CytRx Corporation has started enrolment in an open-label Phase Ib clinical trial aimed to investigate the preliminary safety and activity of aldoxorubicin, a modified version of doxorubicin, plus gemcitabine in subjects with metastatic solid tumours.
The clinical trial will take place in centres including the Virginia G. Piper Cancer Centre in Scottsdale, Arizona, the Samuel Oschin Cancer Centre at Cedars Sinai Medical Centre, Los Angeles, California and the Sarcoma Oncology Centre in Santa Monica, California, US.
More than 30 male and female patients aged between 15 and 80 years with advanced, unresectable, metastatic solid tumours are expected to participate in this trial.
The participants being enrolled in the study are those with tumours that have either relapsed or were refractory to treatment with at least one prior chemotherapy or immunotherapy regimen, and for which no standard approved therapy exists.
CytRx CEO Steven Kriegsman said: "Initiation of clinical development of aldoxorubicin in combination with gemcitabine for the treatment of metastatic solid tumours represents a potentially significant expansion of our aldoxorubicin franchise in cancer treatment.
"The start of this combination chemotherapy with aldoxorubicin will allow our testing to move into a variety of new tumours such as pancreatic and ovarian cancers as well as haematological malignancies."
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During the trial, aldoxorubicin will be administered at escalating doses by intravenous infusion (IVI) on day one, every 21 days plus 900mg/m2 gemcitabine on days one and eight until disease progression, unacceptable toxicity or the patient withdraws consent.
The trial’s primary objective is to decide the preliminary safety of the administration of aldoxorubicin in combination with gemcitabine in subjects with metastatic solid tumours as measured by the frequency and severity of adverse events (AEs), abnormal findings on physical examination, laboratory tests, vital signs, echocardiograms (ECHO) or multiple-gated acquisition (MUGA) scans, electrocardiogram (ECG) results, and weight.
The second objective is to evaluate the activity of aldoxorubicin in combination with gemcitabine in this study which will be assessed by overall response rate (ORR), progression-free survival (PFS), and PFS at four and six months.
The enrolment for the clinical trial is expected to be finished by the third quarter of 2015.