Trial Outcomes & Findings for Aromatase Inhibitor and Durvalumab in Postmenopausal Breast Cancer (NCT NCT03874325)

Last Updated: 2022-05-31

Results Overview

Modified preoperative endocrine prognostic index (mPEPI) of 0. Total PEPI score assigned to each patient is the sum of the risk points derived from the pathological (pT) stage, lymph node (pN) stage, Ki67 level, and estrogen receptor (ER) status of the surgical specimen. A hazard ratio (HR) in the range of 1-2 receives one risk point; a HR in the 2-2.5 range, two risk points; a HR greater than 2.5, three risk points. mPEPI score of 0 indicates a tumor size of 5 cm or less, negative lymph nodes, and Ki67 (proliferation index) of less than or equal to 2.7%. Drug combination will be determined to be efficacious if 7 or more participants achieve an mPEPI of 0.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

17 participants

Primary outcome timeframe

6 months

Results posted on

2022-05-31

Participant Flow

Participant milestones

Participant milestones
Measure	Safety Run In: Durvalumab + Aromatase Inhibitor Participants will be administered 1500 mg Durvalumab intravenously every 4 weeks for 6 cycles. Participants will also take standard of care 1 mg anastrozole daily by mouth for 6 months. Letrozole 2.5 mg or exemastane 25 mg may be substituted for anastrozole if an intolerance to anastrozole is exhibited. Six participants will be enrolled in the safety run in stage. If 1 or fewer of six participants have a DLT, expansion stage will open to enrollment. Durvalumab: 1500 mg Durvalumab will be administered intravenously every 4 weeks for 6 months. Anastrozole 1mg: Participants will self administer 1 mg anastrozole by mouth daily for 6 months. Letrozole 2.5mg: Participants intolerant to anastrozole will self administer 2.5 mg letrozole by mouth daily for 6 months. Exemestane may be substituted. Exemestane 25 MG: Participants intolerant to anastrozole will self administer 25 mg exemestane by mouth daily for 6 months. Letrozole may be substituted.	Expansion: Durvalumab + Aromatase Inhibitor Participants will be administered 1500 mg Durvalumab intravenously every 4 weeks for 6 cycles. Participants will also take standard of care 1 mg anastrozole daily by mouth for 6 months. Letrozole 2.5 mg or exemastane 25 mg may be substituted for anastrozole if an intolerance to anastrozole is exhibited. Durvalumab: 1500 mg Durvalumab will be administered intravenously every 4 weeks for 6 months. Anastrozole 1mg: Participants will self administer 1 mg anastrozole by mouth daily for 6 months. Letrozole 2.5mg: Participants intolerant to anastrozole will self administer 2.5 mg letrozole by mouth daily for 6 months. Exemestane may be substituted. Exemestane 25 MG: Participants intolerant to anastrozole will self administer 25 mg exemestane by mouth daily for 6 months. Letrozole may be substituted.
Overall Study STARTED	17	0
Overall Study COMPLETED	17	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Aromatase Inhibitor and Durvalumab in Postmenopausal Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Safety Run In: Durvalumab + Aromatase Inhibitor n=17 Participants Study terminated early and did not move beyond safety run in. Participants administered 1500 mg Durvalumab intravenously every 4 weeks for 6 cycles. Participants took standard of care 1 mg anastrozole daily by mouth for 6 months. Letrozole 2.5 mg or exemastane 25 mg may be substituted for anastrozole if an intolerance to anastrozole is exhibited. Six participants will be enrolled in the safety run in stage. If 1 or fewer of six participants have a DLT, expansion stage will open to enrollment. Durvalumab: 1500 mg Durvalumab will be administered intravenously every 4 weeks for 6 months. Anastrozole 1mg: Participants will self administer 1 mg anastrozole by mouth daily for 6 months. Letrozole 2.5mg: Participants intolerant to anastrozole will self administer 2.5 mg letrozole by mouth daily for 6 months. Exemestane may be substituted. Exemestane 25 MG: Participants intolerant to anastrozole will self administer 25 mg exemestane by mouth daily for 6 months. Letrozole may be substituted.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=93 Participants
Age, Categorical >=65 years	11 Participants n=93 Participants
Sex: Female, Male Female	17 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants
Race (NIH/OMB) White	14 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants
Region of Enrollment United States	17 participants n=93 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Safety Run In: Durvalumab + Aromatase Inhibitor n=17 Participants Participants will be administered 1500 mg Durvalumab intravenously every 4 weeks for 6 cycles. Participants will also take standard of care 1 mg anastrozole daily by mouth for 6 months. Letrozole 2.5 mg or exemastane 25 mg may be substituted for anastrozole if an intolerance to anastrozole is exhibited. Six participants will be enrolled in the safety run in stage. If 1 or fewer of six participants have a DLT, expansion stage will open to enrollment. Durvalumab: 1500 mg Durvalumab will be administered intravenously every 4 weeks for 6 months. Anastrozole 1mg: Participants will self administer 1 mg anastrozole by mouth daily for 6 months. Letrozole 2.5mg: Participants intolerant to anastrozole will self administer 2.5 mg letrozole by mouth daily for 6 months. Exemestane may be substituted. Exemestane 25 MG: Participants intolerant to anastrozole will self administer 25 mg exemestane by mouth daily for 6 months. Letrozole may be substituted.
Rate of Modified Preoperative Endocrine Prognostic Index (mPEPI) Score of 0	17.65 percentage of participants Interval 3.8 to 43.43

