Metastatic Soft Tissue SarcomaPhase 2NCT01514188
Preliminary Efficacy and Safety of INNO-206 Compared to Doxorubicin in Advanced Soft Tissue Sarcoma
A Phase 2 study testing INNO-206 and Doxorubicin in people with Metastatic Soft Tissue Sarcoma and Locally Advanced Soft Tissue Sarcoma, run by ImmunityBio, Inc. at 34 sites in 7 countries.
Trial summary
This is a phase 2b, randomized, open-label, prospective, multicenter study comparing treatment with INNO 206 to doxorubicin in subjects with metastatic, locally advanced, or unresectable soft tissue sarcomas who have not been previously treated with any chemotherapy except potentially as adjuvant or neoadjuvant… Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Metastatic Soft Tissue Sarcoma, Locally Advanced Soft Tissue Sarcoma, Unresectable Soft Tissue Sarcoma
- What is being tested?
- INNO-206 and Doxorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 34 sitesin 7 countries
- Study dates
- 11 Jan 2012to 15 Dec 2014
- Phase
- Phase 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 (US only), and 18-80 (rest of world (ROW)), 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 of intermediate or high grade.
- Capable of providing informed consent and complying with trial procedures.
- ECOG performance status 0-2.
- Life expectancy > 12 weeks.
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- Measurable tumor lesions according to RECIST 1.1 criteria.
- 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.)
- 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 4 weeks prior to Randomization.
- Exposure to any investigational agent within 30 days of Randomization.
- Current Stage 1 or 2 soft tissue sarcomas.
- Current evidence/diagnosis of alveolar soft part sarcoma, chondrosarcoma, rhabdomyosarcoma, osteosarcoma, gastrointestinal stromal tumor (GIST), dermatofibrosarcoma, Ewing's sarcoma, Kaposi's sarcoma, mixed mesodermal tumor, clear cell sarcomas and unresectable low grade liposarcomas.
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- Central nervous system metastasis
- 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, or coagulation tests (prothrombin time [PT], partial thromboplastin time [PTT], International Normalized Ratio [INR]) > 1.5 × ULN, albumin < 2.0 g/dL.
- 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 as scintigraphically (e.g. MUGA, myocardial scintigram) or ultrasound determined absolute left ventricular ejection fraction (LVEF) < 45% of predicted.
- History of HIV infection.
- Active, clinically significant serious infection requiring treatment with antibiotics, anti-virals or anti-fungals.
- Major surgery within 3 weeks prior to Randomization.
- 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
34 sites in 7 countries.
34 sites in 7 countries
India10 sites
Hemato Oncology Clinic, Vedanta Institute of Medical Science
Ahmedabad, Gujarat, 380009
M.S. Ramaiah Medical College and Hospitals
Bangalore, Karnataka, 560054
Noble Hospital Clinical Research Department 1st Floor
Hadapsar, Pune Maharashtra, 411013
Delhi State Cancer Institute
Mandoli, National Capital Territory of Delhi, 110095
Tata Memorial Hospital, Department of Medical Oncology
Mumbai, 400012
Curie Manavata Cancer Centre
Nashik, Maharashtra, 422101
Delhi State Cancer Institute
Pune, Maharashtra, 411001
Jehangir Clinical Development Centre Pvt Ltd
Pune, Maharashtra, 411001
Hemato Oncology Clinic, Vedanta Institute of Medical Science
Thaltej, Ahmedaba, 380054
Christian Medical College
Vellore, Tami Nadu, 532004
Australia7 sites
Royal Hobart Hospital
Hobart
Royal Perth Hospital
Perth, 6000
Mount Medical Centre
Perth
Epworth HealthCare Clinical Trials and Research Centre
Richmond, Victoria
Royal North Shore
St Leonards, New South Wales, 2065
The Crown Princess Mary Cancer Centre Westmead
Sydney, 2145
Border Medical Oncology
Wodonga, Victoria, 3690
United States5 sites
University of Iowa
Iowa City, Iowa, 52242
Pennsylvania Hematology Oncology Associates
Philadelphia, Pennsylvania, 19106
CTRC Institute for Drug Development, University of Texas
San Antonio, Texas, 78229-3900
Sarcoma Oncology Center
Santa Monica, California, 90403
Stanford University
Stanford, California, 94305
Ukraine5 sites
Municipal institution "Chernivtsi Regional Clinical Oncologic Dispensary",
Chernivtsi, 58013
Municipal Institution "Dnipropetrovsk City Multi-Field Clinical Hospital #4" of Dnipropetrovsk Regional Councel
Dnipropetrovsk, 49102
State Institution "Institute of Medical Radiology named after S.P.Grygoryev of National Academy of Medical Sciences of Ukraine",
Kharkiv, 61024
Lviv State Oncological Regional Treatment - Diagnostics Center, Chemotherapy Department
Lviv, 79031
Vinnytsya Regional Clinical Oncologic Dispensary, Surgical Department
Vinnytsia, 21029
Romania4 sites
Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia-Mare, Sectia Oncologie
Baia Mare, Judet Maramures, 430031
Oncological Institute "Prof. Dr. I. Chiricuta", Cluj-Napoca
Cluj-Napoca, County Cluj, 400015
Medisprof SRL
Cluj-Napoca
Clinical County Hospital Mures, Medical Oncology Department
Târgu Mureş, County Mures, 540141
Russia2 sites
State Healthcare Institution "Republican Clinical Oncological Center of the Ministry of Health of Republic of Tatarstan"
Kazan', Tatarstan Republic, 420029
Blokhin Cancer Research Center
Moscow, 115478
About this study
Official title: A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared to Doxorubicin in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma
This is a phase 2b, randomized, open-label, prospective, multicenter study comparing treatment with INNO 206 to doxorubicin in subjects with metastatic, locally advanced, or unresectable soft tissue sarcomas who have not been previously treated with any chemotherapy except potentially as adjuvant or neoadjuvant chemotherapy, and no evidence of tumor recurrence has occurred for at least 12 months.
