Clinical trial · Interventional
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
NCT00336765CI-TRIAL-00058471completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| XL647 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Evaluate safety, tolerability, and maximum tolerated dose of XL647
- timeFrame
- Inclusion until 30 days post last treatment
Secondary outcomes (2)
- measure
- Characterize pharmacokinetics and pharmacodynamic effects of XL647
- timeFrame
- At various time points from pre-dosing until post dosing
- measure
- Evaluate preliminary tumor response
- timeFrame
- Inclusion until disease progression
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDDas 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 30030583