Study of XL647 Administered Orally Daily to Patients With Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kadmon Corporation, LLC
ClinicalTrials.gov Identifier:
NCT00336765
First received: June 12, 2006
Last updated: October 17, 2011
Last verified: October 2011
  Purpose

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 Intervention Phase
Cancer
Drug: XL647
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 XL647 Administered Orally Daily to Subjects With Solid Tumors

Resource links provided by NLM:


Further study details as provided by Kadmon Corporation, LLC:

Primary Outcome Measures:
  • Evaluate safety, tolerability, and maximum tolerated dose of XL647 [ Time Frame: Inclusion until 30 days post last treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Characterize pharmacokinetics and pharmacodynamic effects of XL647 [ Time Frame: At various time points from pre-dosing until post dosing ] [ Designated as safety issue: No ]
  • Evaluate preliminary tumor response [ Time Frame: Inclusion until disease progression ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: July 2006
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: XL647
    Tablets supplied in 50-mg strength administered orally daily
    Other Name: KD019
  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00336765

Locations
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
  More Information

No publications provided

Responsible Party: Kadmon Corporation, LLC
ClinicalTrials.gov Identifier: NCT00336765     History of Changes
Other Study ID Numbers: XL647-002
Study First Received: June 12, 2006
Last Updated: October 17, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Kadmon Corporation, LLC:
solid tumors

ClinicalTrials.gov processed this record on October 23, 2014