Trial Outcomes & Findings for Bortezomib in Treating Patients With Metastatic Kidney Cancer (NCT NCT00276614)

Last Updated: 2020-09-01

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

2 months

Results posted on

2020-09-01

Recruitment period from April 2006 through May 2009 at outpatient oncology clinic.

Participant milestones
Measure	Bortezomib Bortezomib 1.3 mg/m2 given on days 1, 4, 8, 11 of a 21 day cycle.
Overall Study STARTED	4
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	3

Reasons for withdrawal
Measure	Bortezomib Bortezomib 1.3 mg/m2 given on days 1, 4, 8, 11 of a 21 day cycle.
Overall Study Progression of disease under study	3

Bortezomib in Treating Patients With Metastatic Kidney Cancer

Baseline characteristics by cohort
Measure	Bortezomib n=4 Participants Bortezomib 1.3 mg/m2 given on days 1, 4, 8, 11 of a 21 day cycle.
Age, Continuous	42 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

Timeframe: 2 months

Population: 2 subjects were excluded from analysis as they completed less than 2 cycles of study therapy.

Outcome measures
Measure	Bortezomib n=2 Participants Bortezomib 1.3 mg/m2 given on days 1, 4, 8, 11 of a 21 day cycle.
Objective Response Rate as Measured by RECIST Criteria After Every 2 Courses of Treatment for up to 6 Courses	2 participants

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Bortezomib n=4 participants at risk Bortezomib 1.3 mg/m2 given on days 1, 4, 8, 11 of a 21 day cycle.
Blood and lymphatic system disorders Thrombocytopenia	25.0% 1/4 • Number of events 1 • Beginning of treatment through 30 days post last treatment.
Gastrointestinal disorders Nausea	25.0% 1/4 • Number of events 1 • Beginning of treatment through 30 days post last treatment.
Gastrointestinal disorders Vomiting	25.0% 1/4 • Number of events 1 • Beginning of treatment through 30 days post last treatment.

David Geffen School of Medicine at UCLA

Phone: 310-794-3565