A Phase I/II Study of Aroplatin™ in Patients With Advanced Solid Malignancies
Phase 1/Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Esophageal Neoplasms, Hepatocellular Carcinoma, Colorectal Neoplasms, Ovarian Neoplasms, Pancreatic Neoplasms, Neoplasms
Both
Esophageal Neoplasms, Hepatocellular Carcinoma, Colorectal Neoplasms, Ovarian Neoplasms, Pancreatic Neoplasms, Neoplasms
Trial Information
A Phase I/II Study of Aroplatin™ in Patients With Advanced Solid Malignancies
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
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Authority:
United States: Food and Drug Administration
Study ID:
C-726-04
NCT ID:
NCT00057395
Start Date:
Completion Date:
Related Keywords:
- Esophageal Neoplasms
- Hepatocellular Carcinoma
- Colorectal Neoplasms
- Ovarian Neoplasms
- Pancreatic Neoplasms
- Neoplasms
- 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
- Neoplasms
- Carcinoma
- Colorectal Neoplasms
- Esophageal Diseases
- Esophageal Neoplasms
- Ovarian Neoplasms
- Pancreatic Neoplasms
- Carcinoma, Hepatocellular
Name | Location |
|---|---|
| John Wayne Cancer Institute | Santa Monica, California 90404 |
