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A Phase I/II Study of Aroplatin™ in Patients With Advanced Solid Malignancies


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Esophageal Neoplasms, Hepatocellular Carcinoma, Colorectal Neoplasms, Ovarian Neoplasms, Pancreatic Neoplasms, Neoplasms

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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