Read the detailed description
One hundred five subjects will be enrolled and randomized 2:1 to receive either INNO-206 or doxorubicin. INNO-206 at a dosage of 350 mg/m2 (doxorubicin equivalents of 260 mg/m2) will be administered as a 30 minute IVI on Day 1 of each cycle to approximately 70 subjects. Doxorubicin (75 mg/m2) will be administered to approximately 35 subjects on Day 1 of each cycle. An individual cycle of therapy will be defined as a 3-week (21-day) period. Cycles will be repeated every 3 weeks. Multiple cycles may be administered until the subject is withdrawn from therapy or until a maximum of 6 cycles are administered. Overall response rates as well as individual categories of response (CR, PR, SD, and PD) will be determined using RECIST 1.1.[28] Time-to-event endpoints, including PFS and OS will be assessed using the Kaplan Meier method.[30] Evaluation of 4- and 6-month progression-free survival will also be performed. Toxicity (adverse events) will be recorded using the NCI CTCAE, version 4.0 (published 28 May 2009).
- Conditions
- Metastatic Soft Tissue Sarcoma, Locally Advanced Soft Tissue Sarcoma, Unresectable Soft Tissue Sarcoma
- Being tested
- INNO-206, Doxorubicin
- Keywords
- sarcoma, soft-tissue sarcoma, Metastatic,locally advanced, or unresectable soft tissue sarcoma
- Medical subject headings
- Sarcoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INNO-206Drug
Also called DOXO-EMCH
INNO-206 administered at 350 mg/m2 (260 mg/m2 doxorubicin equivalent) intravenously (IV) on Day 1 every 21 days for up to 6 consecutive cycles
DoxorubicinDrug
Doxorubicin administered at 75 mg/m2 for up to 6 consecutive cycles.
| Study group | Role | What they receive |
|---|---|---|
| Doxorubicin | Active comparator | Not described Receives: Drug: Doxorubicin |
| INNO-206 | Experimental | Not described Receives: Drug: INNO-206 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival
Progression-free survival is defined as the interval from the date of registration (ie, assignment of subject number) to the earliest date of documented evidence of recurrent or progressive disease, or the date of death due to any cause, whichever occurs first.
Progressive Disease 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 progression.
Measured: Approximately 24 months
Secondary outcomes (4)
Overall Survival
Overall survival was measured from the date of registration (ie, assignment of subject number) to the date of death due to any cause, or the date of last contact.
Measured: Approximately 35 months
Progression-free Survival at 4 and 6 Months
Measured: Month 4 and 6
Objective Overall Response Rate (ORR)
Objective Overall Response will be evaluated using the Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1). Changes (i.e., improvements) in tumor measurements from baseline values will be assigned a status of CR or PR. Objective response measurements will comprise the sum of CR plus PR.
Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm).
Partial Response (PR): 30% decrease in the sum of the longest diameter of target lesions, from the baseline sum longest diameter.
Measured: Approximately 24 months
Number of Participants With Treatment-related Toxicities (Adverse Events)
Treatment will continue every 21 days until tumor progression is observed, 6 cycles of treatment are completed or unacceptable toxicity occurs.
Measured: 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2012 (estimated)
- Study start11 Jan 2012
- Primary completion9 Apr 2014
- Study completion15 Dec 2014
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImmunityBio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sant Chawla, M.D., Principal investigator, Sarcoma Oncology CenterDaniel Levitt, M.D., Ph.D., Study director, CytRx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01514188
- Sponsor's protocol ID
- INNO-206-P2-STS-01
- Status last verified
- Sep 2013
- First submitted
- 12 Jan 2012
- Last updated
- 29 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Chawla SP, Papai Z, Mukhametshina G, Sankhala K, Vasylyev L, Fedenko A, Khamly K, Ganjoo K, Nagarkar R, Wieland S, Levitt DJ. First-Line Aldoxorubicin vs Doxorubicin in Metastatic or Locally Advanced Unresectable Soft-Tissue Sarcoma: A Phase 2b Randomized Clinical Trial. JAMA Oncol. 2015 Dec;1(9):1272-80. doi: 10.1001/jamaoncol.2015.3101.
