Study of XL647 Administered Orally Daily to Patients With Solid Tumors

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00336765

Enrollment

Registered

2006-06-14

Start date

2006-07-31

Completion date

2010-09-30

Last updated

2022-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

solid tumors

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.

Interventions

DRUGXL647

Tablets supplied in 50-mg strength administered orally daily

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Evaluate safety, tolerability, and maximum tolerated dose of XL647	Inclusion until 30 days post last treatment

Secondary

Measure	Time frame
Characterize pharmacokinetics and pharmacodynamic effects of XL647	At various time points from pre-dosing until post dosing
Evaluate preliminary tumor response	Inclusion until disease progression

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026