Safety and Pharmacokinetics of Orally Administered Gallium Maltolate in Various Refractory Malignancies

January 21, 2011 updated by: Titan Pharmaceuticals

A Randomized, Serum Level-targeted Study Investigating the Safety and Pharmacokinetics of Orally Administered Gallium Maltolate in Patients With Various Refractory Malignancies

This study will test the safety, tolerance, and efficacy of different doses of oral gallium maltolate. Patients will receive oral gallium maltolate twice daily for 28-consecutive days followed by 14 days off treatment. This dosing cycle will be repeated. Adverse effects will be assessed and the levels of gallium in serum will be measured. Any effect of the drug on the cancer and any improvement in cancer-related symptoms will also be measured.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Gallium maltolate is an orally bioavailable form of gallium. This is a safety, pharmacokinetic and preliminary efficacy study. The primary objective of the study is to assess the safety profile in patients after oral administration of different doses of gallium maltolate for up to six 42-day cycles (28 days of gallium maltolate, followed by 14 days off treatment). In addition, serum concentrations of gallium and associated pharmacokinetic variables will be measured. From this information, an optimal dose will be selected for assessment of anti-tumor efficacy. The study assesses the effects of oral administration of gallium maltolate on pain resulting from bony metastasis, on biochemical measures of bone turnover, and on disease progression and overall survival in patients with various refractory malignancies. Patients may receive up to 6 cycles of the investigational agent.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Springdale, Arkansas, United States, 72764
        • Highlands Oncology Group, PA
    • California
      • Greenbrae, California, United States, 94904
        • California Cancer Care
      • Palo Alto, California, United States, 94303
        • Stanford University
    • Michigan
      • Southfield, Michigan, United States, 48076
        • Southfield Oncology Institute
    • New York
      • New York, New York, United States, 10021
        • New York Presbyterian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with hormone refractory prostate cancer, refractory multiple myeloma, refractory bladder cancer, or malignant lymphoma;
  • life expectancy of ≥6 months,
  • Zubrod Performance Status of ≤2,
  • adequate bone marrow function, renal function, liver function and pulmonary function;
  • age ≥ 18 years;
  • willing and able to give informed consent; and
  • effective contraceptive use or non child-bearing potential.

Exclusion Criteria:

  • 10% weight loss in the previous 3 months;
  • active serious infection not controlled by antibiotics;
  • initiation of bisphosphonates treatment within 30 days;
  • participation in other research study within 30 days;
  • uncontrolled brain metastasis,
  • prior intrathecal chemotherapy or whole-brain radiotherapy,
  • inability to comply with protocol or undergo specified tests;
  • other active malignancy;
  • optic neuritis, and
  • routine use of diuretics (for initial phase of study only).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Titan Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2001

Primary Completion (Actual)

March 1, 2005

Study Completion (Actual)

March 1, 2005

Study Registration Dates

First Submitted

December 17, 2002

First Submitted That Met QC Criteria

December 18, 2002

First Posted (Estimate)

December 19, 2002

Study Record Updates

Last Update Posted (Estimate)

January 28, 2011

Last Update Submitted That Met QC Criteria

January 21, 2011

Last Verified

November 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TTP-370-01-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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