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A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL647 Administered Orally Daily to Subjects With Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Cancer

Thank you

Trial Information

A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL647 Administered Orally Daily to Subjects With Solid Tumors


Inclusion Criteria:



- Subject has histologically confirmed malignancy that is metastatic or unresectable

- Subject has disease that is assessable by tumor marker, physical, or radiologic means

- Subject is at least 18 years old

- Subject has an ECOG performance status ≤ 2 (Karnofsky ≥ 60%)

- Subject has a life expectancy ≥ 3 months

- Subject has normal organ and marrow function

- Subject gives written informed consent

- Subject must use an accepted method of contraception during the study

- Female subjects of childbearing potential must have a negative pregnancy test

Exclusion Criteria:

- Subject has received anticancer treatment within 30 days of first dose of XL647

- Subject has received another investigational agent within 30 days of first dose of
XL647

- Subject has known brain metastases

- Subject has corrected QT interval (QTc) of > 0.45 seconds

- Subject is currently receiving anticoagulation therapy with warfarin

- Subject has uncontrolled intercurrent illness

- Subject is pregnant or breastfeeding

- Subject has known HIV

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Evaluate safety, tolerability, and maximum tolerated dose of XL647

Outcome Time Frame:

Inclusion until 30 days post last treatment

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

XL647-002

NCT ID:

NCT00336765

Start Date:

July 2006

Completion Date:

September 2010

Related Keywords:

  • Cancer
  • solid tumors

Name

Location

Mayo ClinicRochester, Minnesota  55905
Stanford University Medical CenterStanford, California  94305-5408