Trial Outcomes & Findings for Exemestane in Post-Menopausal Women With NSCLC (NCT NCT02666105)

Last Updated: 2023-05-31

Results Overview

Initial disease response will be assessed from 6 weeks to 1 year after the start of exemestane using the Response Criteria in Solid Tumors (RECIST). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

6 weeks

Results posted on

2023-05-31

Participant Flow

Participant milestones

Participant milestones
Measure	Exemestane Therapy Exemestane: One 25 mg tablet once daily for a minimum of 6 weeks
Overall Study STARTED	6
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Exemestane Therapy Exemestane: One 25 mg tablet once daily for a minimum of 6 weeks
Overall Study Death	1

Baseline Characteristics

Exemestane in Post-Menopausal Women With NSCLC

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Exemestane Therapy n=6 Participants Exemestane: One 25 mg tablet once daily for a minimum of 6 weeks
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 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	6 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
Region of Enrollment United States	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Outcome measures

Outcome measures
Measure	Exemestane Therapy n=6 Participants Exemestane: One 25 mg tablet once daily for a minimum of 6 weeks	Exemestane Therapy - 3 Weeks Quality of life assessment at three weeks of treatment.	Exemestane Therapy - 6 Weeks Quality of life assessment at six weeks of treatment.	Exemestane Therapy - 9 Weeks Quality of life assessment at nine weeks of treatment.	Exemestane Therapy - 12 Weeks Quality of life assessment at twelve weeks of treatment.	Exemestane Therapy - 15 Weeks Quality of life assessment at fifteen weeks of treatment.	Exemestane Therapy - 18 Weeks Quality of life assessment at end of treatment, eighteen weeks of treatment.	Exemestane Therapy - 1 Month Post-Treatment Quality of life assessment one month post-treatment.
Disease Response (RECIST)	NA days Insufficient number of participants with events.	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Post Treatment Day 30

Toxicity will be assessed from the 1st dose to Post Treatment Day 30, up to 22 weeks. Toxicity severity will be graded using the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.

Outcome measures

Outcome measures
Measure	Exemestane Therapy n=5 Participants Exemestane: One 25 mg tablet once daily for a minimum of 6 weeks	Exemestane Therapy - 3 Weeks Quality of life assessment at three weeks of treatment.	Exemestane Therapy - 6 Weeks Quality of life assessment at six weeks of treatment.	Exemestane Therapy - 9 Weeks Quality of life assessment at nine weeks of treatment.	Exemestane Therapy - 12 Weeks Quality of life assessment at twelve weeks of treatment.	Exemestane Therapy - 15 Weeks Quality of life assessment at fifteen weeks of treatment.	Exemestane Therapy - 18 Weeks Quality of life assessment at end of treatment, eighteen weeks of treatment.	Exemestane Therapy - 1 Month Post-Treatment Quality of life assessment one month post-treatment.
Toxicity Assessment	14 Adverse Events	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 1 year after enrollment

progression-free survival will be assessed until 1 year after study enrollment based on the definitions found in RECIST 1.1

Outcome measures

Outcome measures
Measure	Exemestane Therapy n=6 Participants Exemestane: One 25 mg tablet once daily for a minimum of 6 weeks	Exemestane Therapy - 3 Weeks Quality of life assessment at three weeks of treatment.	Exemestane Therapy - 6 Weeks Quality of life assessment at six weeks of treatment.	Exemestane Therapy - 9 Weeks Quality of life assessment at nine weeks of treatment.	Exemestane Therapy - 12 Weeks Quality of life assessment at twelve weeks of treatment.	Exemestane Therapy - 15 Weeks Quality of life assessment at fifteen weeks of treatment.	Exemestane Therapy - 18 Weeks Quality of life assessment at end of treatment, eighteen weeks of treatment.	Exemestane Therapy - 1 Month Post-Treatment Quality of life assessment one month post-treatment.
Progression-free Survival	17 Percentage of participants Interval 1.0 to 52.0	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Treatment, End of Treatment, and 1 Month Post-Treatment

Quality of life will be assessed by use of Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29) at baseline, every 3 weeks from the 1st dose to Post Treatment Day 30, up to 22 weeks. Patient's report on a number of subjects on a 0-10 scale. The scores range from 28 to 150. 50 is the average score, 28 is the best health and 150 is the worst health.

