Study of XL820 Given Orally Daily to Subjects With Solid Tumors

This study has been completed.
Sponsor:
Information provided by:
Exelixis
ClinicalTrials.gov Identifier:
NCT00350831
First received: July 7, 2006
Last updated: August 14, 2008
Last verified: August 2008
  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 1

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


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

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

Keywords provided by Exelixis:
Solid tumor

ClinicalTrials.gov processed this record on April 15, 2014