Spots Global Cancer Trial Database for Preliminary Efficacy and Safety of INNO-206 Compared to Doxorubicin in Advanced Soft Tissue Sarcoma
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Trial Identification
Brief Title: Preliminary Efficacy and Safety of INNO-206 Compared to Doxorubicin in Advanced Soft Tissue Sarcoma
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
Study ID: NCT01514188
Study Description
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.
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 Multiple cycles may be administered until the subject is withdrawn from therapy or until a maximum of 6 cycles are administered.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).
Eligibility
Minimum Age: 15 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Sarcoma Oncology Center, Santa Monica, California, United States
Stanford University, Stanford, California, United States
University of Iowa, Iowa City, Iowa, United States
Pennsylvania Hematology Oncology Associates, Philadelphia, Pennsylvania, United States
CTRC Institute for Drug Development, University of Texas, San Antonio, Texas, United States
Royal North Shore, St. Leonards, New South Wales, Australia
Epworth HealthCare Clinical Trials and Research Centre, Richmond, Victoria, Australia
Border Medical Oncology, Wodonga, Victoria, Australia
Royal Hobart Hospital, Hobart, , Australia
Royal Perth Hospital, Perth, , Australia
Mount Medical Centre, Perth, , Australia
The Crown Princess Mary Cancer Centre Westmead, Sydney, , Australia
State Health Centre Oncology Department, Budapest, , Hungary
Hemato Oncology Clinic, Vedanta Institute of Medical Science, Thaltej, Ahmedaba, India
Delhi State Cancer Institute, Mandoli, Delhi, India
Hemato Oncology Clinic, Vedanta Institute of Medical Science, Ahmedabad, Gujarat, India
M.S. Ramaiah Medical College and Hospitals, Bangalore, Karnataka, India
Curie Manavata Cancer Centre, Nashik, Maharashtra, India
Delhi State Cancer Institute, Pune, Maharashtra, India
Jehangir Clinical Development Centre Pvt Ltd, Pune, Maharashtra, India
Noble Hospital Clinical Research Department 1st Floor, Hadapsar, Pune Maharashtra, India
Christian Medical College, Vellore, Tami Nadu, India
Tata Memorial Hospital, Department of Medical Oncology, Mumbai, , India
Oncological Institute "Prof. Dr. I. Chiricuta", Cluj-Napoca, Cluj-Napoca, County Cluj, Romania
Clinical County Hospital Mures, Medical Oncology Department, Targu-Mures, County Mures, Romania
Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia-Mare, Sectia Oncologie, Baia-Mare, Judet Maramures, Romania
Medisprof SRL, Cluj-Napoca, , Romania
State Healthcare Institution "Republican Clinical Oncological Center of the Ministry of Health of Republic of Tatarstan", Kazan, Republic Of Tatarstan, Russian Federation
Blokhin Cancer Research Center, Moscow, , Russian Federation
Municipal institution "Chernivtsi Regional Clinical Oncologic Dispensary",, Chernivtsi, , Ukraine
Municipal Institution "Dnipropetrovsk City Multi-Field Clinical Hospital #4" of Dnipropetrovsk Regional Councel, Dnipropetrovsk, , Ukraine
State Institution "Institute of Medical Radiology named after S.P.Grygoryev of National Academy of Medical Sciences of Ukraine",, Kharkiv, , Ukraine
Lviv State Oncological Regional Treatment - Diagnostics Center, Chemotherapy Department, Lviv, , Ukraine
Vinnytsya Regional Clinical Oncologic Dispensary, Surgical Department, Vinnytsya, , Ukraine
Contact Details
Name: Sant Chawla, M.D.
Affiliation: Sarcoma Oncology Center
Role: PRINCIPAL_INVESTIGATOR
Name: Daniel Levitt, M.D., Ph.D.
Affiliation: CytRx
Role: STUDY_DIRECTOR
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