Study of XL820 Given Orally Daily to Subjects With Solid Tumors

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00350831
• Other study ID #: XL820-002
• Status: Completed
• Phase: Phase 1
• First received: July 7, 2006
• Last updated: August 14, 2008
• Start date: July 2006

Study information

• Verified date: August 2008
• Source: Exelixis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• XL820

Locations

Country	Name	City	State
United States	The Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Cancer Therapy and Research Center	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Exelixis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maximum tolerated dose
Primary	safety and tolerability
Secondary	plasma pharmacokinetics
Secondary	pharmacodynamic effects
Secondary	long-term safety and tolerability