Back to resultsSafety and Pharmacokinetics of Orally Administered Gallium Maltolate in Various Refractory Malignancies
Primary Purpose
Prostatic Neoplasms, Multiple Myeloma, Bladder Neoplasms
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Gallium maltolate
Sponsored by
About this trial
This is an interventional treatment trial for Prostatic Neoplasms
Eligibility 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).
Sites / Locations
- Highlands Oncology Group, PA
- California Cancer Care
- Stanford University
- Southfield Oncology Institute
- New York Presbyterian Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00050687
First Posted
December 17, 2002
Last Updated
January 21, 2011
Sponsor
Titan Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00050687
Brief Title
Safety and Pharmacokinetics of Orally Administered Gallium Maltolate in Various Refractory Malignancies
Official Title
A Randomized, Serum Level-targeted Study Investigating the Safety and Pharmacokinetics of Orally Administered Gallium Maltolate in Patients With Various Refractory Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
November 2006
Overall Recruitment Status
Terminated
Study Start Date
June 2001 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
March 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Titan Pharmaceuticals
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms, Multiple Myeloma, Bladder Neoplasms, Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Gallium maltolate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Facility Information:
Facility Name
Highlands Oncology Group, PA
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72764
Country
United States
Facility Name
California Cancer Care
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94303
Country
United States
Facility Name
Southfield Oncology Institute
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48076
Country
United States
Facility Name
New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Pharmacokinetics of Orally Administered Gallium Maltolate in Various Refractory Malignancies
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