Aldoxorubicin Compared to Investigator's Choice in Soft Tissue Sarcoma
Research type
Research Study
Full title
A Multicenter, Randomized, Open-Label Phase 3 Study to Investigate the Efficacy and Safety of Aldoxorubicin Compared to Investigator’s Choice in Subjects with Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcomas Who Either Relapsed or Were Refractory to Prior Non-Adjuvant Chemotherapy
IRAS ID
173629
Contact name
Robin, Lewis Jones
Contact email
Sponsor organisation
CytRx Corporation
Eudract number
2013-004103-40
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
113,695, IND number
Duration of Study in the UK
2 years, 3 months, 1 days
Research summary
Soft tissue sarcoma is a rare, long-term debilitating and life-threatening disease, particularly when the cancer has spread to other parts of the body. Currently available treatments can be quite toxic and have not significantly impacted the time before patient’s tumours progress (get worse) or their overall survival. Aldoxorubicin is a modified form of a related, approved medication called doxorubicin. It was developed to circumvent the limitations of doxorubicin and other currently available treatments and it is hoped that it will work more effectively at fighting cancer.
In this study, aldoxorubicin is being compared to study doctor's choice of treatment. Males and females, aged between 18-80, with soft tissue sarcoma that has either spread, grown outside the organ it started in, or is unable to be removed may be eligible to take part in this study provided that their disease has either returned or has not responded to previous treatments. It is hoped that treating patients with aldoxorubicin will have fewer side effects and work more effectively at treating soft tissue sarcomas.
This study is being carried out at approximately 80 research sites across the world, including sites in the US, Canada, Australia, Latin America, and other European countries. In the UK, the study will be carried out in oncology departments in NHS hospitals. It is expected that approximately 400 participants will receive treatment until either their tumour has progressed or they experience unacceptable side effects. Participants will be randomised in a 1:1 ratio to receive either aldoxorubicin or the study doctor’s treatment choice. During the study they will undergo various tests and procedures, including blood tests and scans, to assess their safety and how their soft tissue sarcoma is responding to the treatment.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
15/EE/0126
Date of REC Opinion
30 Apr 2015
REC opinion
Further Information Favourable Opinion