A Safety and Effectiveness Study of Aroplatin in Patients With Advanced Solid Malignancies
This trial is active, not recruiting.
|Conditions||esophageal neoplasms, hepatocellular carcinoma, colorectal neoplasms, ovarian neoplasms, pancreatic neoplasms, neoplasms|
|Treatment||aroplatin (liposomal nddp, l-nddp)|
|Phase||phase 1/phase 2|
|Trial size||40 participants|
|Trial identifier||NCT00057395, C-726-04|
To determine the rate of response and the duration of the response following therapy with Aroplatinin patients with advanced solid malignancies.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Male or female participants at least 18 years old.
Inclusion Criteria: - Advanced solid malignancies; - Amenable to therapy with DACH platinum agents; - Measurable disease (RECIST criteria); - ECOG performance score of 0-2; - Adequate hematopoietic, liver and renal function; - Adequate cardiac function (maximum of class II, NYHA); - Women of childbearing potential must have a negative urine or serum pregnancy test; - Signed written informed consent; - Subjects must be willing to be followed during the course of treatment/observation and follow-up. Exclusion Criteria: - No other active malignancies; - No prior therapy with oxaliplatin; - No known brain metastases; - Active, uncontrolled infection or other serious medical illnesses; - Not using or have used any investigational therapy during four weeks before start of protocol treatment.
|Official title||A Phase I/II Study of Aroplatin™ in Patients With Advanced Solid Malignancies|
|Description||Primary Objective: - Determine response rate (RR; complete and partial response [CR, PR]) and duration after therapy with Aroplatin™ in patients with advanced solid malignancies. Secondary Objective: - Determine the safety and tolerability of Aroplatin|
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