samuel Oschin Cancer Center
Los Angeles, California, 90048
UCLA Medical Center
Los Angeles, California, 90095
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of Minnesota
Minneapolis, Minnesota, 55455
Edward Cancer Center
Naperville, Illinois, 60540
Vanderbilt University
Nashville, Tennessee, 37212
Oncology Specialists, SC
Niles, Illinois, 60714
Nebraska Methodist Hospital
Omaha, Nebraska, 68114
Kansas City Cancer Center
Overland Park, Kansas, 66210
Jefferson Medical College
Philadelphia, Pennsylvania, 19107
Arizona Oncology Associates, PC
Phoenix, Arizona, 85016
U of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15232
Center for Health and Healing
Portland, Oregon, 97239
Mayo Clinic
Rochester, Minnesota, 55905
Sarcoma Oncology Center
Santa Monica, California, 940403
Washington University
St Louis, Missouri, 63110
Stanford University Medical Center
Stanford, California, 94305
Moffitt Cancer Center
Tampa, Florida, 33612
The University of Arizona
Tucson, Arizona, 85719
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
Spain10 sites
Hospital Santa Creu i Sant Pau
Barcelona, 08025
Inst Catala D'Oncologia
Barcelona
Consorcio Hospitalario Provincial de Castellon
Castellon, Castellon
Hospital Universitario La Paz
Madrid, 28046
Centro Integral Oncologico Clara Campal, Hospital de Madrid Norte-San Chinarro
Madrid
Hospital San Carlos Madrid
Madrid
Hospital Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28220
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, 08025
Complejo Hospitalario de Navarra
Pamplona, Navarre, 31008
Hospital Universitario Miguel Servet
Zaragoza
France6 sites
Institut Bergonie
Bordeaux, Aquitaine
Centre Georges Francois Leclerc
Dijon, Bourgogne-Franche-Comté
Centre Leon Berard
Lyon, Auvergne-Rhône-Alpes
Hopital Rene Huguenin - Institut Curie
Saint-Cloud, Île-de-France Region
Centre Hospitalier Regional et Universitaire - Hospital Bretonneau
Tours, Centre-Val de Loire
Institut Gustave Roussy
Villejuif, Île-de-France Region, 94800
Italy5 sites
Azienda Ospedaliero-Universitaria di Bologna-Policlinico S Orsola-Malpighi
Bologna
IRCCS Instituto Ortopedico Rizzoli
Bologna
Fondazione del Piemonte per l'Oncologia
Candiolo, Torino
Istituto Europeo di Oncologia Milano
Milan, 20141
Istituto Oncologico Veneto
Padova, 35128
Israel4 sites
Rambam Medical Center
Haifa
Sharet Institute of Oncology Hadassah Ein Karem Medical Center
Jerusalem
Chaim Sheba Medical Center
Ramat Gan
Tel Aviv Sourasky Medical Center
Tel Aviv
Canada3 sites
Cross Cancer Institute
Edmonton, Alberta
Juravinski Cancer Center
Hamilton, Ontario, LBV5C2
McGill University
Montreal, Quebec, H2W156
Russia3 sites
State Institution "Blokhin Cancer Research Centre RAMS"
Moscow, 115478
City Oncology Hospital #2
Moscow, 143423
Republican Clinical Oncologic Dispensary of Ministry of Health Republic Tatarstan
Tatarstan, 420029
Australia2 sites
Royal North Shore Hospital
Saint Leonards, New South Wales
Westmead Hospital
Westmead, New South Wales
Netherlands1 site
Leiden Universitair Medisch Centrum
Leiden, South Holland, 2333ZA
About this study
Official title: A Multicenter, Randomized, Open-Label Phase 3 Study to Investigate the Efficacy and Safety of Aldoxorubicin Compared to Investigator's Choice in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcomas Who Either Relapsed or Were Refractory to Prior Non-Adjuvant Chemotherapy
The purpose of this study is to determine the efficacy and safety of aldoxorubicin in subjects with metastatic, locally advanced, or unresectable soft tissue sarcomas.
