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Study of XL647 Administered Orally Daily to Patients With Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00336765
Recruitment Status : Completed
First Posted : June 14, 2006
Last Update Posted : October 18, 2011
Information provided by (Responsible Party):
Kadmon Corporation, LLC

Brief Summary:
The purpose of this study is to assess the safety and tolerability of the multiple receptor tyrosine kinase (RTK) inhibitor (including EGFR, VEGFR2, ErbB2, and EphB4) XL647 when given orally daily to adults with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Cancer Drug: XL647 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL647 Administered Orally Daily to Subjects With Solid Tumors
Study Start Date : July 2006
Primary Completion Date : August 2010
Study Completion Date : September 2010

Intervention Details:
    Drug: XL647
    Tablets supplied in 50-mg strength administered orally daily
    Other Name: KD019

Primary Outcome Measures :
  1. Evaluate safety, tolerability, and maximum tolerated dose of XL647 [ Time Frame: Inclusion until 30 days post last treatment ]

Secondary Outcome Measures :
  1. Characterize pharmacokinetics and pharmacodynamic effects of XL647 [ Time Frame: At various time points from pre-dosing until post dosing ]
  2. Evaluate preliminary tumor response [ Time Frame: Inclusion until disease progression ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00336765

United States, California
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Kadmon Corporation, LLC

Responsible Party: Kadmon Corporation, LLC Identifier: NCT00336765     History of Changes
Other Study ID Numbers: XL647-002
First Posted: June 14, 2006    Key Record Dates
Last Update Posted: October 18, 2011
Last Verified: October 2011

Keywords provided by Kadmon Corporation, LLC:
solid tumors