Trial Outcomes & Findings for Phase II Trial of RAD001 (Everolimus) in Previously Treated Small Cell Lung Cancer (NCT NCT00374140)

NCT ID: NCT00374140

Last Updated: 2017-10-19

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 40 participants
• Primary outcome timeframe: Two cycles of treatment with RAD001 (~6 weeks)
• Results posted on: 2017-10-19

Participant Flow

Participant milestones

Measure	RAD001 (Everolimus) RAD001 (everolimus): 10 mg by mouth daily without interruption for 3-week cycles until disease progression or intolerable toxicities
Overall Study STARTED	40
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	RAD001 (Everolimus) RAD001 (everolimus): 10 mg by mouth daily without interruption for 3-week cycles until disease progression or intolerable toxicities
Overall Study Lost to Follow-up	1
Overall Study Protocol Violation	1

Baseline Characteristics

Phase II Trial of RAD001 (Everolimus) in Previously Treated Small Cell Lung Cancer

Baseline characteristics by cohort

Measure	RAD001 (Everolimus) n=40 Participants RAD001 (everolimus): 10 mg by mouth daily without interruption for 3-week cycles until disease progression or intolerable toxicities
Age, Customized	64 years n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: Two cycles of treatment with RAD001 (~6 weeks)

Outcome measures

Measure	RAD001 (Everolimus) n=35 Participants RAD001 (everolimus): 10 mg by mouth daily without interruption for 3-week cycles until disease progression or intolerable toxicities
Determine the Proportion of Previously Treated Small Cell Lung Cancer (SCLC) Patients Whose Disease Has Not Progressed Following 6-weeks (2 Cycles) of Treatment With RAD001.	26 percentage of participants Interval 11.0 to 40.0

SECONDARY outcome

Timeframe: From entry in trial to up to 60 months

Outcome measures

Measure	RAD001 (Everolimus) n=40 Participants RAD001 (everolimus): 10 mg by mouth daily without interruption for 3-week cycles until disease progression or intolerable toxicities
Overall Survival	6.7 months Interval 4.0 to 8.6

SECONDARY outcome

Timeframe: From entry into trial to up to 60 months

Outcome measures

Measure	RAD001 (Everolimus) n=35 Participants RAD001 (everolimus): 10 mg by mouth daily without interruption for 3-week cycles until disease progression or intolerable toxicities
Progression-free Survival	1.3 months Interval 1.3 to 1.4

SECONDARY outcome

Timeframe: From beginning of treatment up to 60 months

Population: Evaluable for response included patient had completed at least one cycle of therapy with everolimus.

Number of patients for which response to treatment was observed / total number of patients.

Outcome measures

Measure	RAD001 (Everolimus) n=35 Participants RAD001 (everolimus): 10 mg by mouth daily without interruption for 3-week cycles until disease progression or intolerable toxicities
Objective Response Rate	3 percentage of participants Interval 0.0 to 8.0

Adverse Events

RAD001 (Everolimus)

Serious events: 18 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Measure	RAD001 (Everolimus) n=40 participants at risk RAD001 (everolimus): 10 mg by mouth daily without interruption for 3-week cycles until disease progression or intolerable toxicities
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Death due to progressive disease	2.5% 1/40
Metabolism and nutrition disorders Metabolism and nutrition disorders	10.0% 4/40
Psychiatric disorders Confusion	5.0% 2/40
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	12.5% 5/40
Gastrointestinal disorders Gastrointestinal Fistula	2.5% 1/40
Blood and lymphatic system disorders Anemia	2.5% 1/40
Infections and infestations Infection with normal ANC or grade 1 or 2 Neutrophils	7.5% 3/40
Nervous system disorders Somnolence	2.5% 1/40

Other adverse events

Measure	RAD001 (Everolimus) n=40 participants at risk RAD001 (everolimus): 10 mg by mouth daily without interruption for 3-week cycles until disease progression or intolerable toxicities
General disorders Constitutional	30.0% 12/40
Gastrointestinal disorders Gastrointestinal	50.0% 20/40
Hepatobiliary disorders Increased transaminases	7.5% 3/40
Infections and infestations Infection (without neutropenia)	12.5% 5/40
Metabolism and nutrition disorders Metabolic	17.5% 7/40
Nervous system disorders Lethargy, confusion	5.0% 2/40
Respiratory, thoracic and mediastinal disorders Dyspnea, pneumonitis	7.5% 3/40
Renal and urinary disorders Increased creatinine (dehydration)	2.5% 1/40
Skin and subcutaneous tissue disorders Rash	15.0% 6/40
Blood and lymphatic system disorders Anemia	22.5% 9/40
Investigations Neutropenia	32.5% 13/40
Investigations Thrombocytopenia	15.0% 6/40

Additional Information

Ahmad Tarhini, MD, PhD

University of Pittsburgh

Phone: (412) 648-6578

Email: tarhiniaa@upmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place