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Study of XL647 Administered Orally Daily to Patients With Solid Tumors

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Kadmon

Status and phase

Completed
Phase 1

Conditions

Cancer

Treatments

Drug: XL647

Study type

Interventional

Funder types

Industry

Identifiers

NCT00336765
XL647-002

Details and patient eligibility

About

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.

Enrollment

31 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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