- Being tested
- Aldoxorubicin, Investigator's Choice Treatment (Darcabazine, Pazopanib, Gemcitabine + Docetaxel, Doxorubicin, Ifosfamide)
- Keywords
- soft tissue sarcoma, unresectable, metastatic, locally advanced, sarcoma
- 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.
AldoxorubicinDrug
Also called INNO-206
Investigator's Choice Treatment (Darcabazine, Pazopanib, Gemcitabine + Docetaxel, Doxorubicin, Ifosfamide)Drug
Also called Darcabazine, Pazopanib, Gemcitabine + Docetaxel, Doxorubicin
| Study group | Role | What they receive |
|---|---|---|
| Aldoxorubicin | Experimental | Aldoxorubicin is administered at 350 mg/m2 (260 mg/m2 doxorubicin equivalent) intravenously on Day 1 every 21-day cycles until tumor progression or unacceptable toxicity occurs. Receives: Drug: Aldoxorubicin |
| Investigator's Choice of Treatment | Active comparator | These treatments include:
1. Dacarbazine administered at 1000 mg/m2 by intravenous infusion (IVI), over 90±15 minutes on Day 1 every 21 days until tumor progression or unacceptable toxicity occurs;
2. Pazopanib, 800 mg orally each day until tumor progression or unacceptable toxicity occurs;
3. Gemcitabine, 900 mg/m2 by IVI over 90 minutes on Days 1 and 8, plus docetaxel, 100 mg/m2 by IVI over 1 hour on Day 8 of a 28 day cycle until tumor progression or unacceptable toxicity occurs;
4. Doxorubicin, 75 mg/m2 by IVI over 5 to 30 minutes every 21 days for a maximum cumulative dose of 550 mg/m2 or unacceptable toxicity occurs; or
5. Ifosfamide 2.0 g/m2 administered over 2 to 4 hours on Days 1-4 of a 21 day cycle + mesna per standard site administration regimen until tumor progression or unacceptable toxicity occurs. Receives: Drug: Investigator's Choice Treatment (Darcabazine, Pazopanib, Gemcitabine + Docetaxel, Doxorubicin, Ifosfamide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
PFS is defined as the time from the date of randomization to first documentation of objective tumor progression, according to RECIST 1.1 Criteria, or to death due to any cause in the absence of previous documentation of objective tumor progression. For subjects without documentation of objective tumor progression, who started other anti-tumor treatment, or lost to follow up/withdrew consent prior to confirmed progression, PFS is censored at the date of the last tumor assessment.
PFS is defined as the interval from the date of randomization to the earliest date of documented evidence of recurrent or progressive disease, or the date of death due to any cause, whichever occurs first.
PD is defined as: 20% increase in the sum of the longest diameter of target lesions from the smallest sum of the longest diameter recorded since the treatment started; the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 new lesion is also considered PD.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionMay 2017
- Study completionMay 2017
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 433 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImmunityBio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02049905
- Sponsor's protocol ID
- ALDOXORUBICIN-P3-STS-01
- Status last verified
- Jun 2017
- First submitted
- 28 Jan 2014
- Last updated
- 13 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-Label Phase 3 Study to Investigate the Efficacy and Safety of Aldoxorubicin Compared to Investigator's Choice in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcomas Who Either Relapsed or Were Refractory to Prior Non-Adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT02049905
- Acronym / sponsor ID
- ALDOXORUBICIN-P3-STS-01
- Keywords
- soft tissue sarcoma, unresectable, metastatic, locally advanced, sarcoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 433 participants (actual)
- Lead sponsor
- ImmunityBio, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 30 Jan 2014 (estimated)
- Results
- Posted 13 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the efficacy and safety of aldoxorubicin in subjects with metastatic, locally advanced, or unresectable soft tissue sarcomas.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aldoxorubicin | Experimental | Drug: AldoxorubicinAldoxorubicin is administered at 350 mg/m2 (260 mg/m2 doxorubicin equivalent) intravenously on Day 1 every 21-day cycles until tumor progression or unacceptable toxicity occurs. |
| Investigator's Choice of Treatment | Active comparator | Drug: Investigator's Choice Treatment (Darcabazine, Pazopanib, Gemcitabine + Docetaxel, Doxorubicin, Ifosfamide)These treatments include: 1. Dacarbazine administered at 1000 mg/m2 by intravenous infusion (IVI), over 90±15 minutes on Day 1 every 21 days until tumor progression or unacceptable toxicity occurs; 2. Pazopanib, 800 mg orally each day until tumor progression or unacceptable toxicity occurs; 3. Gemcitabine, 900 mg/m2 by IVI over 90 minutes on Days 1 and 8, plus docetaxel, 100 mg/m2 by IVI over 1 hour on Day 8 of a 28 day cycle until tumor progression or unacceptable toxicity occurs; 4. Doxorubicin, 75 mg/m2 by IVI over 5 to 30 minutes every 21 days for a maximum cumulative dose of 550 mg/m2 or unacceptable toxicity occurs; or 5. Ifosfamide 2.0 g/m2 administered over 2 to 4 hours on Days 1-4 of a 21 day cycle + mesna per standard site administration regimen until tumor progression or unacceptable toxicity occurs. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Has provided written informed consent prior to any study related activities.
