Trial Outcomes & Findings for Fulvestrant and Anastrozole as Consolidation Therapy in Postmenopausal Women With Advanced Non-small Cell Lung Cancer (NCT NCT00932152)

NCT ID: NCT00932152

Last Updated: 2017-10-19

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 3 participants
• Primary outcome timeframe: 1.5 years
• Results posted on: 2017-10-19

Participant Flow

No participants were randomized to the "Best supportive care only" and "Best supportive care with Bevacizumab" Arms due to low recruitment.

Participant milestones

Measure	Fulvestrant and Anastrozole Only	Fulvestrant, Anastrozole and Bevacizumab
Overall Study STARTED	1	2
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fulvestrant and Anastrozole as Consolidation Therapy in Postmenopausal Women With Advanced Non-small Cell Lung Cancer

Baseline characteristics by cohort

Measure	Fulvestrant and Anastrozole Only n=1 Participants	Fulvestrant, Anastrozole and Bevacizumab n=2 Participants	Total n=3 Participants Total of all reporting groups
Age, Continuous	67 years n=5 Participants	67.5 years n=7 Participants	67 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1.5 years

Population: Analysis was not completed because the trial was stopped prematurely due to slow accrual.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1.5 years

Population: No data displayed because Outcome Measure has zero total participants analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1.5 years

Population: No data displayed because Outcome Measure has zero total participants analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1.5 years

Population: No data displayed because Outcome Measure has zero total participants analyzed.

Outcome measures

Outcome data not reported

Adverse Events

All Participants (Overall Study)

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	All Participants (Overall Study) n=3 participants at risk
Metabolism and nutrition disorders Calcium, serum-high (hypercalcemia)	33.3% 1/3 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Vomiting	33.3% 1/3 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Obstruction, GI, Small bowel NOS	33.3% 1/3 Adverse events were not collected/monitored "per Arm/Group"
Nervous system disorders Neurology - Other	33.3% 1/3 Adverse events were not collected/monitored "per Arm/Group"

Other adverse events

Measure	All Participants (Overall Study) n=3 participants at risk
Investigations Leukocytes (total WBC)	33.3% 1/3 Adverse events were not collected/monitored "per Arm/Group"
Investigations Lymphopenia	33.3% 1/3 Adverse events were not collected/monitored "per Arm/Group"
Investigations Neutrophils/granulocytes (ANC/AGC)	33.3% 1/3 Adverse events were not collected/monitored "per Arm/Group"
Vascular disorders Hypertension	66.7% 2/3 Adverse events were not collected/monitored "per Arm/Group"
General disorders Fatigue (asthenia, lethargy, malaise)	66.7% 2/3 Adverse events were not collected/monitored "per Arm/Group"
General disorders Rigors/chills	33.3% 1/3 Adverse events were not collected/monitored "per Arm/Group"
Skin and subcutaneous tissue disorders Dermatology/Skin - Other	33.3% 1/3 Adverse events were not collected/monitored "per Arm/Group"
Skin and subcutaneous tissue disorders Dry skin	33.3% 1/3 Adverse events were not collected/monitored "per Arm/Group"
Skin and subcutaneous tissue disorders Hair loss/alopecia (scalp or body)	33.3% 1/3 Adverse events were not collected/monitored "per Arm/Group"
Skin and subcutaneous tissue disorders Rash: acne/acneiform	33.3% 1/3 Adverse events were not collected/monitored "per Arm/Group"
Vascular disorders Hot flashes/flushes	66.7% 2/3 Adverse events were not collected/monitored "per Arm/Group"
Endocrine disorders Thyroid function, low (hypothyroidism)	33.3% 1/3 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Constipation	33.3% 1/3 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Mucositis/stomatitis (functional/symptomatic), Oral cavity	33.3% 1/3 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Nausea	33.3% 1/3 Adverse events were not collected/monitored "per Arm/Group"
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils, Conjunctiva	33.3% 1/3 Adverse events were not collected/monitored "per Arm/Group"
Investigations ALT, SGPT (serum glutamic pyruvic transaminase)	33.3% 1/3 Adverse events were not collected/monitored "per Arm/Group"
Investigations AST, SGOT(serum glutamic oxaloacetic transaminase)	33.3% 1/3 Adverse events were not collected/monitored "per Arm/Group"
Metabolism and nutrition disorders Bicarbonate, serum-low	33.3% 1/3 Adverse events were not collected/monitored "per Arm/Group"
Investigations Bilirubin (hyperbilirubinemia)	33.3% 1/3 Adverse events were not collected/monitored "per Arm/Group"
Renal and urinary disorders Glomerular filtration rate	33.3% 1/3 Adverse events were not collected/monitored "per Arm/Group"
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	66.7% 2/3 Adverse events were not collected/monitored "per Arm/Group"
Metabolism and nutrition disorders Glucose, serum-low (hypoglycemia)	33.3% 1/3 Adverse events were not collected/monitored "per Arm/Group"
Psychiatric disorders Mood alteration, Depression	33.3% 1/3 Adverse events were not collected/monitored "per Arm/Group"
Nervous system disorders Neurology - Other	33.3% 1/3 Adverse events were not collected/monitored "per Arm/Group"
Nervous system disorders Neuropathy: sensory	33.3% 1/3 Adverse events were not collected/monitored "per Arm/Group"
Eye disorders Watery eye (epiphora, tearing)	33.3% 1/3 Adverse events were not collected/monitored "per Arm/Group"
Gastrointestinal disorders Pain, Abdomen NOS	33.3% 1/3 Adverse events were not collected/monitored "per Arm/Group"
Musculoskeletal and connective tissue disorders Pain, Back	33.3% 1/3 Adverse events were not collected/monitored "per Arm/Group"
Musculoskeletal and connective tissue disorders Pain, Extremity-limb	33.3% 1/3 Adverse events were not collected/monitored "per Arm/Group"
Nervous system disorders Pain, Head/headache	33.3% 1/3 Adverse events were not collected/monitored "per Arm/Group"
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 Adverse events were not collected/monitored "per Arm/Group"
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	33.3% 1/3 Adverse events were not collected/monitored "per Arm/Group"
Reproductive system and breast disorders Vaginal dryness	33.3% 1/3 Adverse events were not collected/monitored "per Arm/Group"

Additional Information

Ahmad Tarhini, MD

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