Clinical trial · Interventional
A VX-680 (an Aurora Kinase Inhibitor) Study in Patients With Advanced Cancer (0457-002)
A Phase I Dose Escalation Study of MK0457 Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a 24-Hour Continuous Infusion Given Every 21 Days in Patients With Advanced Cancer
- 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 MK-0457(VX-680), an Aurora kinase inhibitor, in participants with advanced solid tumors. Bioavailability of the oral formulation will also be assessed. The primary study hypothesis is that administration of MK-0457 is sufficiently safe and tolerated to permit further study.
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 |
|---|---|---|---|
| MK-0457 | Drug | Tozasertib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MK-0457
- description
- Participants received MK-0457 at assigned dose as a continuous intravenous infusion (CIV) over 24 hours; one group of participants also received MK-0457 100 mg capsules, orally, prior to the CIV.
- interventionNames
- Drug: MK-0457
Primary outcomes (1)
- measure
- Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
- timeFrame
- Up to 21 days
Secondary outcomes (2)
- measure
- Change in standard uptake value (SUV) in fluorodeoxyglucose positron emission tomography (FDG-PET) scans
- timeFrame
- Predose, and at end of Cycles 2 and 6 (up to approximately 4 months)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who are at least 18 years of age with recurrent or non-responsive solid tumors, or cancers for which standard therapy does not exist. Exclusion Criteria: * Patients who have had treatment with any investigational therapy within the past 30 days. * Patients who have certain types of blood cancers such as leukemia or lymphoma. * Patients who have uncontrolled congestive heart failure (CHF), chest pains, or had a heart attack within the past 3 months, or have undergone bone marrow or stem cell transplantation. * Patient is pregnant or nursing.
References
Publications (1)
- DERIVEDTraynor AM, Hewitt M, Liu G, Flaherty KT, Clark J, Freedman SJ, Scott BB, Leighton AM, Watson PA, Zhao B, O'Dwyer PJ, Wilding G. Phase I dose escalation study of MK-0457, a novel Aurora kinase inhibitor, in adult patients with advanced solid tumors. Cancer Chemother Pharmacol. 2011 Feb;67(2):305-14. doi: 10.1007/s00280-010-1318-9. Epub 2010 Apr 13. PMID 20386909