PubMed 26378637
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
- A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared to Doxorubicin in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT01514188
- Acronym / sponsor ID
- INNO-206-P2-STS-01
- Conditions
- Metastatic Soft Tissue Sarcoma, Locally Advanced Soft Tissue Sarcoma, Unresectable Soft Tissue Sarcoma
- Keywords
- sarcoma, soft-tissue sarcoma, Metastatic,locally advanced, or unresectable soft tissue sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- ImmunityBio, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Jan 2012 (actual)
- Primary completion
- 9 Apr 2014 (actual)
- Study completion
- 15 Dec 2014 (actual)
- First posted
- 23 Jan 2012 (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 2b, randomized, open-label, prospective, multicenter study comparing treatment with INNO 206 to doxorubicin in subjects with metastatic, locally advanced, or unresectable soft tissue sarcomas who have not been previously treated with any chemotherapy except potentially as adjuvant or neoadjuvant chemotherapy, and no evidence of tumor recurrence has occurred for at least 12 months.
Detailed description
One hundred five subjects will be enrolled and randomized 2:1 to receive either INNO-206 or doxorubicin. INNO-206 at a dosage of 350 mg/m2 (doxorubicin equivalents of 260 mg/m2) will be administered as a 30 minute IVI on Day 1 of each cycle to approximately 70 subjects. Doxorubicin (75 mg/m2) will be administered to approximately 35 subjects on Day 1 of each cycle. An individual cycle of therapy will be defined as a 3-week (21-day) period. Cycles will be repeated every 3 weeks. Multiple cycles may be administered until the subject is withdrawn from therapy or until a maximum of 6 cycles are administered. Overall response rates as well as individual categories of response (CR, PR, SD, and PD) will be determined using RECIST 1.1.[28] Time-to-event endpoints, including PFS and OS will be assessed using the Kaplan Meier method.[30] Evaluation of 4- and 6-month progression-free survival will also be performed. Toxicity (adverse events) will be recorded using the NCI CTCAE, version 4.0 (published 28 May 2009).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doxorubicin | Active comparator | Drug: Doxorubicin |
| INNO-206 | Experimental | Drug: INNO-206 |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Age between 15-80 years (US only), and 18-80 (rest of world (ROW)), 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 of intermediate or high grade.
- Capable of providing informed consent and complying with trial procedures.
- ECOG performance status 0-2.
Key exclusion criteria (19 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 4 weeks prior to Randomization.
- Exposure to any investigational agent within 30 days of Randomization.
- 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 |
|---|---|---|
| INNO-206Also: DOXO-EMCHINNO-206 administered at 350 mg/m2 (260 mg/m2 doxorubicin equivalent) intravenously (IV) on Day 1 every 21 days for up to 6 consecutive cycles | Drug | INNO-206 |
| DoxorubicinDoxorubicin administered at 75 mg/m2 for up to 6 consecutive cycles. | Drug | Doxorubicin |
Primary outcome
Progression-free Survival
Time frame: Approximately 24 months
Progression-free survival is defined as the interval from the date of registration (ie, assignment of subject number) to the earliest date of documented evidence of recurrent or progressive disease, or the date of death due to any cause, whichever occurs first. Progressive Disease 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 progression.
4 secondary outcomes
Overall Survival
Time frame: Approximately 35 months
Progression-free Survival at 4 and 6 Months
Time frame: Month 4 and 6
Objective Overall Response Rate (ORR)
Time frame: Approximately 24 months
Number of Participants With Treatment-related Toxicities (Adverse Events)
Time frame: 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days)
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.
- Derived from this study: PubMed 26378637Chawla SP, Papai Z, Mukhametshina G, Sankhala K, Vasylyev L, Fedenko A, Khamly K, Ganjoo K, Nagarkar R, Wieland S, Levitt DJ. First-Line Aldoxorubicin vs Doxorubicin in Metastatic or Locally Advanced Unresectable Soft-Tissue Sarcoma: A Phase 2b Randomized Clinical Trial. JAMA Oncol. 2015 Dec;1(9):1272-80. doi: 10.1001/jamaoncol.2015.3101.
- 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.
Sant Chawla, M.D. principal investigator
Sarcoma Oncology Center
Daniel Levitt, M.D., Ph.D. study director
CytRx
34 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing INNO-206 and Doxorubicin in people with Metastatic Soft Tissue Sarcoma and Locally Advanced Soft Tissue Sarcoma, run by ImmunityBio, Inc. at 34 sites in 7 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 10 inclusion and 19 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 34 sites in India, Australia, United States, Ukraine, Romania and 2 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 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?
Progression-free Survival (time frame: Approximately 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01514188, which also lists 1 linked publication.
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; AzTrials last refreshed its copy on 8 Nov 2026.