Preliminary Efficacy and Safety of INNO-206 Compared to Doxorubicin in Advanced Soft Tissue Sarcoma

NCT01514188 | Completed Phase 2 Results DMC

• 1 other identifier: INNO-206-P2-STS-01
• Study Type: interventional
• Target: 126
• Locations: 7 countries
• Sites: 34

Brief 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 chemotherapy, and no evidence of tumor recurrence has occurred for at least 12 months.

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

Outcome Measures

Primary Outcomes (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.

  Approximately 24 months

Secondary Outcomes (4)

• Overall Survival

  Approximately 35 months

• Progression-free Survival at 4 and 6 Months

  Month 4 and 6

• Objective Overall Response Rate (ORR)

  Approximately 24 months

• Number of Participants With Treatment-related Toxicities (Adverse Events)

  30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days)

Study Arms (2)

Doxorubicin

ACTIVE COMPARATOR

Drug: Doxorubicin

INNO-206

EXPERIMENTAL

Drug: INNO-206

Interventions

INNO-206 DRUG

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

Also known as: DOXO-EMCH

INNO-206

Doxorubicin DRUG

Doxorubicin administered at 75 mg/m2 for up to 6 consecutive cycles.

Doxorubicin

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• ImmunityBio, Inc.: lead

Study Sites (34)

Sarcoma Oncology Center

Santa Monica, California, 90403, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Pennsylvania Hematology Oncology Associates

Philadelphia, Pennsylvania, 19106, United States

Location

CTRC Institute for Drug Development, University of Texas

San Antonio, Texas, 78229-3900, United States

Location

Royal North Shore

St Leonards, New South Wales, 2065, Australia

Location

Epworth HealthCare Clinical Trials and Research Centre

Richmond, Victoria, Australia

Location

Border Medical Oncology

Wodonga, Victoria, 3690, Australia

Location

Royal Hobart Hospital

Hobart, Australia

Location

Royal Perth Hospital

Perth, 6000, Australia

Location

Mount Medical Centre

Perth, Australia

Location

The Crown Princess Mary Cancer Centre Westmead

Sydney, 2145, Australia

Location

State Health Centre Oncology Department

Budapest, Hungary

Location

Hemato Oncology Clinic, Vedanta Institute of Medical Science

Thaltej, Ahmedaba, 380054, India

Location

Hemato Oncology Clinic, Vedanta Institute of Medical Science

Ahmedabad, Gujarat, 380009, India

Location

M.S. Ramaiah Medical College and Hospitals

Bangalore, Karnataka, 560054, India

Location

Curie Manavata Cancer Centre

Nashik, Maharashtra, 422101, India

Location

Delhi State Cancer Institute

Pune, Maharashtra, 411001, India

Location

Jehangir Clinical Development Centre Pvt Ltd

Pune, Maharashtra, 411001, India

Location

Delhi State Cancer Institute

Mandoli, National Capital Territory of Delhi, 110095, India

Location

Noble Hospital Clinical Research Department 1st Floor

Hadapsar, Pune Maharashtra, 411013, India

Location

Christian Medical College

Vellore, Tami Nadu, 532004, India

Location

Tata Memorial Hospital, Department of Medical Oncology

Mumbai, 400012, India

Location

Oncological Institute "Prof. Dr. I. Chiricuta", Cluj-Napoca

Cluj-Napoca, County Cluj, 400015, Romania

Location

Clinical County Hospital Mures, Medical Oncology Department

Târgu Mureş, County Mures, 540141, Romania

Location

Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia-Mare, Sectia Oncologie

Baia Mare, Judet Maramures, 430031, Romania

Location

Medisprof SRL

Cluj-Napoca, Romania

Location

State Healthcare Institution "Republican Clinical Oncological Center of the Ministry of Health of Republic of Tatarstan"

Kazan', Tatarstan Republic, 420029, Russia

Location

Blokhin Cancer Research Center

Moscow, 115478, Russia

Location

Municipal institution "Chernivtsi Regional Clinical Oncologic Dispensary",

Chernivtsi, 58013, Ukraine

Location

Municipal Institution "Dnipropetrovsk City Multi-Field Clinical Hospital #4" of Dnipropetrovsk Regional Councel

Dnipropetrovsk, 49102, Ukraine

Location

State Institution "Institute of Medical Radiology named after S.P.Grygoryev of National Academy of Medical Sciences of Ukraine",

Kharkiv, 61024, Ukraine

Location

Lviv State Oncological Regional Treatment - Diagnostics Center, Chemotherapy Department

Lviv, 79031, Ukraine

Location

Vinnytsya Regional Clinical Oncologic Dispensary, Surgical Department

Vinnytsia, 21029, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 26378637 DERIVED

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Sarcoma; Neoplasm Metastasis

Interventions

DOXO-EMCH; Doxorubicin

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Results Point of Contact

• Title: Sandeep Bobby Reddy, Chief Medical Officer
• Organization: ImmunityBio

Bobby.Reddy@Immunitybio.com

855-797-9277

Study Officials

• Sant Chawla, M.D.

  Sarcoma Oncology Center

  PRINCIPAL INVESTIGATOR

• Daniel Levitt, M.D., Ph.D.

  CytRx

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2012
• First Posted: January 23, 2012
• Study Start: January 11, 2012
• Primary Completion: April 9, 2014
• Study Completion: December 15, 2014
• Last Updated: May 29, 2024
• Results First Posted: May 29, 2024

Record last verified: 2013-09

Locations

AU (7); UA (5); US (5); RU (2); IN (10); HU (1); RO (4)