- Age ≥15 years (US only), and 18-80 (rest of world (ROW)), male or female.
- Histological confirmation of intermediate or high grade soft-tissue sarcoma. Tissue must be sent to a central pathology lab for review but will not preclude entry onto the study. Final assignment of tumor grade and histology will be based on the designation provided by the central pathology review.
- An adequate tumor specimen obtained by either excisional biopsy, incisional biopsy or core needle biopsy must be sent to the central pathology lab for evaluation. The material must measure at least 0.8 × 0.1 cm in size or contain at least 50 tumor cells.
- Locally advanced, unresectable, and/or metastatic soft-tissue sarcoma of intermediate or high grade with evidence of disease progression by either computed tomography (CT) or magnetic resonance imaging (MRI) scan, or clinical judgment on or after the last cancer therapy within 6 months prior to randomization.
Key exclusion criteria (20 listed)
- Prior exposure to >375 mg/m2 of doxorubicin or liposomal doxorubicin.
- Palliative surgery and/or radiation treatment within 30 days prior to date of randomization.
- Exposure to any investigational agent within 30 days of date of randomization.
- Exposure to any systemic chemotherapy within 30 days of date of randomization.
- An inadequate tumor specimen as defined by the central pathologist.
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 |
|---|---|---|
| AldoxorubicinAlso: INNO-206 | Drug | Aldoxorubicin |
| Investigator's Choice Treatment (Darcabazine, Pazopanib, Gemcitabine + Docetaxel, Doxorubicin, Ifosfamide)Also: Darcabazine, Pazopanib, Gemcitabine + Docetaxel, Doxorubicin | Drug | Investigator's Choice of Treatment |
Primary outcome
Progression-Free Survival (PFS)
Time frame: 24 months
PFS is defined as the time from the date of randomization to first documentation of objective tumor progression, according to RECIST 1.1 Criteria, or to death due to any cause in the absence of previous documentation of objective tumor progression. For subjects without documentation of objective tumor progression, who started other anti-tumor treatment, or lost to follow up/withdrew consent prior to confirmed progression, PFS is censored at the date of the last tumor assessment. PFS is defined as the interval from the date of randomization to the earliest date of documented evidence of recurrent or progressive disease, or the date of death due to any cause, whichever occurs first. PD is defined as: 20% increase in the sum of the longest diameter of target lesions from the smallest sum of the longest diameter recorded since the treatment started; the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 new lesion is also considered PD.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
74 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aldoxorubicin and Investigator's Choice Treatment (Darcabazine, Pazopanib, Gemcitabine + Docetaxel, Doxorubicin, Ifosfamide) in people with Metastatic, Locally Advanced or Unresectable Soft Tissue Sarcoma, run by ImmunityBio, Inc. at 74 sites in 13 countries.
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 14 inclusion and 20 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 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 74 sites in United States, Spain, France, Italy, Israel and 8 more countries. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 13 Jun 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?
Progression-Free Survival (PFS) (time frame: 24 months). 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 13 Jun 2024.