Clinical trial · Interventional
Vatalanib and Everolimus in Treating Patients With Advanced Solid Tumors
PTK787/ZK222584 and RAD001 for Patients With Advanced Solid Tumors
NCT00303732CI-TRIAL-00021216PTK/RADcompletedPhase 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)
RATIONALE: Vatalanib and everolimus may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of vatalanib and everolimus and to see how well they work in treating patients with advanced solid tumors.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PTK787 (vatalanib) | Drug | Vatalanib | ALIAS |
| RAD001 (everolimus) | Drug | Everolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PTK787, RAD001
- description
- PTK787 (vatalinib) 1000 mg daily, RAD001 (everolimus) 5 mg daily
- interventionNames
- Drug: RAD001 (everolimus)
- Drug: PTK787 (vatalanib)
Primary outcomes (3)
- measure
- Maximum tolerated dose (MTD) of vatalanib and everolimus
- timeFrame
- Day 1 - 28
- description
- Patients were evaluated on Day 1,14 and 28 for dose limiting toxicities
- measure
- Safety and tolerability
- timeFrame
- Duration of study treatment
- description
- Adverse events were assessed every 14 days for the length of the treatment period.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed solid tumor with radiographic evidence of metastatic disease * No standard therapy exists (phase I) * Unresectable or metastatic renal cell carcinoma (phase Ib) PATIENT CHARACTERISTICS: * Karnofsky performance status 70-100% * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 9 g/dL * AST or ALT ≤ 2.5 times upper limit of normal (ULN) * Total cholesterol \< 300 mg/dL * Triglycerides \< 350 mg/dL * Bilirubin ≤ 1.5 times ULN * Creatinine ≤ 1.5 times ULN OR creatinine clearance \> 40 mL/min * Negative proteinuria by dip stick OR total urinary protein ≤ 500 mg * No uncontrolled high blood pressure, history of labile hypertension, or history of poor compliance with antihypertensive regimen * No unstable angina pectoris * No symptomatic congestive heart failure (New York Heart Association class III or IV heart disease) * No uncontrolled serious cardiac arrhythmia (symptomatic supraventricular tachycardia or any ventricular tachycardia/fibrillation) * No myocardial infarction in the past 6 months * No uncontrolled diabetes * No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung * No active or uncontrolled infection * No uncontrolled hyperlipidemia * No chronic renal disease * No acute or chronic liver disease (e.g., hepatitis or cirrhosis) * No impaired gastrointestinal (GI) function OR GI disease that may significantly alter the absorption of vatalanib or everolimus, including any of the following: * Ulcerative disease * Uncontrolled nausea and vomiting with solid food * Watery diarrhea \> 5 times daily * Malabsorption syndrome * Bowel obstruction * Inability to swallow the tablets * No confirmed HIV infection * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception * No other concurrent severe and/or uncontrolled medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: * Recovered from prior therapy * No prior antivascular endothelial growth factor therapy * More than 4 weeks since prior major surgery\* (laparotomy) * More than 2 weeks since prior minor surgery\* * More than 4 weeks since prior chemotherapy (6 weeks for mitomycin C or nitrosoureas) * More than 6 weeks since prior antibody therapy * More than 2 weeks since prior biologic/immunotherapy * More than 2 weeks since prior limited-field radiotherapy * More than 4 weeks since prior full-field radiotherapy * More than 4 weeks since prior investigational agents * Prior transfusions allowed provided blood counts are stable for \> 2 weeks * Concurrent epoetin alfa allowed * No concurrent warfarin or similar oral anticoagulants that are metabolized by the cytochrome P450 system * Heparin and low molecular weight heparin allowed NOTE: \*Insertion of a vascular access device is not considered major or minor surgery
References
Publications (1)
- RESULTSpeca JC, Mears AL, Creel PA, et al.: Phase I study of PTK787/ZK222584 (PTK/ZK) and RAD001 for patients with advanced solid tumors and dose expansion in renal cell carcinoma patients. [Abstract] J Clin Oncol 25 (Suppl 18): A-5039, 244s, 2007.