Phase 3 N=615 Randomized Triple-blind Treatment

A Clinical Trial Comparing Efficacy And Safety Of Sunitinib Versus Placebo For TheTreatment Of Patients At High Risk Of Recurrent Renal Cell Cancer

Kidney Neoplasms

Bottom Line

View on ClinicalTrials.gov: NCT00375674 ↗

Enrolled (actual)

615

Serious AEs

19.5%

Results posted

Aug 2017

Primary outcome: Primary: Disease-free Survival (DFS)- Assessed by Blinded Independent Central Review — 6.8; 5.6 Number of years — p=0.030

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Sunitinib malate (Drug); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Apr 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Disease-free Survival (DFS)- Assessed by Blinded Independent Central Review	6.8; 5.6	0.030 sig
PRIMARY DFS- Assessed by the Investigator [Stratified by University of California Los Angeles Integrated Staging System (UISS) High Risk Group-Intent to Treat Population]	6.5; 4.5	0.077
SECONDARY Overall Survival (OS)- (Stratified by UISS High Risk Group-Intent to Treat Population)	NA; NA	0.661
SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity	305; 270; 67; 52; 189; 61	—
SECONDARY Summary of Duration of Treatment-Emergent Adverse Events of Special Interest by MedDRA Preferred Terms (All Causalities, All Cycles)	35.1; 305.6; 23.2; 110.8; 46.9; 58.0	—
SECONDARY Patient-Reported Outcomes (PROs)- European Organization for Research and Treatment of Cancer (EORTC) QLQ C30: Observed Means in Global Health Status / Quality of Life Scale Scores	74.83; 75.61; 69.71; 75.49; 69.67; 74.09	—
SECONDARY PROs- EORTC QLQ C30: Functional Scale Scores Between Treatment Comparison	83.54; 87.53; 78.94; 85.46; 80.92; 82.97	—
SECONDARY PROs- EORTC QLQ-C30: Symptom Scale Scores Between Treatment Comparison	29.94; 21.74; 7.35; 3.46; 21.81; 16.63	—
SECONDARY PROs- EuroQoL EQ-5D Observed Means - Intent to Treat Population	0.84; 0.83; 0.83; 0.84; 0.80; 0.82	—
SECONDARY PROs- EuroQol European Quality of Life Questionnaire Variable Analogue Scale (EQ-VAS) Observed Means	77.31; 75.67; 74.39; 76.99; 74.20; 76.85	—
SECONDARY Number of Participants With Tolerability Symptoms	13; 0; 6; 0; 4; 0	—

Summary

To compare the disease free survival time and safety of sunitinib with placebo in adjuvant treatment patients at high risk of recurrent kidney cancer after surgery.

Eligibility Criteria

Inclusion Criteria

High risk renal cancer per modified UISS criteria
Eastern Cooperative Oncology Group (ECOG) 0-2
predominant clear cell histology
No prior anti-cancer treatment
Kidney tumor has been removed
No evidence of macroscopic disease following surgery

Exclusion Criteria

Histologically undifferentiated carcinomas or collecting duct carcinoma, lymphoma, sarcoma or subjects with metastatic renal sites.
Diagnosis of any second malignancy within the last 5 years, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma of the cervix uteri that has been adequately treated with no evidence of recurrent disease for 12 months
known HIV or Hepatitis
any severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00375674). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.