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Safety and pharmacokinetics of orally administered gallium maltolate in various refractory malignancies. Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Safety and pharmacokinetics of orally administered gallium maltolate in various refractory malignancies. conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Safety and pharmacokinetics of orally administered gallium maltolate in various refractory malignancies. Clinical research trials and Safety and pharmacokinetics of orally administered gallium maltolate in various refractory malignancies. healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Safety and pharmacokinetics of orally administered gallium maltolate in various refractory malignancies.. Safety and pharmacokinetics of orally administered gallium maltolate in various refractory malignancies. Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Safety and pharmacokinetics of orally administered gallium maltolate in various refractory malignancies. clinical trial. Human subjects often obtain the finest healthcare possible for their Safety and pharmacokinetics of orally administered gallium maltolate in various refractory malignancies. condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Safety and pharmacokinetics of orally administered gallium maltolate in various refractory malignancies.  Safety and pharmacokinetics of orally administered gallium maltolate in various refractory malignancies.
Safety and pharmacokinetics of orally administered gallium maltolate in various refractory malignancies.
For Condition: Multiple Myeloma,Bladder Neoplasms,Prostatic Neoplasms,Lymphoma
Status: Recruiting
Sponsor(s): Titan Pharmaceuticals ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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).
Total Enrollment:
Location and Contact Information:
California Cancer Care *Recruiting*
Greenbrae, California, 94904
United States
Recruiting Jaime Chang 415-925-5040
Southfield Oncology Institute *Recruiting*
Southfield, Michigan, 48076
United States
Recruiting Sudha Sardesai 248-356-2828
Stanford University *Recruiting*
Palo Alto, California, 94303
United States
Recruiting Denise Haas 650-493-5000
New York Presbyterian Hospital *Recruiting*
New York City, New York, 10021
United States
Recruiting Jodi Kaplan 212-746-2920
Highlands Oncology Group, PA *Recruiting*
Springdale, Arkansas, 72764
United States
Recruiting Kim Davison 479-872-8130
Additional Information:
Study ID Numbers: TTP-370-01-01;
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00050687
Other Multiple Myeloma Studies:
1. TOCOSOL(TM) Paclitaxel in Metastatic or Locally Advanced, Unresectable Transitional Cell Carcinoma (TCC) of the Urothelium
2. Safety and pharmacokinetics of orally administered gallium maltolate in various refractory malignancies.
3. A Phase I Trial Using Suramin to Treat Superficial Transitional Cell Carcinoma of the Bladder
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Safety and pharmacokinetics of orally administered gallium maltolate in various refractory malignancies.
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