Outcome measures

Outcome measures
Measure	Exemestane Therapy n=4 Participants Exemestane: One 25 mg tablet once daily for a minimum of 6 weeks	Exemestane Therapy - 3 Weeks n=4 Participants Quality of life assessment at three weeks of treatment.	Exemestane Therapy - 6 Weeks n=3 Participants Quality of life assessment at six weeks of treatment.	Exemestane Therapy - 9 Weeks n=3 Participants Quality of life assessment at nine weeks of treatment.	Exemestane Therapy - 12 Weeks n=2 Participants Quality of life assessment at twelve weeks of treatment.	Exemestane Therapy - 15 Weeks n=2 Participants Quality of life assessment at fifteen weeks of treatment.	Exemestane Therapy - 18 Weeks n=2 Participants Quality of life assessment at end of treatment, eighteen weeks of treatment.	Exemestane Therapy - 1 Month Post-Treatment n=2 Participants Quality of life assessment one month post-treatment.
Quality of Life Assessment	44 Score on a scale Interval 44.0 to 45.0	52 Score on a scale Interval 41.0 to 88.0	45 Score on a scale Interval 41.0 to 57.0	51 Score on a scale Interval 48.0 to 115.0	46 Score on a scale Interval 40.0 to 51.0	57 Score on a scale Interval 46.0 to 67.0	55 Score on a scale Interval 41.0 to 69.0	57 Score on a scale Interval 46.0 to 68.0

Adverse Events

Exemestane Therapy

Serious events: 6 serious events

Other events: 6 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Exemestane Therapy n=6 participants at risk Exemestane: One 25 mg tablet once daily for a minimum of 6 weeks
Metabolism and nutrition disorders Dehydration	16.7% 1/6 • Number of events 1 • Monitoring for adverse events will begin with the start of the exemestane and continue through and including 28 calendar days after the last dose of exemestane, an average of 22 weeks.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	16.7% 1/6 • Number of events 1 • Monitoring for adverse events will begin with the start of the exemestane and continue through and including 28 calendar days after the last dose of exemestane, an average of 22 weeks.
Infections and infestations Sepsis	16.7% 1/6 • Number of events 1 • Monitoring for adverse events will begin with the start of the exemestane and continue through and including 28 calendar days after the last dose of exemestane, an average of 22 weeks.
Infections and infestations Skin infection	16.7% 1/6 • Number of events 1 • Monitoring for adverse events will begin with the start of the exemestane and continue through and including 28 calendar days after the last dose of exemestane, an average of 22 weeks.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specify	16.7% 1/6 • Number of events 1 • Monitoring for adverse events will begin with the start of the exemestane and continue through and including 28 calendar days after the last dose of exemestane, an average of 22 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	16.7% 1/6 • Number of events 1 • Monitoring for adverse events will begin with the start of the exemestane and continue through and including 28 calendar days after the last dose of exemestane, an average of 22 weeks.

