Cancer
Conditions
Keywords
Solid tumor
Brief summary
The purpose of this study is to assess the safety and tolerability of the KIT inhibitor XL820 when given orally daily to adults with advanced solid tumors.
Interventions
DRUGXL820
Sponsors
Exelixis
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| maximum tolerated dose | — |
| safety and tolerability | — |
Secondary
| Measure | Time frame |
|---|---|
| plasma pharmacokinetics | — |
| pharmacodynamic effects | — |
| long-term safety and tolerability | — |
Countries
United States
Outcome results
None listed