A Safety and Effectiveness Study of Aroplatin in Patients With Advanced Solid Malignancies

Aronex Pharmaceuticals40 enrolled

Overview

To determine the rate of response and the duration of the response following therapy with Aroplatinin 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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Esophageal Neoplasms Hepatocellular Carcinoma Colorectal Neoplasms Ovarian Neoplasms Pancreatic Neoplasms Neoplasms

Interventions

Aroplatin (Liposomal NDDP, L-NDDP)DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

John Wayne Cancer Institute

Santa Monica, California, United States

Data from ClinicalTrials.gov

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