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

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Primary Purpose

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Aroplatin (Liposomal NDDP, L-NDDP)

About this trial

This is an interventional treatment trial for Esophageal Neoplasms focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

John Wayne Cancer Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00057395

First Posted

April 1, 2003

Last Updated

June 23, 2005

Sponsor

Aronex Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00057395

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2004

Overall Recruitment Status

Unknown status

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Aronex Pharmaceuticals

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Neoplasms, Hepatocellular Carcinoma, Colorectal Neoplasms, Ovarian Neoplasms, Pancreatic Neoplasms, Neoplasms

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Aroplatin (Liposomal NDDP, L-NDDP)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Facility Information:

Facility Name

John Wayne Cancer Institute

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Esophageal Neoplasms, Hepatocellular Carcinoma, Colorectal Neoplasms

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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