SECONDARY outcome

Timeframe: 6 months

Clinical Complete response: Palpable lesion(s) identified at baseline are no longer palpable and there are no new lesion(s) or other signs of disease progression.

Outcome measures

Outcome measures
Measure	Safety Run In: Durvalumab + Aromatase Inhibitor n=17 Participants Participants will be administered 1500 mg Durvalumab intravenously every 4 weeks for 6 cycles. Participants will also take standard of care 1 mg anastrozole daily by mouth for 6 months. Letrozole 2.5 mg or exemastane 25 mg may be substituted for anastrozole if an intolerance to anastrozole is exhibited. Six participants will be enrolled in the safety run in stage. If 1 or fewer of six participants have a DLT, expansion stage will open to enrollment. Durvalumab: 1500 mg Durvalumab will be administered intravenously every 4 weeks for 6 months. Anastrozole 1mg: Participants will self administer 1 mg anastrozole by mouth daily for 6 months. Letrozole 2.5mg: Participants intolerant to anastrozole will self administer 2.5 mg letrozole by mouth daily for 6 months. Exemestane may be substituted. Exemestane 25 MG: Participants intolerant to anastrozole will self administer 25 mg exemestane by mouth daily for 6 months. Letrozole may be substituted.
Clinical Complete Response (CR)	58.8 percentage of patients

SECONDARY outcome

Timeframe: 6 months

Clinical Partial response: A reduction in the product of the two largest perpendicular diameters of the primary tumor by 50% or more.

Outcome measures

Outcome measures
Measure	Safety Run In: Durvalumab + Aromatase Inhibitor n=17 Participants Participants will be administered 1500 mg Durvalumab intravenously every 4 weeks for 6 cycles. Participants will also take standard of care 1 mg anastrozole daily by mouth for 6 months. Letrozole 2.5 mg or exemastane 25 mg may be substituted for anastrozole if an intolerance to anastrozole is exhibited. Six participants will be enrolled in the safety run in stage. If 1 or fewer of six participants have a DLT, expansion stage will open to enrollment. Durvalumab: 1500 mg Durvalumab will be administered intravenously every 4 weeks for 6 months. Anastrozole 1mg: Participants will self administer 1 mg anastrozole by mouth daily for 6 months. Letrozole 2.5mg: Participants intolerant to anastrozole will self administer 2.5 mg letrozole by mouth daily for 6 months. Exemestane may be substituted. Exemestane 25 MG: Participants intolerant to anastrozole will self administer 25 mg exemestane by mouth daily for 6 months. Letrozole may be substituted.
Clinical Partial Response (PR)	41.2 percentage of patients

