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

Sponsor
Titan Pharmaceuticals (Industry)
Overall Status
Terminated
CT.gov ID
NCT00050687
Collaborator
(none)
5
Locations
45
Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Gallium maltolate
 Phase 1/Phase 2

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 Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Serum Level-targeted Study Investigating the Safety and Pharmacokinetics of Orally Administered Gallium Maltolate in Patients With Various Refractory Malignancies
Study Start Date :
Jun 1, 2001
Actual Primary Completion Date :
Mar 1, 2005
Actual Study Completion Date :
Mar 1, 2005

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Highlands Oncology Group, PA Springdale Arkansas United States 72764
    2 California Cancer Care Greenbrae California United States 94904
    3 Stanford University Palo Alto California United States 94303
    4 Southfield Oncology Institute Southfield Michigan United States 48076
    5 New York Presbyterian Hospital New York New York United States 10021

    Sponsors and Collaborators

    • Titan Pharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00050687
    Other Study ID Numbers:
    • TTP-370-01-01
    First Posted:
    Dec 19, 2002
    Last Update Posted:
    Jan 28, 2011
    Last Verified:
    Nov 1, 2006
    Additional relevant MeSH terms:
    Neoplasms
    Multiple Myeloma
    Prostatic Neoplasms
    Urinary Bladder Neoplasms

    Study Results

    No Results Posted as of Jan 28, 2011