SR6

SR6 Details
Status: Closed
Activation Date: 2012JUL20
Closing Date: 2013DEC26
Phase: III

Description: 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

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.

Objective: 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.

Participation: Limited to invited centres

Lay Description: The purpose of this study is to compare the effects on patients and their soft tissue sarcoma of a new drug TH-302 compared to doxorubicin which is a commonly-used drug to treat this disease. This study will gather information on the safety and effect on the patient's cancer of TH-302 in combination with doxorubicin. The study will also look at how the drug is processed in the body.

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Hide Tissue Samples

Disease Site	Trial Code	Patients Accrued	Patients - Blocks	Patients - Slides	Patients - Blocks and/or Slides
SARCOMA	SR6	26	9	20	20

Hide TMA Samples

(Core size is 0.6 mm)

Disease Site	Trial Code	Patients Accrued	TMA Blocks	Patients on TMA Blocks
SARCOMA	SR6	26	1	9

Hide Fluid Samples

Disease Site	Trial Code	Patients Accrued	Patients - Whole Blood	Patients - Cellular Component of Blood	Patients - DNA extracted from Blood	Patients - RNA extracted from Blood	Patients - Plasma	Patients - Serum	Patients - Urine	Patients - Buccal
SARCOMA	SR6	26	0	0	0	0	0	0	0	0