Trial Outcomes & Findings for Pazopanib Versus Temsirolimus in Poor-Risk Clear-Cell Renal Cell Carcinoma (RCC) (NCT NCT01392183)

Last Updated: 2021-09-20

Results Overview

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 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 better. If the hazard ratio is equal to 1, then the groups performed equally.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

69 participants

Primary outcome timeframe

Measured form start of treatment up to 3 years

Results posted on

2021-09-20

Participant Flow

Recruitment Period: October 2012 to September 2017

Participant milestones

Participant milestones
Measure	Temsirolimus (Control Group) Temsirolimus 25 mg intravenously weekly. Upon progression patient crosses over over to pazopanib 800 mg orally daily. Treatments stop for progression, toxicity, withdrawal, or death.	Pazopanib (Treatment Group) Pazopanib 800 mg orally daily. Upon progression patient crosses over to temsirolimus 25 mg intravenously weekly. Treatments stop for progression, toxicity, withdrawal, or death.
First Drug Administration STARTED	35	34
First Drug Administration Eligible to Cross Over to 2nd Drug	29	31
First Drug Administration COMPLETED	21	15
First Drug Administration NOT COMPLETED	14	19
Second Drug Administration STARTED	21	15
Second Drug Administration Treatment Ended: Progression	18	11
Second Drug Administration Treatment Ended: Adverse Events	1	2
Second Drug Administration Treatment Ended: Participant Withdrew	2	1
Second Drug Administration Treatment Ended: Death	0	1
Second Drug Administration COMPLETED	21	15
Second Drug Administration NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Temsirolimus (Control Group) Temsirolimus 25 mg intravenously weekly. Upon progression patient crosses over over to pazopanib 800 mg orally daily. Treatments stop for progression, toxicity, withdrawal, or death.	Pazopanib (Treatment Group) Pazopanib 800 mg orally daily. Upon progression patient crosses over to temsirolimus 25 mg intravenously weekly. Treatments stop for progression, toxicity, withdrawal, or death.
First Drug Administration Adverse Event	3	2
First Drug Administration Death	1	0
First Drug Administration Withdrawal by Subject	10	17

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Temsirolimus (Control Group) n=35 Participants Temsirolimus 25 mg intravenously weekly. Upon progression patient crosses over to pazopanib 800 mg orally daily. Treatments stop for progression, toxicity, withdrawal, or death.	Pazopanib (Treatment Group) n=34 Participants Pazopanib 800 mg orally daily. Upon progression patient crosses over to temsirolimus 25 mg intravenously weekly. Treatments stop for progression, toxicity, withdrawal, or death.	Total n=69 Participants Total of all reporting groups
Age, Continuous	61 years n=93 Participants	61 years n=4 Participants	61 years n=27 Participants
Sex: Female, Male Female	11 Participants n=93 Participants	6 Participants n=4 Participants	17 Participants n=27 Participants
Sex: Female, Male Male	24 Participants n=93 Participants	28 Participants n=4 Participants	52 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=93 Participants	3 Participants n=4 Participants	8 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=93 Participants	13 Participants n=4 Participants	24 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	19 Participants n=93 Participants	18 Participants n=4 Participants	37 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	4 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Race (NIH/OMB) White	27 Participants n=93 Participants	26 Participants n=4 Participants	53 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=93 Participants	3 Participants n=4 Participants	8 Participants n=27 Participants
Region of Enrollment United States	35 participants n=93 Participants	34 participants n=4 Participants	69 participants n=27 Participants
Karnofsky Performance Status (KPS) Score 100%	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Karnofsky Performance Status (KPS) Score 90%	12 Participants n=93 Participants	10 Participants n=4 Participants	22 Participants n=27 Participants
Karnofsky Performance Status (KPS) Score 80%	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Karnofsky Performance Status (KPS) Score 70%	20 Participants n=93 Participants	21 Participants n=4 Participants	41 Participants n=27 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Score 0	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Score 1	14 Participants n=93 Participants	12 Participants n=4 Participants	26 Participants n=27 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Score 2	20 Participants n=93 Participants	21 Participants n=4 Participants	41 Participants n=27 Participants
Poor -Risk With Disease Eligibility Score. 3 Factors	12 Participants n=93 Participants	12 Participants n=4 Participants	24 Participants n=27 Participants
Poor -Risk With Disease Eligibility Score. 4 Factors	18 Participants n=93 Participants	19 Participants n=4 Participants	37 Participants n=27 Participants
Poor -Risk With Disease Eligibility Score. 5 Factors	5 Participants n=93 Participants	3 Participants n=4 Participants	8 Participants n=27 Participants
International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Risk Score Favorable risk	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Risk Score Intermediate risk	11 Participants n=93 Participants	8 Participants n=4 Participants	19 Participants n=27 Participants
International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Risk Score Poor Risk	24 Participants n=93 Participants	26 Participants n=4 Participants	50 Participants n=27 Participants

PRIMARY outcome

Timeframe: Measured form start of treatment up to 3 years

Population: The ratio is comparing both arms to each other, therefore the data would be identical.

