A Phase 1 Study In Patients With Advanced Solid Tumor To Evaluate The Pharmacokinetics And Safety Of AG-013736 At Single Doses Of 5 mg, 7 mg And 10 mg, And At Multiple Doses
Phase 1
20 Years
N/A
20 Years
N/A
Not Enrolling
Both
Neoplasms
Both
Neoplasms
Trial Information
A Phase 1 Study In Patients With Advanced Solid Tumor To Evaluate The Pharmacokinetics And Safety Of AG-013736 At Single Doses Of 5 mg, 7 mg And 10 mg, And At Multiple Doses
Inclusion Criteria:
- Patients histologically or cytologically diagnosed with advanced solid tumors
- Patients for whom standard therapies have not been effective, or for whom there are
no suitable therapies
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1 or 2
- Patients with no uncontrolled hypertension
Exclusion Criteria:
- Patients who have central lung lesions involving major blood vessels
- Patients who require anticoagulant therapy.
- Patients with active epilepsy seizure or symptoms, with brain metastases requiring
treatment, with spinal cord compression and with carcinomatous meningitis.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Single Dose: Maximum Observed Plasma Concentration (Cmax)
Outcome Time Frame:
Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
A4061044
NCT ID:
NCT00726752
Start Date:
July 2008
Completion Date:
April 2010
Related Keywords:
- Neoplasms
- solid tumor
- Axitinib
- Pharmacokinetics
- Phase 1
- Neoplasms
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