Clinical trial · Interventional
Neoadjuvant Pazopanib in Renal Cell Carcinoma
Neoadjuvant Pazopanib: A Phase II Study to Evaluate the Effect on Disease Response and Recurrence and to Establish Predictive Biomarkers of Drug Activity in Renal Cell Carcinoma
NCT01361113CI-TRIAL-00032676completedPhase 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 study will be a single arm phase II clinical trial of 8 weeks of daily, oral neo-adjuvant pazopanib prior to nephrectomy in 39 evaluable patients with histologically confirmed localized renal cell carcinoma (RCC).
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 |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pazopanib | Drug | Pazopanib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Single Arm Neoadjuvant Pazopanib
- description
- Pazopanib 800 mg PO once daily for 8 weeks
- interventionNames
- Drug: Pazopanib
Primary outcomes (1)
- measure
- Response Rate
- timeFrame
- 8 weeks after neoadjuvant treatment
- description
- Determine the objective response rate (CR+PR) using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 at 8 weeks after neoadjuvant treatment with pazopanib in patients with locally advanced renal cell carcinoma. Evaluation of Target Lesions using RECIST 1.1 Criteria: Complete response (CR)-Disappearance of all target lesions. Any pathological lymph node (LN) target or no must have decreased in short axis to \<10mm. Partial response (PR)-At least a 30% decrease in the sum of the longest diameter (LD) of the target lesions taking as reference the baseline sum LD.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years with radiographic evidence of nonmetastatic renal cell carcinoma * Histological verification of clear cell renal cell carcinoma (-Clinical stage 2 (7 cm) or greater with localized disease * No evidence of extranodal metastatic disease * Appropriate candidate for surgery * The Eastern Cooperative Oncology Group (ECOG) Performance status of 0-1 * Adequate organ function * Serum calcium, magnesium, potassium within normal limits, or if outside of normal limits, must be deemed clinically insignificant by the Investigator. * No known coagulopathy * Ability to read and follow instructions * Women of childbearing potential must have a negative serum pregnancy test performed within 14 days prior to the start of pazopanib treatment and both men and women must be willing to use adequate contraception. * Able to provide written, informed consent * Blood and urine samples must be provided from all subjects for biomarker analysis before and during treatment with pazopanib Exclusion Criteria * Known or suspected allergy to pazopanib * Inability to swallow or retain oral medication * Prior malignancy Exception: Subjects who have had another malignancy and have been disease-free for three years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible. * Unable or unwilling to discontinue use of prohibited medications at least 7 days prior to the first dose of study drug and for the duration of the study. * Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including * History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. * History of any one or more cardiovascular conditions within the past 6 months * Hypertension \[defined as systolic blood pressure (SBP) of ≥140 mmHg OR diastolic blood pressure (DBP) of ≥ 90 mmHg in spite of optimal medical management. * Evidence of active bleeding or bleeding diathesis. * Any serious and/or unstable pre-existing medical (especially hepatic disease), psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures. * Prior major surgery or trauma within 28 days prior to first dose of pazopanib and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major). * Pregnant or breastfeeding; breastfeeding may not resume for 14 days after the last dose of pazopanib * Prior treatment with any of the following anti-cancer therapies for treatment of their RCC: * radiation therapy, surgery or tumor embolization * chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy * Baseline Corrected QT Interval (QTc) \>480 msec or other clinically significant baseline ECG abnormality
References
Publications (0)
Data not yet available
No reference posted for this study.