Trial Outcomes & Findings for Phase 2 Durvalumab (Medi4736) for Bacillus Calmette-Guérin (BCG) Refactory Urothelial Carcinoma in Situ of the Bladder (NCT NCT02901548)

Last Updated: 2022-07-29

Results Overview

Complete Response Rate at month six based on the week 26 mapping biopsy in BCG refractory CIS urothelial bladder cancer. The absence of CIS of bladder on the mapping biopsies after pathological review would be considered complete response to treatment.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

17 participants

Primary outcome timeframe

6 Months

Results posted on

2022-07-29

Participant Flow

Participant milestones

Participant milestones
Measure	Durvalumab Plus Cystoscopy Durvalumab: Fixed dose level IV infusion every 4 weeks for 13 study treatment cycles/infusions over 12 months/1 year. Cystoscopy with biopsy will be performed every 3 months to monitor the treatment response during this one year of treatment phase. It will be performed every 6 months during year 2 of the surveillance phase. Durvalumab: Durvalumab will be given every 4 weeks at 1500 mg/kg IV for total of 12 months/13 doses. Cystoscopy with Biopsy: Cystoscopy with biopsy and transurethral resection of the bladder tumor (TURBT) (if indicated) will be performed at baseline, month 3, 6, 9, 12, 18, and 24. The month 6 and 24 cystoscopy will be done in the operating room with mapping biopsy. Rest of the cystoscopic exam with biopsy will be performed in the out-patient office setting and if clinically indicated will be repeated in the operating room. Participants will be off study if any of the biopsies document muscle invasive (T2 or above) urothelial carcinoma. Participants will also be off study if their month 6, 9, 12, 18 biopsies show persistent (month 6) or recurrent CIS or invasive (T1 or above) urothelial carcinoma. Otherwise, participants will remain on study until after the month 24 mapping biopsy.
Overall Study STARTED	17
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Durvalumab Plus Cystoscopy Durvalumab: Fixed dose level IV infusion every 4 weeks for 13 study treatment cycles/infusions over 12 months/1 year. Cystoscopy with biopsy will be performed every 3 months to monitor the treatment response during this one year of treatment phase. It will be performed every 6 months during year 2 of the surveillance phase. Durvalumab: Durvalumab will be given every 4 weeks at 1500 mg/kg IV for total of 12 months/13 doses. Cystoscopy with Biopsy: Cystoscopy with biopsy and transurethral resection of the bladder tumor (TURBT) (if indicated) will be performed at baseline, month 3, 6, 9, 12, 18, and 24. The month 6 and 24 cystoscopy will be done in the operating room with mapping biopsy. Rest of the cystoscopic exam with biopsy will be performed in the out-patient office setting and if clinically indicated will be repeated in the operating room. Participants will be off study if any of the biopsies document muscle invasive (T2 or above) urothelial carcinoma. Participants will also be off study if their month 6, 9, 12, 18 biopsies show persistent (month 6) or recurrent CIS or invasive (T1 or above) urothelial carcinoma. Otherwise, participants will remain on study until after the month 24 mapping biopsy.
Overall Study Withdrew after month 3 biopsy showed persistent cancer	4

Baseline Characteristics

Phase 2 Durvalumab (Medi4736) for Bacillus Calmette-Guérin (BCG) Refactory Urothelial Carcinoma in Situ of the Bladder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Durvalumab Plus Cystoscopy n=17 Participants Durvalumab: Fixed dose level IV infusion every 4 weeks for 13 study treatment cycles/infusions over 12 months/1 year. Cystoscopy with biopsy will be performed every 3 months to monitor the treatment response during this one year of treatment phase. It will be performed every 6 months during year 2 of the surveillance phase. Durvalumab: Durvalumab will be given every 4 weeks at 1500 mg/kg IV for total of 12 months/13 doses. Cystoscopy with Biopsy: Cystoscopy with biopsy and transurethral resection of the bladder tumor (TURBT) (if indicated) will be performed at baseline, month 3, 6, 9, 12, 18, and 24. The month 6 and 24 cystoscopy will be done in the operating room with mapping biopsy. Rest of the cystoscopic exam with biopsy will be performed in the out-patient office setting and if clinically indicated will be repeated in the operating room. Participants will be off study if any of the biopsies document muscle invasive (T2 or above) urothelial carcinoma. Participants will also be off study if their month 6, 9, 12, 18 biopsies show persistent (month 6) or recurrent CIS or invasive (T1 or above) urothelial carcinoma. Otherwise, participants will remain on study until after the month 24 mapping biopsy.
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	15 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 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	17 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	17 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 Months

Population: Evaluable participants

Outcome measures

Outcome measures
Measure	Durvalumab Plus Cystoscopy n=13 Participants Durvalumab: Fixed dose level IV infusion every 4 weeks for 13 study treatment cycles/infusions over 12 months/1 year. Cystoscopy with biopsy will be performed every 3 months to monitor the treatment response during this one year of treatment phase. It will be performed every 6 months during year 2 of the surveillance phase. Durvalumab: Durvalumab will be given every 4 weeks at 1500 mg/kg IV for total of 12 months/13 doses. Cystoscopy with Biopsy: Cystoscopy with biopsy and transurethral resection of the bladder tumor (TURBT) (if indicated) will be performed at baseline, month 3, 6, 9, 12, 18, and 24. The month 6 and 24 cystoscopy will be done in the operating room with mapping biopsy. Rest of the cystoscopic exam with biopsy will be performed in the out-patient office setting and if clinically indicated will be repeated in the operating room. Participants will be off study if any of the biopsies document muscle invasive (T2 or above) urothelial carcinoma. Participants will also be off study if their month 6, 9, 12, 18 biopsies show persistent (month 6) or recurrent CIS or invasive (T1 or above) urothelial carcinoma. Otherwise, participants will remain on study until after the month 24 mapping biopsy.
Complete Response Rate at 6 Months	23.1 percentage of participants Interval 5.0 to 53.8

SECONDARY outcome

Timeframe: 24 Months

Population: Evaluable participants. Study was closed early due to futility.

Complete Response Rate at month 24 based on the week 104 mapping biopsy in BCG refractory CIS urothelial bladder cancer. The absence of CIS of bladder on the mapping biopsies after pathological review would be considered complete response to treatment.

Outcome measures

Outcome measures
Measure	Durvalumab Plus Cystoscopy n=13 Participants Durvalumab: Fixed dose level IV infusion every 4 weeks for 13 study treatment cycles/infusions over 12 months/1 year. Cystoscopy with biopsy will be performed every 3 months to monitor the treatment response during this one year of treatment phase. It will be performed every 6 months during year 2 of the surveillance phase. Durvalumab: Durvalumab will be given every 4 weeks at 1500 mg/kg IV for total of 12 months/13 doses. Cystoscopy with Biopsy: Cystoscopy with biopsy and transurethral resection of the bladder tumor (TURBT) (if indicated) will be performed at baseline, month 3, 6, 9, 12, 18, and 24. The month 6 and 24 cystoscopy will be done in the operating room with mapping biopsy. Rest of the cystoscopic exam with biopsy will be performed in the out-patient office setting and if clinically indicated will be repeated in the operating room. Participants will be off study if any of the biopsies document muscle invasive (T2 or above) urothelial carcinoma. Participants will also be off study if their month 6, 9, 12, 18 biopsies show persistent (month 6) or recurrent CIS or invasive (T1 or above) urothelial carcinoma. Otherwise, participants will remain on study until after the month 24 mapping biopsy.
Complete Response Rate at 24 Months	0 percentage of participants

Adverse Events

Durvalumab Plus Cystoscopy

Serious events: 5 serious events

Other events: 17 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Durvalumab Plus Cystoscopy n=17 participants at risk Durvalumab: Fixed dose level IV infusion every 4 weeks for 13 study treatment cycles/infusions over 12 months/1 year. Cystoscopy with biopsy will be performed every 3 months to monitor the treatment response during this one year of treatment phase. It will be performed every 6 months during year 2 of the surveillance phase. Durvalumab: Durvalumab will be given every 4 weeks at 1500 mg/kg IV for total of 12 months/13 doses. Cystoscopy with Biopsy: Cystoscopy with biopsy and transurethral resection of the bladder tumor (TURBT) (if indicated) will be performed at baseline, month 3, 6, 9, 12, 18, and 24. The month 6 and 24 cystoscopy will be done in the operating room with mapping biopsy. Rest of the cystoscopic exam with biopsy will be performed in the out-patient office setting and if clinically indicated will be repeated in the operating room. Participants will be off study if any of the biopsies document muscle invasive (T2 or above) urothelial carcinoma. Participants will also be off study if their month 6, 9, 12, 18 biopsies show persistent (month 6) or recurrent CIS or invasive (T1 or above) urothelial carcinoma. Otherwise, participants will remain on study until after the month 24 mapping biopsy.
Renal and urinary disorders Dysuria	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Renal and urinary disorders Urinary tract infection	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Musculoskeletal and connective tissue disorders Pain in extremity	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Skin and subcutaneous tissue disorders Rash muculo-papular	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Blood and lymphatic system disorders Anemia	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Vascular disorders Thromboembolic event	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
General disorders Cystoprstatectomy	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified - Other	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Nervous system disorders Stroke	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Nervous system disorders Nervous system disorders -Other	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Renal and urinary disorders Hematuria	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).

