Safety and Pharmacokinetics of Orally Administered Gallium Maltolate in Various Refractory Malignancies
A Randomized, Serum Level-targeted Study Investigating the Safety and Pharmacokinetics of Orally Administered Gallium Maltolate in Patients With Various Refractory Malignancies
1 other identifier
interventional
N/A
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2001
Typical duration for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2001
CompletedFirst Submitted
Initial submission to the registry
December 17, 2002
CompletedFirst Posted
Study publicly available on registry
December 19, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2005
CompletedJanuary 28, 2011
November 1, 2006
3.8 years
December 17, 2002
January 21, 2011
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- % 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Highlands Oncology Group, PA
Springdale, Arkansas, 72764, United States
California Cancer Care
Greenbrae, California, 94904, United States
Stanford University
Palo Alto, California, 94303, United States
Southfield Oncology Institute
Southfield, Michigan, 48076, United States
New York Presbyterian Hospital
New York, New York, 10021, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 17, 2002
First Posted
December 19, 2002
Study Start
June 1, 2001
Primary Completion
March 1, 2005
Study Completion
March 1, 2005
Last Updated
January 28, 2011
Record last verified: 2006-11