A Randomized Phase 3, Multicenter, Open-Label Study Comparing TH-302 in Combination with Doxorubicin vs. Doxorubicin Alone in Subjects with Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma
Complexity Level: 2
Eligibility: Male or female 15 years of age or older, has provided informed consent to participate, has pathologically confirmed diagnosis of soft tissue sarcoma for which doxorubicin is appropriate single agent therapy (see main protocol for details), disease is locally advanced unresectable or metastatic with no standard curative therapy available, measurable disease by RECIST 1.1 criteria, ECOG PS of 0 or 1, recovered from prior therapy, life expectancy of at least 3 months, acceptable blood test results for liver, renal and bone marrow function, acceptable cardiac function, must agree to use contraception.
Objectives: PRIMARY OBJECTIVES: To evaluate the efficacy and safety of TH-302 in combination with doxorubicin as determined by overall survival in subjects with locally advanced unresectable or metastatic soft tissue sarcoma previously untreated with chemotherapy (neoadjuvant and adjuvant chemotherapy permitted) compared with doxorubicin alone. SECONDARY OBJECTIVES: To evaluate the efficacy of TH-302 in combination with doxorubicin as determined by progression-free survival and response rate in subjects; to investigate the pharmacokinetics of TH-302, Br-IPM, doxorubicin and doxorubicinol in plasma. TERTIARY OBJECTIVES: to evaluate the efficacy of TH-302 in combination with doxorubicin as determined by overall survival at 6 and 12 months, progression free rate at 3 and 6 months, duration of response, stable disease or better rate, change in ECOG and performance status; to explore and compare quality of life and derive health state utilities.
NCT Registration ID (from clinicaltrials.gov): NCT01440088
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: July 20, 2012 Closing Date: December 26, 2013