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A Randomized, Serum Level-targeted Study Investigating the Safety and Pharmacokinetics of Orally Administered Gallium Maltolate in Patients With Various Refractory Malignancies


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Prostatic Neoplasms, Multiple Myeloma, Bladder Neoplasms, Lymphoma

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Trial Information

A Randomized, Serum Level-targeted Study Investigating the Safety and Pharmacokinetics of Orally Administered Gallium Maltolate in Patients With Various Refractory Malignancies


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.


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).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

TTP-370-01-01

NCT ID:

NCT00050687

Start Date:

June 2001

Completion Date:

March 2005

Related Keywords:

  • Prostatic Neoplasms
  • Multiple Myeloma
  • Bladder Neoplasms
  • Lymphoma
  • Urinary Bladder Neoplasms
  • Neoplasms
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Prostatic Neoplasms

Name

Location

Stanford UniversityStanford, California  94305
California Cancer CareGreenbrae, California  94904
Highlands Oncology Group, PASpringdale, Arkansas  72764
Southfield Oncology InstituteSouthfield, Michigan  48076
New York Presbyterian HospitalNew York, New York  10021