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Sponsored by: |
Titan Pharmaceuticals |
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Information provided by: | Titan Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00050687 |
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 | Intervention | Phase |
---|---|---|
Prostatic Neoplasms Multiple Myeloma Bladder Neoplasms Lymphoma |
Drug: Gallium maltolate |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
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: | June 2001 |
Estimated Study Completion Date: | February 2005 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arkansas | |
Highlands Oncology Group, PA | |
Springdale, Arkansas, United States, 72764 | |
United States, California | |
Stanford University | |
Palo Alto, California, United States, 94303 | |
California Cancer Care | |
Greenbrae, California, United States, 94904 | |
United States, Michigan | |
Southfield Oncology Institute | |
Southfield, Michigan, United States, 48076 | |
United States, New York | |
New York Presbyterian Hospital | |
New York, New York, United States, 10021 |
Study ID Numbers: | TTP-370-01-01 |
Study First Received: | December 17, 2002 |
Last Updated: | August 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00050687 |
Health Authority: | United States: Food and Drug Administration |
Genital Neoplasms, Male Prostatic Diseases Blood Protein Disorders Urogenital Neoplasms Paraproteinemias Urologic Neoplasms Hemostatic Disorders Hemorrhagic Disorders Urologic Diseases Multiple myeloma Lymphoma Bladder neoplasm Immunoproliferative Disorders |
Cystocele Hematologic Diseases Blood Coagulation Disorders Urinary Bladder Diseases Urinary Bladder Neoplasms Vascular Diseases Genital Diseases, Male Multiple Myeloma Lymphatic Diseases Lymphoproliferative Disorders Prostatic Neoplasms Urinary tract neoplasm Neoplasms, Plasma Cell |
Neoplasms Neoplasms by Histologic Type Neoplasms by Site Immune System Diseases Cardiovascular Diseases |