Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00050687
Status:
TERMINATED
Last Update Posted:
2011-01-28
First Post:
2002-12-17
Brief Title:
Safety and Pharmacokinetics of Orally Administered Gallium Maltolate in Various Refractory Malignancies
Sponsor:
Titan Pharmaceuticals
Organization:
Titan Pharmaceuticals
Study Overview
Official Title:
A Randomized Serum Level-targeted Study Investigating the Safety and Pharmacokinetics of Orally Administered Gallium Maltolate in Patients With Various Refractory Malignancies
Status:
TERMINATED
Status Verified Date:
2006-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None