Trial Outcomes & Findings for Zoledronate With Atorvastatin in Renal Cell Carcinoma (NCT NCT00490698)

Results Overview

Time to skeletal events, defined as a metastatic site requiring radiotherapy or any surgical intervention (eg, embolization, radiofrequency ablation, intrathecal catheter placement) or complications from skeletal metastatic lesions (eg, pathologic fracture, spinal cord compression). Time to skeletal events monitored every 8 weeks for at least 1 year.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

Up to 1 year

Results posted on

2013-03-18

Participant Flow

Recruitment Period: October 1, 2006 to January 31, 2008. All recruitment done at UT MD Anderson Cancer Center.

Participant milestones

Participant milestones
Measure	Zoledronate + Atorvastatin Zoledronate 4 mg intravenous (IV) once every 4 Weeks + Atorvastatin 20 mg orally (PO) daily
Overall Study STARTED	11
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Zoledronate + Atorvastatin Zoledronate 4 mg intravenous (IV) once every 4 Weeks + Atorvastatin 20 mg orally (PO) daily
Overall Study Withdrawal by Subject	1
Overall Study Disease Progression	7
Overall Study Physician Decision	2

Baseline Characteristics

Zoledronate With Atorvastatin in Renal Cell Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Zoledronate + Atorvastatin n=11 Participants Zoledronate 4 mg intravenous (IV) once every 4 Weeks + Atorvastatin 20 mg orally (PO) daily
Age Continuous	56.6 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 1 year

Population: Four participants did not experience skeletal events.

Time to skeletal events, defined as a metastatic site requiring radiotherapy or any surgical intervention (eg, embolization, radiofrequency ablation, intrathecal catheter placement) or complications from skeletal metastatic lesions (eg, pathologic fracture, spinal cord compression). Time to skeletal events monitored every 8 weeks for at least 1 year.

Outcome measures

Outcome measures
Measure	Zoledronate + Atorvastatin n=7 Participants Zoledronate 4 mg intravenous (IV) once every 4 Weeks + Atorvastatin 20 mg orally (PO) daily
Median Time to First Skeletal-related Event	9 months Interval 4.1 to 18.1

Adverse Events

Zoledronate + Atorvastatin

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Zoledronate + Atorvastatin n=11 participants at risk Zoledronate 4 mg intravenous (IV) once every 4 Weeks + Atorvastatin 20 mg orally (PO) daily
Blood and lymphatic system disorders Transient ischemic attack	9.1% 1/11 • 4 years and 3 months "Definitely" and "Probably" related World Health Organization (WHO)classification grade 1 and 2 adverse events were reported.
Musculoskeletal and connective tissue disorders Bone Pain	9.1% 1/11 • 4 years and 3 months "Definitely" and "Probably" related World Health Organization (WHO)classification grade 1 and 2 adverse events were reported.

Other adverse events

Other adverse events
Measure	Zoledronate + Atorvastatin n=11 participants at risk Zoledronate 4 mg intravenous (IV) once every 4 Weeks + Atorvastatin 20 mg orally (PO) daily
Skin and subcutaneous tissue disorders Desquamatory rash	9.1% 1/11 • 4 years and 3 months "Definitely" and "Probably" related World Health Organization (WHO)classification grade 1 and 2 adverse events were reported.
Infections and infestations Fever	9.1% 1/11 • 4 years and 3 months "Definitely" and "Probably" related World Health Organization (WHO)classification grade 1 and 2 adverse events were reported.
General disorders Fatigue	100.0% 11/11 • 4 years and 3 months "Definitely" and "Probably" related World Health Organization (WHO)classification grade 1 and 2 adverse events were reported.
Blood and lymphatic system disorders Lymphopenia	9.1% 1/11 • 4 years and 3 months "Definitely" and "Probably" related World Health Organization (WHO)classification grade 1 and 2 adverse events were reported.

Additional Information

Shi-Ming Tu, MD / Professor

The University of Texas (UT) MD Anderson Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place