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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in India

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

Other trials in Australia

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

Other trials in United States

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

Other trials in Ukraine

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

Other trials in Romania

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

Other trials in Russia

Hungary1 site

  • State Health Centre Oncology Department

    Budapest

Other trials in Hungary

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).

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 groups in NCT01514188
Study groupRoleWhat they receive
DoxorubicinActive comparatorNot described
Receives: Drug: Doxorubicin
INNO-206ExperimentalNot described
Receives: Drug: INNO-206

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

  1. 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

  2. Progression-free Survival at 4 and 6 Months

    Measured: Month 4 and 6

  3. 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

  4. 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.

  1. First posted23 Jan 2012 (estimated)
  2. Study start11 Jan 2012
  3. Primary completion9 Apr 2014
  4. Study completion15 Dec 2014

Resources

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)
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
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

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.

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