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

Part of paid clinical trials in Springdale, Arkansas.

Sponsor
Titan Pharmaceuticals
Study ID
NCT00050687
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jun 30, 2001
Status verified
Nov 2006
Primary completion
Mar 31, 2005
Completion
Mar 31, 2005

Study Design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Locations (5)

FacilityCityStateZIPSite coordinators
Highlands Oncology Group, PASpringdaleArkansas72764-
California Cancer CareGreenbraeCalifornia94904-
Stanford UniversityPalo AltoCalifornia94303-
Southfield Oncology InstituteSouthfieldMichigan48076-
New York Presbyterian HospitalNew YorkNew York10021-

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Highlands Oncology Group, PA· Springdale, ARCalifornia Cancer Care· Greenbrae, CAStanford University· Palo Alto, CASouthfield Oncology Institute· Southfield, MINew York Presbyterian Hospital· New York, NY

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