Other adverse events

Other adverse events
Measure	Durvalumab Plus Cystoscopy n=17 participants at risk Durvalumab: Fixed dose level IV infusion every 4 weeks for 13 study treatment cycles/infusions over 12 months/1 year. Cystoscopy with biopsy will be performed every 3 months to monitor the treatment response during this one year of treatment phase. It will be performed every 6 months during year 2 of the surveillance phase. Durvalumab: Durvalumab will be given every 4 weeks at 1500 mg/kg IV for total of 12 months/13 doses. Cystoscopy with Biopsy: Cystoscopy with biopsy and transurethral resection of the bladder tumor (TURBT) (if indicated) will be performed at baseline, month 3, 6, 9, 12, 18, and 24. The month 6 and 24 cystoscopy will be done in the operating room with mapping biopsy. Rest of the cystoscopic exam with biopsy will be performed in the out-patient office setting and if clinically indicated will be repeated in the operating room. Participants will be off study if any of the biopsies document muscle invasive (T2 or above) urothelial carcinoma. Participants will also be off study if their month 6, 9, 12, 18 biopsies show persistent (month 6) or recurrent CIS or invasive (T1 or above) urothelial carcinoma. Otherwise, participants will remain on study until after the month 24 mapping biopsy.
Investigations Investigations- Other	52.9% 9/17 • Number of events 12 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Investigations INR increased	17.6% 3/17 • Number of events 5 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Investigations Serum amylase increased	17.6% 3/17 • Number of events 4 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Investigations Alanine aminotransferase increased	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Investigations Alkaline phosphatase increased	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Investigations Aspartate aminotransferase increased	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Investigations Creatinine increased	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Investigations Electrocardiogram QT corrected interval prolonged	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Investigations GGT increased	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Investigations Lipase increased	5.9% 1/17 • Number of events 2 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Investigations Platelet count decreased	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Investigations Weight loss	5.9% 1/17 • Number of events 4 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Renal and urinary disorders Renal and urinary disorders - Other	35.3% 6/17 • Number of events 7 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Renal and urinary disorders Cystitis noninfective	5.9% 1/17 • Number of events 2 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Renal and urinary disorders Urinary frequency	5.9% 1/17 • Number of events 2 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Renal and urinary disorders Urinary incontinence	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Renal and urinary disorders Urinary retention	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Renal and urinary disorders Urinary urgency	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
General disorders Fatigue	41.2% 7/17 • Number of events 7 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
General disorders Edema limbs	5.9% 1/17 • Number of events 2 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
General disorders Infusion related reaction	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Musculoskeletal and connective tissue disorders Arthralgia	23.5% 4/17 • Number of events 7 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Musculoskeletal and connective tissue disorders Myalgia	11.8% 2/17 • Number of events 2 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Musculoskeletal and connective tissue disorders Arthritis	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Musculoskeletal and connective tissue disorders Bone pain	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Musculoskeletal and connective tissue disorders Neck pain	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Musculoskeletal and connective tissue disorders Pain in extremity	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Skin and subcutaneous tissue disorders Pruritus	11.8% 2/17 • Number of events 2 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Skin and subcutaneous tissue disorders Rash maculo-papular	11.8% 2/17 • Number of events 4 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders -Other	11.8% 2/17 • Number of events 2 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Skin and subcutaneous tissue disorders Periorbital edema	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Gastrointestinal disorders Diarrhea	29.4% 5/17 • Number of events 6 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Gastrointestinal disorders Constipation	11.8% 2/17 • Number of events 3 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Gastrointestinal disorders Nausea	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Gastrointestinal disorders Vomiting	5.9% 1/17 • Number of events 2 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Nervous system disorders Headache	11.8% 2/17 • Number of events 2 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Nervous system disorders Amnesia	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Nervous system disorders Dizziness	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Nervous system disorders Nervous system disorders - Other	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Nervous system disorders Peripheral sensory neuropathy	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Nervous system disorders Stroke	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Metabolism and nutrition disorders Hyperkalemia	11.8% 2/17 • Number of events 2 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Metabolism and nutrition disorders Hypomagnesemia	11.8% 2/17 • Number of events 2 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Metabolism and nutrition disorders Anorexia	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Metabolism and nutrition disorders Hyponatremia	5.9% 1/17 • Number of events 2 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Respiratory, thoracic and mediastinal disorders Cough	17.6% 3/17 • Number of events 3 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Respiratory, thoracic and mediastinal disorders Dyspnea	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Respiratory, thoracic and mediastinal disorders Sore throat	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Vascular disorders Hypertension	11.8% 2/17 • Number of events 3 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Vascular disorders Hot flashes	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Vascular disorders Hypotension	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Cardiac disorders Cardiac disorders - Other	11.8% 2/17 • Number of events 2 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Cardiac disorders Sinus tachycardia	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Endocrine disorders Hypothyroidism	17.6% 3/17 • Number of events 4 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Endocrine disorders Hyperthyroidism	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Infections and infestations Urinary tract infection	17.6% 3/17 • Number of events 5 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Infections and infestations Ottis externa	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Blood and lymphatic system disorders Anemia	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Blood and lymphatic system disorders Leykocytosis	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified - Other	11.8% 2/17 • Number of events 2 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Ear and labyrinth disorders Ear pain	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Ear and labyrinth disorders Hearing impaired	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Eye disorders Eye disorders -Other	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Injury, poisoning and procedural complications Wound complications	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).
Psychiatric disorders Insomnia	5.9% 1/17 • Number of events 1 • Adverse events collected from time of informed consent to 90 days after last dose of study drug. Adverse events are still being collected (one participant still on treatment).

Additional Information

Jingsong Zhang, MD, PhD

Moffitt Cancer Center

Phone: 813-745-6926

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place