A Randomized, Serum Level-targeted Study Investigating the Safety and Pharmacokinetics of Orally Administered Gallium Maltolate in Patients With Various Refractory Malignancies
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
United States: Food and Drug Administration
TTP-370-01-01
NCT00050687
June 2001
March 2005
Name | Location |
---|---|
Stanford University | Stanford, California 94305 |
California Cancer Care | Greenbrae, California 94904 |
Highlands Oncology Group, PA | Springdale, Arkansas 72764 |
Southfield Oncology Institute | Southfield, Michigan 48076 |
New York Presbyterian Hospital | New York, New York 10021 |