Study of XL820 Given Orally Daily to Subjects With Solid Tumors - Full Text View

Sponsor:	Exelixis
Information provided by:	Exelixis
ClinicalTrials.gov Identifier:	NCT00350831

Purpose

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.

Condition	Intervention	Phase
Cancer	Drug: XL820	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Exelixis:

Primary Outcome Measures:

maximum tolerated dose
safety and tolerability

Secondary Outcome Measures:

plasma pharmacokinetics
pharmacodynamic effects
long-term safety and tolerability

Estimated Enrollment:	30
Study Start Date:	July 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00350831

Locations

United States, New Jersey
The Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
United States, Texas
Cancer Therapy and Research Center
San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Exelixis

More Information

No publications provided

Study ID Numbers:	XL820-002
Study First Received:	July 7, 2006
Last Updated:	August 14, 2008
ClinicalTrials.gov Identifier:	NCT00350831 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Exelixis:

Solid tumor

ClinicalTrials.gov processed this record on November 05, 2009