Safety and Pharmacokinetics of Orally Administered Gallium Maltolate in Various Refractory Malignancies
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| ClinicalTrials.gov Identifier: NCT00050687 |
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Recruitment Status :
Terminated
First Posted : December 19, 2002
Last Update Posted : January 28, 2011
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Sponsor:
Titan Pharmaceuticals
Information provided by:
Titan Pharmaceuticals
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Prostatic Neoplasms Multiple Myeloma Bladder Neoplasms Lymphoma | Drug: Gallium maltolate | Phase 1 Phase 2 |
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 Type : | Interventional (Clinical Trial) |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 Start Date : | June 2001 |
| Actual Primary Completion Date : | March 2005 |
| Actual Study Completion Date : | March 2005 |
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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).
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00050687
Locations
| United States, Arkansas | |
| Highlands Oncology Group, PA | |
| Springdale, Arkansas, United States, 72764 | |
| United States, California | |
| California Cancer Care | |
| Greenbrae, California, United States, 94904 | |
| Stanford University | |
| Palo Alto, California, United States, 94303 | |
| United States, Michigan | |
| Southfield Oncology Institute | |
| Southfield, Michigan, United States, 48076 | |
| United States, New York | |
| New York Presbyterian Hospital | |
| New York, New York, United States, 10021 | |
Sponsors and Collaborators
Titan Pharmaceuticals
| ClinicalTrials.gov Identifier: | NCT00050687 |
| Other Study ID Numbers: |
TTP-370-01-01 |
| First Posted: | December 19, 2002 Key Record Dates |
| Last Update Posted: | January 28, 2011 |
| Last Verified: | November 2006 |
Additional relevant MeSH terms:
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Neoplasms Multiple Myeloma Prostatic Neoplasms Urinary Bladder Neoplasms Neoplasms, Plasma Cell Neoplasms by Histologic Type Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases |
Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Prostatic Diseases Urologic Neoplasms Urinary Bladder Diseases Urologic Diseases |