Study of XL647 Administered Orally Daily to Patients With Solid Tumors

NCT ID: NCT00336765

Last Updated: 2022-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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XL647

Tablets supplied in 50-mg strength administered orally daily

Intervention Type DRUG

Other Intervention Names

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KD019

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kadmon Corporation, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Stanford University Medical Center

Stanford, California, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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Das M, Padda SK, Frymoyer A, Molina J, Adjei A, Lensing JL, Miles D, Sikic BI, Wakelee HA. A safety, tolerability, and pharmacokinetic analysis of two phase I studies of multitargeted small molecule tyrosine kinase inhibitor XL647 with an intermittent and continuous dosing schedule in patients with advanced solid malignancies. Cancer Chemother Pharmacol. 2018 Sep;82(3):541-550. doi: 10.1007/s00280-018-3646-0. Epub 2018 Jul 20.

Reference Type BACKGROUND
PMID: 30030583 (View on PubMed)

Other Identifiers

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XL647-002

Identifier Type: -

Identifier Source: org_study_id

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