Clinical trial · Interventional
Safety and Pharmacokinetics of XL647 Administered Orally to Subjects With Solid Tumors
A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL647 Administered Orally to Subjects With Solid Tumors
- 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 primary objective of this study is as follows: * To evaluate the safety and tolerability of XL647 administered orally as a single dose and as repeat doses in subjects with solid tumors. The secondary objectives of this study are as follows: * To evaluate the plasma pharmacokinetics of XL647 administered orally as a single dose and as repeat doses in subjects with solid tumors, * To estimate renal elimination of XL647 administered orally as a single dose in subjects with solid tumors. The exploratory objective of this study is as follows: * To assess the pharmacodynamic effects of XL647 administration in plasma and peripheral blood cells. In addition, subjects may be eligible to enter a Treatment Extension Period. The following information will be obtained from this part of the study: * Long-term safety and tolerability of XL647 after repeat administration, * Tumor response after repeat administration of XL647.
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
- To evaluate the safety and tolerability of XL647 administered orally as a single dose and as repeat doses
- timeFrame
- First treatment until 30 days post last treatment
Secondary outcomes (2)
- measure
- To evaluate the plasma pharmacokinetics of XL647 administered orally as a single dose and as repeat dose
- timeFrame
- At various time points between pre-treatment and post last treatment
- measure
- To estimate renal elimination of XL647 administered orally as a single dose in subjects with solid tumors
- timeFrame
- At various time points between pre-treatment and post last treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * The subject has a histologically confirmed malignancy that is metastatic or unresectable, and for which standard curative or palliative measures do not exist or are no longer effective, * The subject has disease that is assessable by tumor marker, physical, or radiologic means, * The subject is ≥18 years old, * There have been at least 4 weeks since prior chemotherapy or radiation therapy (6 weeks if the last treatment regimen included BCNU or mitomycin C), * The subject has an ECOG performance status ≤2 (Karnofsky \>60%), * The subject has a life expectancy of ≥3 months, * The subject has normal organ and marrow function (hemoglobin \>10g/dL, leukocytes \>3,000/mL, absolute neutrophil count \>1,500/µL, platelets \>100,000/µL, total bilirubin within normal institutional limits of normal,AST (SGOT)/ALT(SGPT) \<2.5 times the upper limit of normal, and creatinine within normal limits, * The subject is capable of understanding and complying with the protocol and has signed the informed consent document, * Sexually active subjects (both male and female) must use an accepted method of contraception during the course of the study, * Female subjects of childbearing potential (pre-menopausal) must have a negative pregnancy test. Exclusion Criteria: * The subject has had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or has not recovered from AEs due to agents administered more than 4 weeks earlier, * The subject has received another investigational agent within 30 days (or 5.5 half-lives) of the first dose of study drug, * The subject has known brain metastases, * The subject has a corrected QT interval (QTc) of \>0.44 seconds, * The subject has a history of allergic reactions attributed to aspartame or to any other component in the formulation vehicle, * The subject has an uncontrolled intercurrent illness including,but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, * The subject is pregnant or nursing, * The subject is known to be positive for the human immunodeficiency virus (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