NCT00336765CompletedPhase 1
A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL647 Administered Orally Daily to Subjects With Solid Tumors
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Kadmon Corporation, LLC
- Enrollment
- 31
- Locations
- 2
- Primary Endpoint
- Evaluate safety, tolerability, and maximum tolerated dose of XL647
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Evaluate safety, tolerability, and maximum tolerated dose of XL647
Time Frame: Inclusion until 30 days post last treatment
Secondary Outcomes
- 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)
Investigators
Study Sites (2)
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