Other adverse events

Other adverse events
Measure	Exemestane Therapy n=6 participants at risk Exemestane: One 25 mg tablet once daily for a minimum of 6 weeks
General disorders Edema limbs	60.0% 3/5 • Number of events 3 • Monitoring for adverse events will begin with the start of the exemestane and continue through and including 28 calendar days after the last dose of exemestane, an average of 22 weeks.
General disorders Pain	40.0% 2/5 • Number of events 2 • Monitoring for adverse events will begin with the start of the exemestane and continue through and including 28 calendar days after the last dose of exemestane, an average of 22 weeks.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	20.0% 1/5 • Number of events 1 • Monitoring for adverse events will begin with the start of the exemestane and continue through and including 28 calendar days after the last dose of exemestane, an average of 22 weeks.
Investigations Weight gain	20.0% 1/5 • Number of events 1 • Monitoring for adverse events will begin with the start of the exemestane and continue through and including 28 calendar days after the last dose of exemestane, an average of 22 weeks.
Metabolism and nutrition disorders Hypoalbuminemia	40.0% 2/5 • Number of events 2 • Monitoring for adverse events will begin with the start of the exemestane and continue through and including 28 calendar days after the last dose of exemestane, an average of 22 weeks.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	20.0% 1/5 • Number of events 1 • Monitoring for adverse events will begin with the start of the exemestane and continue through and including 28 calendar days after the last dose of exemestane, an average of 22 weeks.
Blood and lymphatic system disorders Anemia	60.0% 3/5 • Number of events 11 • Monitoring for adverse events will begin with the start of the exemestane and continue through and including 28 calendar days after the last dose of exemestane, an average of 22 weeks.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	20.0% 1/5 • Number of events 1 • Monitoring for adverse events will begin with the start of the exemestane and continue through and including 28 calendar days after the last dose of exemestane, an average of 22 weeks.
Eye disorders Eye disorders - Other, specify	20.0% 1/5 • Number of events 1 • Monitoring for adverse events will begin with the start of the exemestane and continue through and including 28 calendar days after the last dose of exemestane, an average of 22 weeks.
Gastrointestinal disorders Abdominal pain	20.0% 1/5 • Number of events 1 • Monitoring for adverse events will begin with the start of the exemestane and continue through and including 28 calendar days after the last dose of exemestane, an average of 22 weeks.
Gastrointestinal disorders Diarrhea	20.0% 1/5 • Number of events 2 • Monitoring for adverse events will begin with the start of the exemestane and continue through and including 28 calendar days after the last dose of exemestane, an average of 22 weeks.
General disorders Fatigue	20.0% 1/5 • Number of events 1 • Monitoring for adverse events will begin with the start of the exemestane and continue through and including 28 calendar days after the last dose of exemestane, an average of 22 weeks.
General disorders General disorders and administration site conditions - Other, specify	20.0% 1/5 • Number of events 1 • Monitoring for adverse events will begin with the start of the exemestane and continue through and including 28 calendar days after the last dose of exemestane, an average of 22 weeks.
Immune system disorders Immune system disorders - Other, specify	20.0% 1/5 • Number of events 2 • Monitoring for adverse events will begin with the start of the exemestane and continue through and including 28 calendar days after the last dose of exemestane, an average of 22 weeks.
Infections and infestations Sepsis	20.0% 1/5 • Number of events 1 • Monitoring for adverse events will begin with the start of the exemestane and continue through and including 28 calendar days after the last dose of exemestane, an average of 22 weeks.
Infections and infestations Upper respiratory infection	40.0% 2/5 • Number of events 2 • Monitoring for adverse events will begin with the start of the exemestane and continue through and including 28 calendar days after the last dose of exemestane, an average of 22 weeks.
Infections and infestations Urinary tract infection	20.0% 1/5 • Number of events 1 • Monitoring for adverse events will begin with the start of the exemestane and continue through and including 28 calendar days after the last dose of exemestane, an average of 22 weeks.
Investigations Alanine aminotransferase increased	20.0% 1/5 • Number of events 15 • Monitoring for adverse events will begin with the start of the exemestane and continue through and including 28 calendar days after the last dose of exemestane, an average of 22 weeks.
Investigations Alkaline phosphatase increased	20.0% 1/5 • Number of events 5 • Monitoring for adverse events will begin with the start of the exemestane and continue through and including 28 calendar days after the last dose of exemestane, an average of 22 weeks.
Investigations Aspartate aminotransferase increased	20.0% 1/5 • Number of events 8 • Monitoring for adverse events will begin with the start of the exemestane and continue through and including 28 calendar days after the last dose of exemestane, an average of 22 weeks.
Investigations Blood bilirubin increased	20.0% 1/5 • Number of events 2 • Monitoring for adverse events will begin with the start of the exemestane and continue through and including 28 calendar days after the last dose of exemestane, an average of 22 weeks.
Investigations Cardiac troponin I increased	20.0% 1/5 • Number of events 1 • Monitoring for adverse events will begin with the start of the exemestane and continue through and including 28 calendar days after the last dose of exemestane, an average of 22 weeks.
Investigations Lymphocyte count decreased	20.0% 1/5 • Number of events 3 • Monitoring for adverse events will begin with the start of the exemestane and continue through and including 28 calendar days after the last dose of exemestane, an average of 22 weeks.
Metabolism and nutrition disorders Hyponatremia	20.0% 1/5 • Number of events 3 • Monitoring for adverse events will begin with the start of the exemestane and continue through and including 28 calendar days after the last dose of exemestane, an average of 22 weeks.
Musculoskeletal and connective tissue disorders Pain in extremity	20.0% 1/5 • Number of events 1 • Monitoring for adverse events will begin with the start of the exemestane and continue through and including 28 calendar days after the last dose of exemestane, an average of 22 weeks.
Respiratory, thoracic and mediastinal disorders Dyspnea	20.0% 1/5 • Number of events 1 • Monitoring for adverse events will begin with the start of the exemestane and continue through and including 28 calendar days after the last dose of exemestane, an average of 22 weeks.
Respiratory, thoracic and mediastinal disorders Hypoxia	20.0% 1/5 • Number of events 1 • Monitoring for adverse events will begin with the start of the exemestane and continue through and including 28 calendar days after the last dose of exemestane, an average of 22 weeks.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	20.0% 1/5 • Number of events 2 • Monitoring for adverse events will begin with the start of the exemestane and continue through and including 28 calendar days after the last dose of exemestane, an average of 22 weeks.
Respiratory, thoracic and mediastinal disorders Wheezing	20.0% 1/5 • Number of events 1 • Monitoring for adverse events will begin with the start of the exemestane and continue through and including 28 calendar days after the last dose of exemestane, an average of 22 weeks.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	40.0% 2/5 • Number of events 2 • Monitoring for adverse events will begin with the start of the exemestane and continue through and including 28 calendar days after the last dose of exemestane, an average of 22 weeks.
Vascular disorders Hot flashes	20.0% 1/5 • Number of events 1 • Monitoring for adverse events will begin with the start of the exemestane and continue through and including 28 calendar days after the last dose of exemestane, an average of 22 weeks.
Vascular disorders Lymphedema	20.0% 1/5 • Number of events 1 • Monitoring for adverse events will begin with the start of the exemestane and continue through and including 28 calendar days after the last dose of exemestane, an average of 22 weeks.

Additional Information

Manish Patel, DO

University of Minnesota

Phone: 612-625-2654

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place