Know Cancer

or
forgot password

A Phase 1 Dose Escalation Study of the Safety and Pharmacokinetics of the KIT Inhibitor XL820 Administered Orally Daily to Subjects With Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Cancer

Thank you

Trial Information

A Phase 1 Dose Escalation Study of the Safety and Pharmacokinetics of the KIT Inhibitor XL820 Administered Orally Daily to Subjects With Solid Tumors


Inclusion Criteria:



- Subject has a histologically confirmed solid tumor that is metastatic or unresectable
for which known effective measures do not exist or are no longer effective, and there
are no known therapies to prolong survival

- Subject is at least 18 years old

- Subject has ECOG performance status ≤ 2

- Subject has a life expectancy of > 3 months

- Subject has adequate organ and marrow function

- In the adrenocorticotropic hormone (ACTH) stimulation test, the subject has a serum
cortisol level ≥ 20 ug/dL (552 nmol/L) 30-90 minutes after injection of ACTH

- Subject has given written informed consent

- Sexually active subjects (male and female) must use accepted methods of contraception
during the course of the study.

- Female subjects of childbearing potential must have a negative pregnancy test at
screening.

Exclusion Criteria:

- Subject has received anticancer treatment within 30 days before the first dose of
XL820, or has not recovered to grade ≤ 1 from adverse events due to agents
administered more than 30 days earlier

- Subject has received radiation to ≥ 25% of his/her bone marrow within 30 days of
XL820 treatment

- Subject has received an investigational agent within 30 days of the first dose of
XL820

- Subject has known brain metastases

- Subject has known uncontrolled intercurrent illness

- Subject is pregnant or lactating

- Subject is known to be positive for HIV

- Subject has a known allergy or hypersensitivity to any of the components of the XL820
formulation

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:

maximum tolerated dose

Authority:

United States: Food and Drug Administration

Study ID:

XL820-002

NCT ID:

NCT00350831

Start Date:

July 2006

Completion Date:

Related Keywords:

  • Cancer
  • Solid tumor

Name

Location

Cancer Therapy and Research CenterSan Antonio, Texas  78229
The Cancer Institute of New JerseyNew Brunswick, New Jersey  08901