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OpenTrials
Completed

NCT Number: NCT00336765

Study of XL647 Administered Orally Daily to Patients With Solid Tumors

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Stanford University Medical Center, Stanford, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

XL647

Drug

Tablets supplied in 50-mg strength administered orally daily

Other names: KD019

Primary outcomes

  1. Evaluate safety, tolerability, and maximum tolerated dose of XL647

    Time frame: Inclusion until 30 days post last treatment

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Kadmon Corporation, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Jun 14, 2006
Registry last updated
May 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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