Clinical trial · Interventional
PTK787/ZK 222584 in Combination With Temozolomide and Radiation in Patients With Glioblastoma Taking Enzyme-Inducing Anti-Epileptic Drugs
A Phase I Study of PRK787/ZK 222584 in Combination With Daily Temozolomide and Radiation in Patients With Newly Diagnosed Glioblastoma
- 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)
PTK is an investigational new drug that has been shown in early laboratory studies to prevent the formation of new blood vessels that allow the tumor to grow. These studies have shown that the study drug can potentially improve the effectiveness of additional radiation and chemotherapy. With this study, we would like to examine the effects of PTK when used in combination with radiation therapy and the anti-cancer drug temozolomide, the standard treatment for patients with newly diagnosed glioblastoma. We would also like to learn how the study drug is absorbed, distributed, and cleared from the body.
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 |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PTK787/ZK 222584 | Drug | Vatalanib | ALIAS |
| Radiation Therapy | Procedure | — | UNRESOLVED |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PTK787
- description
- Single arm study of PTK787
- interventionNames
- Drug: PTK787/ZK 222584
- Drug: Temozolomide
- Procedure: Radiation Therapy
Primary outcomes (1)
- measure
- To determine the maximal tolerated dose, safety and feasibility of PTK787/ZK 222584 in combination with temozolomide and radiation in patients with newly diagnosed glioblastoma.
- timeFrame
- 2 years
Secondary outcomes (2)
- measure
- Determine the pharmacologic profile of PTK787/ZK 222584 in this patient population
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All patients must have histologically verified glioblastoma. Patients mus have paraffin blocks of tumor that must be sent for analysis. * 18 years of age or older * Karnofsky Performance Status greater than or equal to 60 * Adequate laboratory values as described by the protocol * Life expectancy of greater than 12 weeks * Patient must be able to undergo serial MR imaging * Patients must be on an enzyme-inducing anti-epileptic drug(s) as listed in the protocol * No steroids or a stable dose of steroids for at least 5 days or a decreasing dose * Mini-mental status examination of 15 or greater Exclusion Criteria: * Pregnant or breast-feeding women * Concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast * Prior chemotherapy or cranial radiation therapy for glioblastoma * Prior biologic or immunotherapy less than 2 weeks prior to registration * If the patient surgery is more than 16 days or less than 13 days from the start of PTK787/ZK 222854 * Prior therapy with anti-VEGF agents * Pleural effusion or ascites that causes respiratory compromise * Concurrent severe and/or uncontrolled medical conditions which could compromise participation is the study * Impairment of gastrointestinal function or GI disease that may significantly alter the absorption of PTK787/ZK 222584 * Confirmed diagnosis of human immunodeficiency virus (IV) * Patients who are taking therapeutic warfarin sodium or other anticoagulants or anti-platelet agents * Patients requiring aprepitant, dolasetron, and tropisetron as antiemetics are excluded
References
Publications (1)
- RESULTGerstner ER, Eichler AF, Plotkin SR, Drappatz J, Doyle CL, Xu L, Duda DG, Wen PY, Jain RK, Batchelor TT. Phase I trial with biomarker studies of vatalanib (PTK787) in patients with newly diagnosed glioblastoma treated with enzyme inducing anti-epileptic drugs and standard radiation and temozolomide. J Neurooncol. 2011 Jun;103(2):325-32. doi: 10.1007/s11060-010-0390-7. Epub 2010 Sep 7. PMID 20821342