Colorectal Neoplasms, Esophageal Neoplasms, Hepatocellular Carcinoma, Neoplasms, Ovarian Neoplasms, Pancreatic Neoplasms
Conditions
Keywords
Esophageal Neoplasms, Esophagus Neoplasm, Esophagus Cancer, Esophageal Cancer, Esophageal Tumors, Esophagus Tumors, Neoplasms, Esophageal, Hepatocellular Carcinoma, Carcinoma, Hepatocellular, Hepatoma, Colorectal Neoplasms, Colorectal Cancer, Colorectal Carcinoma, Colorectal Tumor, Neoplasms, Colorectal, Ovarian Neoplasms, Ovary Neoplasms, Ovary Cancer, Ovary Carcinoma, Ovarian Cancer, Ovarian Carcinoma, Neoplasms, Ovarian, Pancreatic Neoplasms, Pancreatic Cancer, Pancreas Neoplasms, Pancreas Cancer, Neoplasms, Pancreatic, Neoplasms, Pancreas, and other solid tumors
Brief summary
To determine the rate of response and the duration of the response following therapy with Aroplatinin patients with advanced solid malignancies.
Detailed 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
Interventions
Sponsors
Aronex Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed