Prostatic NeoplasmsPhase 1/2NCT00050687
Safety and Pharmacokinetics of Orally Administered Gallium Maltolate in Various Refractory Malignancies
A Phase 1/2 study testing Gallium maltolate in people with Prostatic Neoplasms and Multiple Myeloma, run by Titan Pharmaceuticals at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostatic Neoplasms, Multiple Myeloma, Bladder Neoplasms
- What is being tested?
- Gallium maltolate
- How many people
- Not given
- Where
- 5 sitesUnited States
- Study dates
- Jun 2001to Mar 2005
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
California Cancer Care
Greenbrae, California, 94904
New York Presbyterian Hospital
New York, New York, 10021
Stanford University
Palo Alto, California, 94303
Southfield Oncology Institute
Southfield, Michigan, 48076
Highlands Oncology Group, PA
Springdale, Arkansas, 72764
About this study
Official title: A Randomized, Serum Level-targeted Study Investigating the Safety and Pharmacokinetics of Orally Administered Gallium Maltolate in Patients With Various Refractory Malignancies
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.
Read the 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.
- Conditions
- Prostatic Neoplasms, Multiple Myeloma, Bladder Neoplasms, Lymphoma
- Being tested
- Gallium maltolate
- Medical subject headings
- Prostatic Neoplasms, Multiple Myeloma, Urinary Bladder Neoplasms, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gallium maltolateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2002 (estimated)
- Study startJun 2001
- Primary completionMar 2005
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Titan Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00050687
- Sponsor's protocol ID
- TTP-370-01-01
- Status last verified
- Nov 2006
- First submitted
- 17 Dec 2002
- Last updated
- 28 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Serum Level-targeted Study Investigating the Safety and Pharmacokinetics of Orally Administered Gallium Maltolate in Patients With Various Refractory Malignancies
- ClinicalTrials.gov ID
- NCT00050687
- Acronym / sponsor ID
- TTP-370-01-01
- Conditions
- Prostatic Neoplasms, Multiple Myeloma, Bladder Neoplasms, Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- Titan PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2001
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 19 Dec 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gallium maltolate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Gallium maltolate in people with Prostatic Neoplasms and Multiple Myeloma, run by Titan Pharmaceuticals at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2011.