Outcome measures

Outcome measures
Measure	Temsirolimus (Control Group) n=35 Participants Temsirolimus 25 mg intravenously weekly. Upon progression patient crosses over to pazopanib 800 mg orally daily. Treatments stop for progression, toxicity, withdrawal, or death.	Pazopanib (Treatment Group) n=34 Participants Pazopanib 800 mg orally daily. Upon progression patient crosses over to temsirolimus 25 mg intravenously weekly. Treatments stop for progression, toxicity, withdrawal, or death
Progression Free Survival (PFS)	2.7 months Interval 1.2 to 24.6	5.2 months Interval 0.4 to 34.5

SECONDARY outcome

Timeframe: From the start of treatment up to 6 years or death, whichever came first

Population: The ratio is comparing both arms to each other, therefore the data would be identical.

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 better. If the hazard ratio is equal to 1, then the groups performed equally.

Outcome measures

Outcome measures
Measure	Temsirolimus (Control Group) n=35 Participants Temsirolimus 25 mg intravenously weekly. Upon progression patient crosses over to pazopanib 800 mg orally daily. Treatments stop for progression, toxicity, withdrawal, or death.	Pazopanib (Treatment Group) n=34 Participants Pazopanib 800 mg orally daily. Upon progression patient crosses over to temsirolimus 25 mg intravenously weekly. Treatments stop for progression, toxicity, withdrawal, or death
Overall Survival (OS)	7.1 months Interval 2.4 to 68.8	11.9 months Interval 1.3 to 63.4

Adverse Events

Temsirolimus (Control Group)

Serious events: 15 serious events

Other events: 35 other events

Deaths: 32 deaths

Pazopanib (Treatment Group)

Serious events: 10 serious events

Other events: 33 other events

Deaths: 31 deaths

Serious adverse events

Other adverse events

Additional Information

Amado J. .Zurita-Saavedra, MD/ Associate Professor, Genitourinary Medical Oncology

UT MD Anderson Cancer Center

Phone: 713- 563-6966

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Temsirolimus (Control Group) n=50 participants at risk Temsirolimus 25 mg intravenously weekly. Upon progression patient crosses over to pazopanib 800 mg orally daily. Treatments stop for progression, toxicity, withdrawal, or death.	Pazopanib (Treatment Group) n=55 participants at risk Pazopanib 800 mg orally daily. Upon progression patient crosses over to temsirolimus 25 mg intravenously weekly. Treatments stop for progression, toxicity, withdrawal, or death.
Renal and urinary disorders Acute Kidney Injury	2.0% 1/50 • Number of events 1 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.	3.6% 2/55 • Number of events 2 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.
Respiratory, thoracic and mediastinal disorders Non-cardiac chest pain	2.0% 1/50 • Number of events 1 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.	0.00% 0/55 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.
Cardiac disorders Chest pain-cardic	2.0% 1/50 • Number of events 1 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.	0.00% 0/55 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.
Gastrointestinal disorders Nausea	4.0% 2/50 • Number of events 2 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.	1.8% 1/55 • Number of events 1 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.
Respiratory, thoracic and mediastinal disorders Dyspnea	6.0% 3/50 • Number of events 3 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.	0.00% 0/55 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.
Nervous system disorders Back Pain	0.00% 0/50 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.	1.8% 1/55 • Number of events 1 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.
Nervous system disorders Pain	2.0% 1/50 • Number of events 1 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.	0.00% 0/55 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/50 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.	1.8% 1/55 • Number of events 1 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.
Immune system disorders Infusion Related Reaction	2.0% 1/50 • Number of events 1 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.	0.00% 0/55 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.
Renal and urinary disorders Urinary Tract Infection	0.00% 0/50 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.	1.8% 1/55 • Number of events 1 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.
General disorders Fatigue	2.0% 1/50 • Number of events 1 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.	0.00% 0/55 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.0% 1/50 • Number of events 1 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.	0.00% 0/55 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	2.0% 1/50 • Number of events 1 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.	0.00% 0/55 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.
Gastrointestinal disorders Enterocolitis	2.0% 1/50 • Number of events 1 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.	0.00% 0/55 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.
Blood and lymphatic system disorders Platelet Count Decreased	0.00% 0/50 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.	1.8% 1/55 • Number of events 1 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.
Renal and urinary disorders Creatinine Increased	2.0% 1/50 • Number of events 1 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.	1.8% 1/55 • Number of events 1 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.
Endocrine disorders Hyperglycemia	2.0% 1/50 • Number of events 1 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.	0.00% 0/55 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.
Blood and lymphatic system disorders Edema	6.0% 3/50 • Number of events 3 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.	0.00% 0/55 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.
Gastrointestinal disorders Vomiting	2.0% 1/50 • Number of events 1 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.	0.00% 0/55 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.
Skin and subcutaneous tissue disorders Mucositis oral	0.00% 0/50 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.	1.8% 1/55 • Number of events 1 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.
Respiratory, thoracic and mediastinal disorders Pneumonia	4.0% 2/50 • Number of events 2 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.	0.00% 0/55 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.
Skin and subcutaneous tissue disorders Skin breakdown	0.00% 0/50 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.	1.8% 1/55 • Number of events 1 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.
Blood and lymphatic system disorders Thrombotic thrombocytopenic purpura	0.00% 0/50 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.	1.8% 1/55 • Number of events 1 • Baseline to study completion or date of death from any cause, whichever came first, assessed up to 5 years. The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.