Clinical trial · Interventional
AZD2171 in Treating Patients With Refractory Metastatic Kidney Cancer
A Phase 2 Study of AZD2171 in Patients With Advanced Renal Cell Carcinoma
NCT00303862CI-TRIAL-00014600terminatedPhase 2Results postedClinicalTrials.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)
This phase II trial is studying how well AZD2171 works in treating patients with refractory metastatic kidney cancer. AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Clear Cell Renal Cell Carcinoma | Clear Cell Renal Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Renal Cell Cancer | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Stage IV Renal Cell Cancer | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cediranib maleate | Drug | Cediranib | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (cediranib maleate)
- description
- Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: cediranib maleate
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Objective Response
- timeFrame
- Up to 6 weeks
- description
- Objective radiologic response as measured by RECIST criteria. (30% or greater shrinkage in the sum of the longest diameters of target lesions)
Secondary outcomes (3)
- measure
- Performance of DCE_MRI
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed clear cell renal cell cancer * Must be predominantly metastatic disease * Refractory disease * Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mmby conventional techniques or ≥ 10 mm by spiral CT scan * No known brain metastases * ECOG performance status 0-2 * Karnofsky 60-100% * WBC ≥ 3,000/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 8.0 g/dL * AST and ALT ≤ 2.5 times upper limit of normal (ULN) * Bilirubin normal * Creatinine normal OR creatinine clearance \> 60 mL/min * Blood pressure \< 140/90 mm Hg on 2 separate occasions not more than 6 weeks prior to enrollment and not less than 24 hours apart (stable antihypertensive regimen allowed) * Mean QTc ≤ 470 msec (with Bazett's correction) * Less than +1 proteinuria on two consecutive dipsticks taken no less than 1 week apart * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No history of familial long QT syndrome * No cardiac arrhythmia * No unstable angina pectoris * No symptomatic congestive heart failure * No New York Heart Association class III or IV disease * No ongoing or active infection * No hypertension * No other uncontrolled intercurrent illness * No history of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD2171 * No psychiatric illness or social situations that would limit compliance with study requirements * See Disease Characteristics * More than 4 weeks since prior radiotherapy and recovered * More than 4 weeks since prior major surgery and recovered * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered * More than 30 days since other prior investigational agents * No prior therapy with vascular endothelial growth factor (VEGF) binding agents or VEGF receptor (VEGFR) tyrosine kinase inhibitors * No more than 1 prior nonVEGF-directed systemic therapy for this disease * No concurrent medication that may markedly affect renal function (e.g., vancomycin, amphotericin, ibuprofen, pentamidine) * No combination antiretroviral therapy for HIV-positive patients * No concurrent hematopoietic growth factors except epoetin alfa and bisphosphonates * No concurrent hormones or other chemotherapeutic agents except for steroids given for adrenal failure and hormones administered for nondisease-related conditions (e.g. insulin for diabetes) * No concurrent palliative or therapeutic radiation therapy * No concurrent drugs or biologics with proarrhythmic potential * No other concurrent investigational or commercial agents or therapies to treat the patient's malignancy
References
Publications (0)
Data not yet available
No reference posted for this study.