Adverse Events

Safety Run In: Durvalumab + Aromatase Inhibitor

Serious events: 2 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Safety Run In: Durvalumab + Aromatase Inhibitor n=17 participants at risk Participants will be administered 1500 mg Durvalumab intravenously every 4 weeks for 6 cycles. Participants will also take standard of care 1 mg anastrozole daily by mouth for 6 months. Letrozole 2.5 mg or exemastane 25 mg may be substituted for anastrozole if an intolerance to anastrozole is exhibited. Six participants will be enrolled in the safety run in stage. If 1 or fewer of six participants have a DLT, expansion stage will open to enrollment. Durvalumab: 1500 mg Durvalumab will be administered intravenously every 4 weeks for 6 months. Anastrozole 1mg: Participants will self administer 1 mg anastrozole by mouth daily for 6 months. Letrozole 2.5mg: Participants intolerant to anastrozole will self administer 2.5 mg letrozole by mouth daily for 6 months. Exemestane may be substituted. Exemestane 25 MG: Participants intolerant to anastrozole will self administer 25 mg exemestane by mouth daily for 6 months. Letrozole may be substituted.
Respiratory, thoracic and mediastinal disorders Pneumonitis	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Gastrointestinal disorders Diarrhea	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Gastrointestinal disorders Vomitting	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months

