US-based biopharmaceutical firm CytRx has started patient enrolment in an open-label Phase Ib clinical trial of aldoxorubicin plus ifosfamide/mesna as a first-line treatment in subjects with various sarcomas.
Aldoxorubicin is the modified version of CytRx’s widely-used chemotherapeutic agent, doxorubicin.
The trial is designed to investigate the preliminary safety and activity of aldoxorubicin plus ifosfamide/mesna and will be conducted under the supervision of Sarcoma Oncology Center director Dr Sant Chawla.
Dr Chawla is also the principal investigator of the company’s global Phase III pivotal trial for patients with soft tissue sarcoma (STS) which is being conducted under a Special Protocol Assessment with the US Food and Drug Administration (FDA).
Around 30 male and female patients aged between 15 and 80 with locally advanced, unresectable, and/or metastatic STS, chondrosarcoma or certain osteosarcomas will be enrolled in the trial, which is expected to be completed by the third quarter of 2015.
CytRx CEO Steven Kriegsman said: "The timely initiation of this trial marks yet another important clinical milestone for CytRx, highlights the diligent execution of our clinical strategy by CytRx’s research and development team, and if successful, will further expand the potential applications for the aldoxorubicin franchise.
"We are pleased that Dr Sant Chawla has agreed to serve as principal investigator for this study. His expertise and experience in treating cancer patients with aldoxorubicin will increase the likelihood for the success of this important treatment approach."
During the trial, aldoxorubicin will be administered at escalating doses by intravenous infusion (IVI) on day one every 28 days, and 1gm/m2/day of ifosfamide and an equivalent dose of mesna will be administered via continuous infusion with a portable pump for about up to 14 days every 28 days starting on day one of each cycle, until disease progression, unacceptable toxicity or the patient withdraws consent.
Primary objective of the trial is to determine the preliminary safety of administration of aldoxorubicin in combination with ifosfamide in patients with metastatic, locally advanced, or unresectable STS.
The trial’s secondary objective is to assess the activity of aldoxorubicin in combination with ifosfamide/mesna in these patients, evaluated by overall response rate (ORR), progression-free survival (PFS) and PFS at four and six months.