Study of XL820 Given Orally Daily to Subjects With Solid Tumors

Exelixis

Status and phase

Completed

Phase 1

Conditions

Cancer

Treatments

Drug: XL820

Study type

Interventional

Funder types

Industry

Identifiers

NCT00350831

XL820-002

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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