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NCT01392183

Pazopanib Versus Temsirolimus in Poor-Risk Clear-Cell Renal Cell Carcinoma (RCC)

Completed Phase 2 Results posted Last updated 20 September 2021
What this trial tests

Phase 2 trial testing Pazopanib in Kidney Cancer in 69 participants. Completed in 8 September 2019.

Timeline
24 October 2012
Primary endpoint
8 September 2019
8 September 2019

Quick facts

Lead sponsorM.D. Anderson Cancer Center
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposetreatment
Enrollment69
Start date24 October 2012
Primary completion8 September 2019
Estimated completion8 September 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Kidney Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Progression Free Survival (PFS) Primary · Measured form start of treatment up to 3 years

PFS is measured from the initiation of treatment to the time of first disease progression or death due to any reason during the first drug administration in each arm. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% or more increase in the sum of the longest diameters of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions. The PFS median of first drug pazopanib (treatment group) was compared to the PFS median of first drug temsirolimus (control group) in an adjusted Hazard ratio. The hazard r

GroupValue95% CI
Temsirolimus (Control Group)2.71.2 – 24.6
Pazopanib (Treatment Group)5.20.4 – 34.5
Overall Survival (OS) Secondary · From the start of treatment up to 6 years or death, whichever came first

Overall survival is calculated from day of therapy initiation of the first administrated drug to the date of death. Kaplan-Meier estimator used to estimate the OS for each group of participants. The Overall Survival median of first drug pazopanib (treatment group) was compared to the Overall Survival median of first drug temsirolimus (control group) in an adjusted Hazard ratio. The hazard ratio compares events from a treatment group to a control group. If the hazard ratio is greater than 1the treatment group performed better. If the hazard ratio is less than 1 the control group performed bette

GroupValue95% CI
Temsirolimus (Control Group)7.12.4 – 68.8
Pazopanib (Treatment Group)11.91.3 – 63.4

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Temsirolimus (Control Group)
Serious: 15/50 (30%)
Deaths: 32/50
Pazopanib (Treatment Group)
Serious: 10/55 (18%)
Deaths: 31/55

Serious adverse events (23 terms)

ReactionSystemTemsirolimus (Control Group)Pazopanib (Treatment Group)
DyspneaRespiratory, thoracic and mediastinal disorders
EdemaBlood and lymphatic system disorders
Acute Kidney InjuryRenal and urinary disorders
NauseaGastrointestinal disorders
PneumoniaRespiratory, thoracic and mediastinal disorders
Non-cardiac chest painRespiratory, thoracic and mediastinal disorders
Chest pain-cardicCardiac disorders
Back PainNervous system disorders
PainNervous system disorders
HypophosphatemiaMetabolism and nutrition disorders
Infusion Related ReactionImmune system disorders
Urinary Tract InfectionRenal and urinary disorders
FatigueGeneral disorders
PneumonitisRespiratory, thoracic and mediastinal disorders
Pleural EffusionRespiratory, thoracic and mediastinal disorders
EnterocolitisGastrointestinal disorders
Platelet Count DecreasedBlood and lymphatic system disorders
Creatinine IncreasedRenal and urinary disorders
HyperglycemiaEndocrine disorders
VomitingGastrointestinal disorders
Mucositis oralSkin and subcutaneous tissue disorders
Skin breakdownSkin and subcutaneous tissue disorders
Thrombotic thrombocytopenic purpuraBlood and lymphatic system disorders
Other adverse events (56 terms — click to expand)

ReactionSystemTemsirolimus (Control Group)Pazopanib (Treatment Group)
HyperglycemiaMetabolism and nutrition disorders
DiarrheaGastrointestinal disorders
HypertriglyeridemiaMetabolism and nutrition disorders
NauseaGastrointestinal disorders
AnemiaBlood and lymphatic system disorders
Mucositis oralGastrointestinal disorders
HypertensionVascular disorders
HypothyroidismEndocrine disorders
FatigueGeneral disorders
VomitingGastrointestinal disorders
RashSkin and subcutaneous tissue disorders
Creatinine IncreasedRenal and urinary disorders
Skin hypopigmentationSkin and subcutaneous tissue disorders
ALT IncreasedHepatobiliary disorders
AST increasedHepatobiliary disorders
ProteinuriaRenal and urinary disorders
DysgeusiaGastrointestinal disorders
AnorexiaGastrointestinal disorders
EdemaGeneral disorders
Alk Phos IncreasedHepatobiliary disorders
Platelet count decreasedBlood and lymphatic system disorders
Weight lossGeneral disorders
ConstipationGastrointestinal disorders
PainGeneral disorders
HypernatremiaMetabolism and nutrition disorders
HypoalbuminemiaInvestigations
White blood cell decreasedBlood and lymphatic system disorders
HypoalbuminemiaMetabolism and nutrition disorders
DyspneaRespiratory, thoracic and mediastinal disorders
HyponatremiaMetabolism and nutrition disorders
HyperkalemiaMetabolism and nutrition disorders
Abdominal PainGastrointestinal disorders
HypokalemiaMetabolism and nutrition disorders
lymphocyte Count DecreasedBlood and lymphatic system disorders
HypophosphatemiaMetabolism and nutrition disorders
HypomagnesemiaMetabolism and nutrition disorders
Palmar-plantar erythrodeysesthesiaSkin and subcutaneous tissue disorders
Bilirubin increasedHepatobiliary disorders
AlopeciaSkin and subcutaneous tissue disorders
CoughRespiratory, thoracic and mediastinal disorders

Most-reported serious reactions: Dyspnea, Edema, Acute Kidney Injury, Nausea, Pneumonia, Non-cardiac chest pain, Chest pain-cardic, Back Pain.

Data from ClinicalTrials.gov NCT01392183 adverse events section.

Sponsor's own description

The goal of this clinical research study is to compare pazopanib to temsirolimus in the treatment of advanced clear-cell renal cell carcinoma. The safety of each drug will also be studied. Pazopanib is designed to block the growth of blood vessels that supply nutrients needed for tumor growth. This may prevent or slow the growth of cancer cells. Temsirolimus is designed to block the growth of cancer cells, which may cause cancer cells to die. This is an investigational study. Pazopanib and temsirolimus are both FDA approved and commercially available for the treatment of kidney cancer. It is investigational to compare the 2 drugs. Up to 90 patients will be enrolled in this study. All will be enrolled at MD Anderson.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The prospects of pazopanib in advanced renal cell carcinoma.
    Gupta S, Spiess PE. · · 2013 · cited 27× · PMID 24082917 · DOI 10.1177/1756287213495099
  2. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis.
    Aldin A, Besiroglu B, Adams A, Monsef I, et al · · 2023 · cited 20× · PMID 37146227 · DOI 10.1002/14651858.cd013798.pub2
  3. Tyrosine kinase inhibitors in the treatment of advanced renal cell carcinoma: focus on pazopanib.
    Vasudev NS, Larkin JM. · · 2011 · cited 10× · PMID 22084622 · DOI 10.4137/cmo.s7263
  4. Pharmacotherapy options in advanced renal cell carcinoma: what role for pazopanib?
    Harrison MR. · · 2011 · cited 4× · PMID 22174596 · DOI 10.4137/cmo.s6087

Verify or expand the search:

Other trials of Pazopanib

Trials testing the same drug.

Other recruiting trials for Kidney Cancer

Currently open trials in the same condition.

Other M.D. Anderson Cancer Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01392183.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing