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A Phase 1 Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL999 Administered Intravenously to Subjects With Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

A Phase 1 Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL999 Administered Intravenously to Subjects With Solid Tumors


Inclusion Criteria:



- Advanced solid tumor

- Cancer that has progressed on currently available therapies

- Life expectancy of >3 months

- Adequate bone marrow, liver, and kidney function

- Willing to use accepted method of contraception during the course of the study

- Negative pregnancy test (females)

- Written informed consent

Exclusion Criteria:

- Chemotherapy within 4-6 weeks of the start of treatment (depending on the therapy)

- Radiotherapy within 4 weeks of the start of treatment

- Subjects with known brain metastasis

- Uncontrolled medical disorder such as infection or cardiovascular disease

- Subjects known to be HIV positive

- Pregnant or breastfeeding women

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine the maximum tolerated dose (MTD) and to assess the safety and tolerability of XL999 administered as a single 4-hour intravenous (IV) infusion in subjects with solid tumors

Outcome Time Frame:

Inclusion until 30 days post last treatment

Safety Issue:

Yes

Principal Investigator

Paul Woodard, MD

Investigator Role:

Study Director

Investigator Affiliation:

Exelixis, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

XL999-001

NCT ID:

NCT00104117

Start Date:

November 2004

Completion Date:

October 2008

Related Keywords:

  • Cancer

Name

Location

Cancer Therapy and Research Center, Institute for Drug DevelopmentSan Antonio, Texas  78229
Case Western Reserve University, Univserzity Hospitals of ClevelandCleveland, Ohio  44106