A Trial of TH-302 in Combination With Doxorubicin Versus Doxorubicin Alone to Treat Patients With Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma

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ClinicalTrials.gov Identifier: NCT01440088

Recruitment Status : Completed

First Posted : September 26, 2011

Last Update Posted : June 2, 2016

View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborator:

Sarcoma Alliance for Research through Collaboration (SARC)

Information provided by (Responsible Party):

Threshold Pharmaceuticals

Results Submitted - Not Posted on ClinicalTrials.gov

Results information has been submitted to ClinicalTrials.gov by the sponsor or investigator, but is not yet publicly available (or "posted") on ClinicalTrials.gov. The submitted information may not be available if it is pending Quality Control (QC) Review by the National Library of Medicine (NLM) or if issues identified during QC review are being addressed or corrected by the sponsor or investigator. NLM's limited QC review assesses for apparent errors, deficiencies, or inconsistencies. NLM staff do not verify the scientific validity or relevance of the submitted information.

Recruitment Status :	Completed
Actual Primary Completion Date :	December 2015
Actual Study Completion Date :	May 2016

Submission Cycle	Results Submitted to ClinicalTrials.gov	Results Returned after Quality Control Review
1	July 18, 2017	August 16, 2017
2	August 23, 2017	September 21, 2017
3	October 26, 2017	November 30, 2017
4	March 18, 2021	April 15, 2021

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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, Schoffski 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.

Chawla SP, Cranmer LD, Van Tine BA, Reed DR, Okuno SH, Butrynski JE, Adkins DR, Hendifar AE, Kroll S, Ganjoo KN. Phase II study of the safety and antitumor activity of the hypoxia-activated prodrug TH-302 in combination with doxorubicin in patients with advanced soft tissue sarcoma. J Clin Oncol. 2014 Oct 10;32(29):3299-306. doi: 10.1200/JCO.2013.54.3660. Epub 2014 Sep 2.

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