NCT00350831

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2006

Completed
Last Updated

August 18, 2008

Status Verified

August 1, 2008

First QC Date

July 7, 2006

Last Update Submit

August 14, 2008

Conditions

Cancer

Keywords

Solid tumor

Outcome Measures

Primary Outcomes (2)

  • maximum tolerated dose

  • safety and tolerability

Secondary Outcomes (3)

  • plasma pharmacokinetics

  • pharmacodynamic effects

  • long-term safety and tolerability

Interventions

XL820DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Cancer Therapy and Research Center

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 7, 2006

First Posted

July 11, 2006

Study Start

July 1, 2006

Last Updated

August 18, 2008

Record last verified: 2008-08

Locations

US(2)