CytRx, a pharmaceutical company specializing in oncology, recently announced the initial results of a phase 3 trial, which showed that aldoxorubicin may be more efficacious for the treatment of soft tissue sarcoma (STS), with a better safety profile, than doxorubicin.1
Doxorubicin is an effective but highly toxic chemotherapy for the treatment of STS; researchers developed aldoxorubicin to deliver more concentrated levels of doxorubicin against tumor cells, while protecting healthy cells from chemotherapy-associated damage.
For this randomized trial, researchers enrolled 433 patients from 79 sites in the United States and Canada; each patient with metastatic, locally advanced, or unresectable STS, and for whom systemic therapy was not successful, was assigned to receive either aldoxorubicin or investigator’s choice of chemotherapy.
The initial evaluation did not show a significant difference in progression-free survival between the cohorts, though the objective response rate and disease control rate for the aldoxorubicin cohort were nearly double those in the investigator’s choice cohort. These rates were improved even for patients previously treated with doxorubicin.
Aldoxorubicin was not associated with toxicities of the heart, kidneys, or liver.
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Patients are being followed for the study’s secondary endpoint, overall survival. Further results will be announced in the fourth quarter of 2016.
- CytRx announces initial results of phase 3 trial of aldoxorubicin in patients with second-line soft tissue sarcoma; subsequent analysis to be announced fourth quarter 2016. PR Newswire. http://www.prnewswire.com/news-releases/cytrx-announces-initial-results-of-phase-3-trial-of-aldoxorubicin-in-patients-with-second-line-soft-tissue-sarcoma-subsequent-analysis-to-be-announced-fourth-quarter-2016-300296717.html. Updated July 11, 2016. Accessed July 20, 2016.