Trial Outcomes & Findings for Trial of RAD001 in Triple Negative Metastatic Breast Cancer (NCT NCT00827567)

Results Overview

Progression is defined by RESIST criteria as any new lesion or the sum of target lesions increasing by 20% over baseline

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

Each patient assessed at 8 weeks from start of study drug

Results posted on

2014-01-13

Participant Flow

Recruitment period 4/13/2009 through 2/25/2011. Protocol dated 3/6/2009 \& consent dated 4/8/2009 for the 4/13/2009 approval.Patients were seen at Penn State Cancer Institute Outpatient Unit.

Two of the patients that were screen failures had cholesterol levels higher than inclusion criteria as this drug may increase cholesterol levels they were not eligible.

Participant milestones

Participant milestones
Measure	RAD 001 RAD001-10 mg by mouth once everyday
Overall Study STARTED	4
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	RAD 001 RAD001-10 mg by mouth once everyday
Overall Study Progression of Disease/Screen Failure	4

Baseline Characteristics

Trial of RAD001 in Triple Negative Metastatic Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RAD 001 n=4 Participants RAD001-10 mg by mouth once everyday
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	58.5 years STANDARD_DEVIATION 7.65 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: Each patient assessed at 8 weeks from start of study drug

Progression is defined by RESIST criteria as any new lesion or the sum of target lesions increasing by 20% over baseline

Outcome measures

Outcome data not reported

Adverse Events

RAD 001

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	RAD 001 n=4 participants at risk RAD001-10 mg by mouth once everyday
Blood and lymphatic system disorders Anemia	50.0% 2/4 • Number of events 3 • Weekly for 4 weeks, then monthly until disease progression
Blood and lymphatic system disorders Thrombocytopenia	25.0% 1/4 • Number of events 1 • Weekly for 4 weeks, then monthly until disease progression

Additional Information

Allan Lipton, MD

Penn State

Phone: 717-531-5960

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place