Know Cancer

or
forgot password

Phase I, Open-Label, Multicenter, Dose-Escalation Study Of The Tyrosine Kinase Inhibitor Of VEGFR-2, AG013736, In Patients With Advanced Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors

Thank you

Trial Information

Phase I, Open-Label, Multicenter, Dose-Escalation Study Of The Tyrosine Kinase Inhibitor Of VEGFR-2, AG013736, In Patients With Advanced Solid Tumors


Inclusion Criteria:



- Patients with cytologically or histologically confirmed solid tumor(s) and with at
least one measurable disease site

- Patients with adequate bone marrow, liver and kidney function

- Patients with life expectancy of at least 12 weeks

Exclusion Criteria:

- Patients who have received chemotherapy, immunotherapy, radiotherapy or any
investigational agent within 4 weeks of study entry

- Patients with have had a major surgical procedure within 4 weeks of study entry

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD)

Outcome Description:

MTD is defined as the dose level at which "no more than 1 of 6 participants experience dose-limiting toxicity (DLT) following de-escalation from the maximum administered dose (MAD)." DLT includes grade (Gr) 2 or greater gastrointestinal toxicities, Gr 3 anemia, nonhematological toxicities (excluding nausea, vomiting, and diarrhea) or Gr 4 neutropenia, thrombocytopenia and inability to resume axitinib (AG-013736) dosing within 14 days of stopping due to treatment related toxicity.

Outcome Time Frame:

Baseline up to Day 28

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

AG013736-001

NCT ID:

NCT01469052

Start Date:

November 2002

Completion Date:

August 2004

Related Keywords:

  • Advanced Solid Tumors
  • Neoplasms

Name

Location

Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteMilwaukee, Wisconsin  53215