Other adverse events

Other adverse events
Measure	Safety Run In: Durvalumab + Aromatase Inhibitor n=17 participants at risk Participants will be administered 1500 mg Durvalumab intravenously every 4 weeks for 6 cycles. Participants will also take standard of care 1 mg anastrozole daily by mouth for 6 months. Letrozole 2.5 mg or exemastane 25 mg may be substituted for anastrozole if an intolerance to anastrozole is exhibited. Six participants will be enrolled in the safety run in stage. If 1 or fewer of six participants have a DLT, expansion stage will open to enrollment. Durvalumab: 1500 mg Durvalumab will be administered intravenously every 4 weeks for 6 months. Anastrozole 1mg: Participants will self administer 1 mg anastrozole by mouth daily for 6 months. Letrozole 2.5mg: Participants intolerant to anastrozole will self administer 2.5 mg letrozole by mouth daily for 6 months. Exemestane may be substituted. Exemestane 25 MG: Participants intolerant to anastrozole will self administer 25 mg exemestane by mouth daily for 6 months. Letrozole may be substituted.
General disorders Fatigue	70.6% 12/17 • Number of events 17 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
General disorders Pain	23.5% 4/17 • Number of events 7 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
General disorders Edema limbs	11.8% 2/17 • Number of events 2 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
General disorders Non-cardiac chest pain	11.8% 2/17 • Number of events 3 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
General disorders Chills	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
General disorders Facial pain	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
General disorders General disorders and administration site conditions - Other	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
General disorders Localized edema	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
General disorders Neck edema	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Musculoskeletal and connective tissue disorders Arthralgia	52.9% 9/17 • Number of events 13 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Musculoskeletal and connective tissue disorders Bone pain	11.8% 2/17 • Number of events 2 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Musculoskeletal and connective tissue disorders Myalgia	11.8% 2/17 • Number of events 3 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Musculoskeletal and connective tissue disorders Pain in extremity	11.8% 2/17 • Number of events 3 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Musculoskeletal and connective tissue disorders Back pain	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Musculoskeletal and connective tissue disorders Chest wall pain	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Musculoskeletal and connective tissue disorders Joint range of motion decreased	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Musculoskeletal and connective tissue disorders Muscle cramp	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Injury, poisoning and procedural complications Bruising	23.5% 4/17 • Number of events 4 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Injury, poisoning and procedural complications Fall	11.8% 2/17 • Number of events 2 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Injury, poisoning and procedural complications Intraoperative breast injury	11.8% 2/17 • Number of events 2 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Injury, poisoning and procedural complications Dermatitis radiation	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Injury, poisoning and procedural complications Infusion related reaction	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Injury, poisoning and procedural complications Seroma	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Nervous system disorders Headache	47.1% 8/17 • Number of events 9 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Nervous system disorders Dizziness	23.5% 4/17 • Number of events 5 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Nervous system disorders Dysgeusia	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Nervous system disorders Peripheral sensory neuropathy	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Nervous system disorders Tremor	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Nervous system disorders Vasovagal reaction	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Gastrointestinal disorders Nausea	41.2% 7/17 • Number of events 9 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Gastrointestinal disorders Diarrhea	29.4% 5/17 • Number of events 7 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Gastrointestinal disorders Constipation	23.5% 4/17 • Number of events 4 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Gastrointestinal disorders Abdominal pain	11.8% 2/17 • Number of events 2 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Gastrointestinal disorders Dental caries	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Gastrointestinal disorders Dyspepsia	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Gastrointestinal disorders Gastroesophageal reflux disease	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Gastrointestinal disorders Gastrointestinal disorders - Other	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Gastrointestinal disorders Oral dysesthesia	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Gastrointestinal disorders Oral pain	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Gastrointestinal disorders Periodontal disease	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Skin and subcutaneous tissue disorders Alopecia	17.6% 3/17 • Number of events 3 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Skin and subcutaneous tissue disorders Pruritus	17.6% 3/17 • Number of events 4 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Skin and subcutaneous tissue disorders Dry skin	11.8% 2/17 • Number of events 2 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Skin and subcutaneous tissue disorders Rash maculo-papular	11.8% 2/17 • Number of events 2 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	11.8% 2/17 • Number of events 3 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Skin and subcutaneous tissue disorders Erythema multiforme	5.9% 1/17 • Number of events 2 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Skin and subcutaneous tissue disorders Hyperkeratosis	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Skin and subcutaneous tissue disorders Rash acneiform	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Skin and subcutaneous tissue disorders Skin ulceration	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Vascular disorders Hot flashes	47.1% 8/17 • Number of events 9 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Vascular disorders Hypotension	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Metabolism and nutrition disorders Anorexia	29.4% 5/17 • Number of events 5 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Metabolism and nutrition disorders Dehydration	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Metabolism and nutrition disorders Hyperkalemia	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Reproductive system and breast disorders Breast pain	29.4% 5/17 • Number of events 5 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Reproductive system and breast disorders Vaginal discharge	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Reproductive system and breast disorders Vaginal dryness	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Endocrine disorders Hypothyroidism	23.5% 4/17 • Number of events 5 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Endocrine disorders Hyperthyroidism	11.8% 2/17 • Number of events 2 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Endocrine disorders Endocrine disorders - Other	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Respiratory, thoracic and mediastinal disorders Cough	29.4% 5/17 • Number of events 7 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Respiratory, thoracic and mediastinal disorders Dyspnea	5.9% 1/17 • Number of events 3 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Respiratory, thoracic and mediastinal disorders Pneumonitis	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Respiratory, thoracic and mediastinal disorders Wheezing	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Infections and infestations Skin infection	11.8% 2/17 • Number of events 2 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Infections and infestations Herpes simplex reactivation	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Infections and infestations Tooth infection	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Psychiatric disorders Anxiety	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Psychiatric disorders Confusion	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Psychiatric disorders Depression	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Psychiatric disorders Insomnia	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Ear and labyrinth disorders Vertigo	11.8% 2/17 • Number of events 2 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Immune system disorders Allergic reaction	11.8% 2/17 • Number of events 2 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Cardiac disorders Palpitations	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Hepatobiliary disorders Gallbladder pain	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months
Renal and urinary disorders Cystitis noninfective	5.9% 1/17 • Number of events 1 • Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months

Additional Information

Hung Khong, MD

Moffit Cancer Center

Phone: 813-745-3828

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place