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
1 other identifier
interventional
31
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 cancer
Started Jul 2006
Typical duration for phase_1 cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2006
CompletedFirst Posted
Study publicly available on registry
June 14, 2006
CompletedStudy Start
First participant enrolled
July 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedMay 13, 2022
May 1, 2022
4.1 years
June 12, 2006
May 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate safety, tolerability, and maximum tolerated dose of XL647
Inclusion until 30 days post last treatment
Secondary Outcomes (2)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Stanford University Medical Center
Stanford, California, 94305, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Related Publications (1)
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.
PMID: 30030583BACKGROUND
MeSH Terms
Conditions
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2006
First Posted
June 14, 2006
Study Start
July 1, 2006
Primary Completion
August 1, 2010
Study Completion
September 1, 2010
Last Updated
May 13, 2022
Record last verified: 2022-05