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

TYPE OF SARCOMA: Locally advanced or metastatic soft tissue sarcoma
DRUG: TH-302 combined with doxorubicin vs. doxorubicin alone
ACCRUAL STATUS: Completed

OVERALL STUDY PRINCIPAL INVESTIGATOR:
William Tap, MD
Memorial Sloan Kettering Cancer Center

CLINICALTRIALS.GOV IDENTIFIER: NCT01440088

FOR STUDY DETAILS AND ELIGIBILITY CRITERIA: CLINICALTRIALS.GOV

PUBLICATIONS:
Younger E, Ballman K, Lu Y, Pápai Z, Van Tine BA, Attia S, Schöffski P, Reinke D, Tap WD, Jones RL. Subgroup analysis of older patients treated within the randomized phase 3 doxorubicin versus doxorubicin plus evofosfamide (SARC021) trial. J Geriatr Oncol. 2020 Apr;11(3):463-469. doi: 10.1016/j.jgo.2019.05.008. Epub 2019 May 22. PMID: 31126845.

Tap WD, Papai Z, Van Tine BA, Attia S, Ganjoo KN, Jones RL, Schuetze S, Reed D, Chawla SP, Riedel RF, Krarup-Hansen A, Toulmonde M, Ray-Coquard I, Hohenberger P, Grignani G, Cranmer LD, Okuno S, Agulnik M, Read W, Ryan CW, Alcindor T, Del Muro XFG, Budd GT, Tawbi H, Pearce T, Kroll S, Reinke DK, Schöffski P. Doxorubicin plus evofosfamide versus doxorubicin alone in locally advanced, unresectable or metastatic soft-tissue sarcoma (TH CR-406/SARC021): an international, multicentre, open-label, randomised phase 3 trial. Lancet Oncol. 2017 Aug;18(8):1089-1103. doi: 10.1016/S1470-2045(17)30381-9. Epub 2017 Jun 23. Erratum in: Lancet Oncol. 2018 Feb;19(2):e78. PMID: 28651927; PMCID: PMC7771354.

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