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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To determine the rate of response and the duration of the response following therapy with Aroplatinin patients with advanced solid malignancies.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Esophageal Neoplasms Hepatocellular Carcinoma Colorectal Neoplasms Ovarian Neoplasms Pancreatic Neoplasms Neoplasms

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Aroplatin (Liposomal NDDP, L-NDDP)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

John Wayne Cancer Institute

Santa Monica, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

C-726-04

Identifier Type: -

Identifier Source: org_study_id