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

Tracking Information
First Received Date ^ICMJE	December 17, 2002
Last Updated Date	August 19, 2008
Start Date ^ICMJE	June 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00050687 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Safety and Pharmacokinetics of Orally Administered Gallium Maltolate in Various Refractory Malignancies
Official Title ^ICMJE	A Randomized, Serum Level-Targeted Study Investigating the Safety and Pharmacokinetics of Orally Administered Gallium Maltolate in Patients With Various Refractory Malignancies
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 Phase	Phase I, Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Condition ^ICMJE	Prostatic Neoplasms Multiple Myeloma Bladder Neoplasms Lymphoma
Intervention ^ICMJE	Drug: Gallium maltolate
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE
Completion Date	February 2005
Primary Completion Date
Eligibility Criteria ^ICMJE	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).
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00050687
Responsible Party
Study ID Numbers ^ICMJE	TTP-370-01-01
Study Sponsor ^ICMJE	Titan Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Titan Pharmaceuticals
Verification Date	November 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP