Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03566485
Previous Study | Return to List | Next Study

Atezolizumab and Cobimetinib or Idasanutlin in Participants With Stage IV or Unresectable Recurrent Estrogen Receptor Positive Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03566485
Recruitment Status : Terminated (Low accrual/Loss of funding)
First Posted : June 25, 2018
Results First Posted : August 11, 2021
Last Update Posted : August 11, 2021
Sponsor:
Collaborators:
Genentech, Inc.
Stand Up To Cancer
Information provided by (Responsible Party):
Ingrid Mayer, MD, Vanderbilt-Ingram Cancer Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Stage III Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Stage IV Breast Cancer
Estrogen Receptor-positive
HER2/Neu Negative
Interventions Drug: Atezolizumab
Drug: Cobimetinib
Drug: Idasanutlin
Enrollment 12
Recruitment Details Participants were recruited to this study from July 2018 to November 2019 at Vanderbilt-Ingram Cancer Center in Nashville, TN. This study stopped early due to low accrual.
Pre-assignment Details Twelve participants were enrolled onto this study.
Arm/Group Title Phase 2 (Atezolizumab, Cobimetinib) Phase 1b - (Atezolizumab, Idasanutlin)
Hide Arm/Group Description

Participants with TP53 gene mutation receive atezolizumab IV over 60 minutes starting with day 15 of course 1 and then on days 1 and 15 of subsequent courses, and cobimetinib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Atezolizumab: Given by IV

Cobimetinib: Given by mouth

Atezolizumab: Given by IV

Idasanutlin: Given by mouth

Period Title: Overall Study
Started 5 7 [1]
Completed 0 0
Not Completed 5 7
Reason Not Completed
Disease progression             5             4
Clinical progression             0             1
Toxicity             0             2
[1]
Dose level 1 (Idasanutlin 100mg PO)
Arm/Group Title Phase 2 (Atezolizumab, Cobimetinib) Phase 1b - (Atezolizumab, Idasanutlin) Total
Hide Arm/Group Description

Participants with TP53 gene mutation receive atezolizumab IV over 60 minutes starting with day 15 of course 1 and then on days 1 and 15 of subsequent courses, and cobimetinib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Atezolizumab: Given by IV

Cobimetinib: Given by mouth

Atezolizumab: Given by IV

Idasanutlin: Given by mouth

Total of all reporting groups
Overall Number of Baseline Participants 5 7 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 7 participants 12 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
  80.0%
5
  71.4%
9
  75.0%
>=65 years
1
  20.0%
2
  28.6%
3
  25.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 7 participants 12 participants
Female
5
 100.0%
7
 100.0%
12
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 7 participants 12 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
4
  80.0%
5
  71.4%
9
  75.0%
Unknown or Not Reported
1
  20.0%
2
  28.6%
3
  25.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 7 participants 12 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
4
  80.0%
5
  71.4%
9
  75.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
  20.0%
2
  28.6%
3
  25.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 7 participants 12 participants
5 7 12
1.Primary Outcome
Title Number of Participants With a Dose Limiting Toxicity (DLT) (Phase I)
Hide Description Assessment of DLT for the patients in the atezolizumab and idasanutiln arm of the study
Time Frame At 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients in the atezolizumab and idasanutiln arm of the study
Arm/Group Title Phase 1b - (Atezolizumab, Idasanutlin)
Hide Arm/Group Description:

Atezolizumab: Given by IV

Idasanutlin: Given by mouth

Overall Number of Participants Analyzed 7
Measure Type: Count of Participants
Unit of Measure: Participants
1
  14.3%
2.Primary Outcome
Title Maximum Tolerated Dose (Phase I)
Hide Description Assessment of MTD for the atezolizumab and idasanutiln combination arm of the study
Time Frame At 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Patients in the atezolizumab and idasanutiln combination arm of the study. Dosage used: Atezolizumab 840mg IV + Idasanutlin 100mg PO
Arm/Group Title Phase 1b - (Atezolizumab, Idasanutlin)
Hide Arm/Group Description:

Atezolizumab: Given by IV

Idasanutlin: Given by mouth

Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: mg
NA [1] 
[1]
Not enough patients were put on the Idasa + Atezo arm; therefore, unable to determine MTD. Dosage used: Atezolizumab 840mg IV + Idasanutlin 100mg PO.
3.Primary Outcome
Title Recommended Phase II Dose (Phase I)
Hide Description Assessment of recommended phase II dose for the atezolizumab and idasanutiln combination arm of the study
Time Frame At 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Patients on the atezolizumab and idasanutiln combination arm of the study. Dosage used: Atezolizumab 840mg IV + Idasanutlin 100mg PO.
Arm/Group Title Phase 1b - (Atezolizumab, Idasanutlin)
Hide Arm/Group Description:

Atezolizumab: Given by IV

Idasanutlin: Given by mouth

Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: mg
NA [1] 
[1]
Not enough patients were put on the Idasa + Atezo arm; therefore, unable to determine MTD and recommend dose for phase II. Dosage used: Atezolizumab 840mg IV + Idasanutlin 100mg PO. For phase II, no patients were assigned to this arm.
4.Primary Outcome
Title Overall Response Rate (ORR; by Response Evaluation Criteria in Solid Tumors [RECIST]1.1) (Phase II)
Hide Description

Assessment of clinical impact (anti-tumor effect) of the combination of atezolizumab and cobimetinib or idasanutiln in patients with metastatic ER

+ breast cancer by measure the rate (%) of complete and partial responses seen in patients with measurable disease. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) 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.

Time Frame Up to 28 days after completion of study treatment, for a total of 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients on Phase 2 Arm 1 (TP53-mut) - Atezolizumab 840mg IV + Cobimetinib 60mg PO
Arm/Group Title Phase 2 (Atezolizumab, Cobimetinib)
Hide Arm/Group Description:

Participants with TP53 gene mutation receive atezolizumab IV over 60 minutes starting with day 15 of course 1 and then on days 1 and 15 of subsequent courses, and cobimetinib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Atezolizumab: Given by IV

Cobimetinib: Given by mouth

Overall Number of Participants Analyzed 5
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
NA [1] 
(NA to NA)
[1]
Among the 5 participants, two patients had only baseline measurements, one patient had only follow up measurement, and one patient did not have any measurements. Only one patient had progressive disease after baseline measurement. Therefore, not enough number of patients for calculating this outcome.
5.Secondary Outcome
Title Clinical Benefit Rate (CBR) (Phase II)
Hide Description

Assessment of clinical impact (anti-tumor effect) of the combination of atezolizumab and cobimetinib or idasanutiln in patients with metastatic ER

+ breast cancer by measure the rate (%) of complete and partial responses + stability of disease at 6 months seen in patients with measurable disease. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) 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.

Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
patients on Phase 2 Arm 1 (TP53-mut) - Atezolizumab 840mg IV + Cobimetinib 60mg PO
Arm/Group Title Phase 2 (Atezolizumab, Cobimetinib)
Hide Arm/Group Description:

Participants with TP53 gene mutation receive atezolizumab IV over 60 minutes starting with day 15 of course 1 and then on days 1 and 15 of subsequent courses, and cobimetinib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Atezolizumab: Given by IV

Cobimetinib: Given by mouth

Overall Number of Participants Analyzed 5
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
NA [1] 
(NA to NA)
[1]
Among 5 participants, two patients had only baseline measurements, one patient had only follow up measurement, and one patient did not have any measurements. Only one patient had progressive disease after baseline measurement. Therefore, not enough number of patients for calculating this outcome.
6.Secondary Outcome
Title Immune Related Response Criteria (irRC) (Phase II)
Hide Description

Assessment of clinical impact (anti-tumor effect) of the combination of atezolizumab and cobimetinib or idasanutiln in patients with metastatic ER

+ breast cancer by measure the rate (%) of immune-related complete and partial responses seen in patients with measurable disease

Time Frame Up to 28 days after completion of study treatment, for a total of 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
An insufficient number of participants exhibited response for analysis.
Arm/Group Title Phase 2 (Atezolizumab, Cobimetinib)
Hide Arm/Group Description:

Participants with TP53 gene mutation receive atezolizumab IV over 60 minutes starting with day 15 of course 1 and then on days 1 and 15 of subsequent courses, and cobimetinib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Atezolizumab: Given by IV

Cobimetinib: Given by mouth

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Progression-free Survival (PFS) (Phase II) in Days
Hide Description

Assessment of clinical impact (anti-tumor effect) of the combination of atezolizumab and cobimetinib or idasanutiln in patients with metastatic ER

+ breast cancer by measuring the interval (in months) between treatment initiation and disease progression.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1).

Time Frame At 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients on Phase 2 Arm 1 (TP53-mut) - Atezolizumab 840mg IV + Cobimetinib 60mg PO
Arm/Group Title Phase 2 (Atezolizumab, Cobimetinib)
Hide Arm/Group Description:

Participants with TP53 gene mutation receive atezolizumab IV over 60 minutes starting with day 15 of course 1 and then on days 1 and 15 of subsequent courses, and cobimetinib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Atezolizumab: Given by IV

Cobimetinib: Given by mouth

Overall Number of Participants Analyzed 5
Median (95% Confidence Interval)
Unit of Measure: days
56 [1] 
(51 to NA)
[1]
Could not be estimated from the data due to insufficient number of participants with events
8.Secondary Outcome
Title Overall Survival (OS) (Phase II) in Days
Hide Description

Assessment of clinical impact (anti-tumor effect) of the combination of atezolizumab and cobimetinib or idasanutiln in patients with metastatic ER

+ breast cancer by measuring the interval (in months) between treatment initiation and death from any cause

Time Frame At 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients on Phase 2 Arm 1 (TP53-mut) - Atezolizumab 840mg IV + Cobimetinib 60mg PO
Arm/Group Title Phase 2 (Atezolizumab, Cobimetinib)
Hide Arm/Group Description:

Participants with TP53 gene mutation receive atezolizumab IV over 60 minutes starting with day 15 of course 1 and then on days 1 and 15 of subsequent courses, and cobimetinib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Atezolizumab: Given by IV

Cobimetinib: Given by mouth

Overall Number of Participants Analyzed 5
Median (95% Confidence Interval)
Unit of Measure: days
161 [1] 
(136 to NA)
[1]
Could not be estimated from the data due to insufficient number of participants with events.
9.Secondary Outcome
Title Number of Adverse Events (Phase II)
Hide Description Assessment of adverse events throughout the phase II study
Time Frame Up to 28 days after completion of study treatment, for a total of 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
patients on atezolizumab and cobimetinib.
Arm/Group Title Phase 2 (Atezolizumab, Cobimetinib)
Hide Arm/Group Description:

Participants with TP53 gene mutation receive atezolizumab IV over 60 minutes starting with day 15 of course 1 and then on days 1 and 15 of subsequent courses, and cobimetinib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Atezolizumab: Given by IV

Cobimetinib: Given by mouth

Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: events
99
Time Frame Initiation of study medication, throughout the study, and within 28 days (+/- 7 days) of the last dose of study medication, for a total of 2 years.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phase 2 (Atezolizumab, Cobimetinib) Phase 1b - (Atezolizumab, Idasanutlin)
Hide Arm/Group Description

Participants with TP53 gene mutation receive atezolizumab IV over 60 minutes starting with day 15 of course 1 and then on days 1 and 15 of subsequent courses, and cobimetinib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Atezolizumab: Given by IV

Cobimetinib: Given by mouth

Atezolizumab: Given by IV

Idasanutlin: Given by mouth

All-Cause Mortality
Phase 2 (Atezolizumab, Cobimetinib) Phase 1b - (Atezolizumab, Idasanutlin)
Affected / at Risk (%) Affected / at Risk (%)
Total   3/5 (60.00%)      3/7 (42.86%)    
Hide Serious Adverse Events
Phase 2 (Atezolizumab, Cobimetinib) Phase 1b - (Atezolizumab, Idasanutlin)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/5 (40.00%)      4/7 (57.14%)    
Blood and lymphatic system disorders     
Febrile neutropenia  1  0/5 (0.00%)  0 2/7 (28.57%)  2
Anemia  1  0/5 (0.00%)  0 1/7 (14.29%)  1
Gastrointestinal disorders     
Vomiting  1  0/5 (0.00%)  0 1/7 (14.29%)  1
Infections and infestations     
Strep infection  1  0/5 (0.00%)  0 1/7 (14.29%)  1
Lung infection  1  0/5 (0.00%)  0 1/7 (14.29%)  1
Investigations     
Neutrophil count decreased  1  1/5 (20.00%)  1 2/7 (28.57%)  2
Platelet count decrease  1  0/5 (0.00%)  0 2/7 (28.57%)  2
White blood cell decreased  1  0/5 (0.00%)  0 1/7 (14.29%)  1
Death  1 [1]  0/5 (0.00%)  0 1/7 (14.29%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/5 (20.00%)  1 0/7 (0.00%)  0
Back pain  1  1/5 (20.00%)  1 0/7 (0.00%)  0
Osteonecrosis  1  0/5 (0.00%)  0 1/7 (14.29%)  1
Psychiatric disorders     
Suicide  1  0/5 (0.00%)  0 1/7 (14.29%)  1
1
Term from vocabulary, CTCAE v5.0
Indicates events were collected by systematic assessment
[1]
Clinical progression
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Phase 2 (Atezolizumab, Cobimetinib) Phase 1b - (Atezolizumab, Idasanutlin)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/5 (100.00%)      7/7 (100.00%)    
Blood and lymphatic system disorders     
Anemia  1  4/5 (80.00%)  8 4/7 (57.14%)  5
Leukocytosis  1  0/5 (0.00%)  0 1/7 (14.29%)  1
Lymph node pain  1  1/5 (20.00%)  1 0/7 (0.00%)  0
Ear and labyrinth disorders     
Ear pain  1  0/5 (0.00%)  0 1/7 (14.29%)  1
Endocrine disorders     
Hypothyroidism  1  0/5 (0.00%)  0 1/7 (14.29%)  1
Eye disorders     
Blurred vison  1  0/5 (0.00%)  0 2/7 (28.57%)  2
Glaucoma  1  1/5 (20.00%)  1 0/7 (0.00%)  0
Retinopathy  1  1/5 (20.00%)  1 0/7 (0.00%)  0
Gastrointestinal disorders     
Diarrhea  1  3/5 (60.00%)  5 5/7 (71.43%)  9
Nausea  1  3/5 (60.00%)  5 5/7 (71.43%)  12
Vomiting  1  3/5 (60.00%)  7 4/7 (57.14%)  7
Constipation  1  2/5 (40.00%)  4 3/7 (42.86%)  4
Abdominal pain  1  1/5 (20.00%)  1 2/7 (28.57%)  3
Dyspepsia  1  0/5 (0.00%)  0 3/7 (42.86%)  9
Dry mouth  1  1/5 (20.00%)  1 1/7 (14.29%)  1
Dysphagia  1  1/5 (20.00%)  1 1/7 (14.29%)  1
Flatulence  1  1/5 (20.00%)  1 1/7 (14.29%)  1
Bloating  1  0/5 (0.00%)  0 1/7 (14.29%)  1
Esophagitis  1  0/5 (0.00%)  0 1/7 (14.29%)  1
Gingival pain  1  0/5 (0.00%)  0 1/7 (14.29%)  1
Mucositis oral  1  0/5 (0.00%)  0 1/7 (14.29%)  1
Tooth ache  1  1/5 (20.00%)  1 0/7 (0.00%)  0
General disorders     
Fatigue  1  3/5 (60.00%)  6 5/7 (71.43%)  9
Fever  1  1/5 (20.00%)  2 1/7 (14.29%)  1
Malaise  1  1/5 (20.00%)  1 1/7 (14.29%)  1
Non-cardiac chest pain  1  0/5 (0.00%)  0 1/7 (14.29%)  3
Pain  1  1/5 (20.00%)  1 0/7 (0.00%)  0
Hepatobiliary disorders     
Postnasal drip  1  0/5 (0.00%)  0 1/7 (14.29%)  1
Hepatic pain  1  2/5 (40.00%)  3 0/7 (0.00%)  0
Infections and infestations     
Sinusitis  1  1/5 (20.00%)  1 1/7 (14.29%)  1
Upper respiratory infection  1  2/5 (40.00%)  2 0/7 (0.00%)  0
Urinary tract infection  1  1/5 (20.00%)  1 1/7 (14.29%)  1
Bronchial infection  1  0/5 (0.00%)  0 1/7 (14.29%)  1
Skin infection  1  0/5 (0.00%)  0 1/7 (14.29%)  1
Injury, poisoning and procedural complications     
Blood bilirubin increased  1  0/5 (0.00%)  0 1/7 (14.29%)  1
Fall  1  1/5 (20.00%)  1 1/7 (14.29%)  1
Bruising  1  0/5 (0.00%)  0 1/7 (14.29%)  1
Investigations     
Lymphocyte count decreased  1  4/5 (80.00%)  9 4/7 (57.14%)  12
White blood cell decreased  1  3/5 (60.00%)  8 5/7 (71.43%)  13
Neutrophil count decreased  1  2/5 (40.00%)  3 2/7 (28.57%)  5
Aspartate aminotransferase increased  1  3/5 (60.00%)  6 3/7 (42.86%)  3
Platelet count decreased  1  1/5 (20.00%)  2 2/7 (28.57%)  12
Alanine aminotransferase increased  1  3/5 (60.00%)  6 1/7 (14.29%)  1
Alkaline phosphatase increased  1  1/5 (20.00%)  2 2/7 (28.57%)  3
Cholesterol high  1  0/5 (0.00%)  0 1/7 (14.29%)  1
GGT increased  1  1/5 (20.00%)  1 0/7 (0.00%)  0
INR increased  1  0/5 (0.00%)  0 1/7 (14.29%)  1
Lymphocyte count increased  1  0/5 (0.00%)  0 1/7 (14.29%)  1
Hypokalemia  1  3/5 (60.00%)  5 1/7 (14.29%)  1
Metabolism and nutrition disorders     
Anorexia  1  3/5 (60.00%)  4 4/7 (57.14%)  7
Hyperglycemia  1  2/5 (40.00%)  5 4/7 (57.14%)  10
Hypoalbuminemia  1  2/5 (40.00%)  6 2/7 (28.57%)  2
Dehydration  1  1/5 (20.00%)  1 2/7 (28.57%)  3
Hypocalcemia  1  1/5 (20.00%)  1 2/7 (28.57%)  3
Hyponatremia  1  1/5 (20.00%)  1 1/7 (14.29%)  1
Hypercalcemia  1  1/5 (20.00%)  4 0/7 (0.00%)  0
Hyperuricemia  1  1/5 (20.00%)  1 0/7 (0.00%)  0
Hypomagnesemia  1  1/5 (20.00%)  1 0/7 (0.00%)  0
Hypophosphatemia  1  1/5 (20.00%)  2 0/7 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  1  2/5 (40.00%)  6 2/7 (28.57%)  3
Back pain  1  1/5 (20.00%)  3 2/7 (28.57%)  2
Flank pain  1  0/5 (0.00%)  0 1/7 (14.29%)  2
Myalgia  1  0/5 (0.00%)  0 1/7 (14.29%)  1
Neck pain  1  1/5 (20.00%)  1 0/7 (0.00%)  0
Pain in extremity  1  0/5 (0.00%)  0 1/7 (14.29%)  1
Nervous system disorders     
Headache  1  1/5 (20.00%)  1 3/7 (42.86%)  5
Dysgeusia  1  2/5 (40.00%)  3 1/7 (14.29%)  1
Peripheral sensory neuropathy  1  0/5 (0.00%)  0 2/7 (28.57%)  2
Dizziness  1  0/5 (0.00%)  0 1/7 (14.29%)  1
Neuralgia  1  0/5 (0.00%)  0 1/7 (14.29%)  1
Psychiatric disorders     
Insomnia  1  0/5 (0.00%)  0 2/7 (28.57%)  2
Depression  1  0/5 (0.00%)  0 1/7 (14.29%)  2
Renal and urinary disorders     
Hematuria  1  0/5 (0.00%)  0 1/7 (14.29%)  1
Urinary tract obstruction  1  0/5 (0.00%)  0 1/7 (14.29%)  3
Reproductive system and breast disorders     
Pelvic pain  1  0/5 (0.00%)  0 1/7 (14.29%)  1
Vaginal dryness  1  0/5 (0.00%)  0 1/7 (14.29%)  1
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/5 (20.00%)  2/7 (28.57%)  2
Dyspnea  1  1/5 (20.00%)  1 2/7 (28.57%)  3
Productive cough  1  1/5 (20.00%)  1 1/7 (14.29%)  1
Sore throat  1  0/5 (0.00%)  0 2/7 (28.57%)  3
Epistaxis  1  1/5 (20.00%)  1 0/7 (0.00%)  0
Pleural effusion  1  1/5 (20.00%)  1 0/7 (0.00%)  0
Pulmonary edema  1  1/5 (20.00%)  1 0/7 (0.00%)  0
Skin and subcutaneous tissue disorders     
Pruritus  1  1/5 (20.00%)  2 1/7 (14.29%)  1
Rash maculo-papular  1  0/5 (0.00%)  0 2/7 (28.57%)  4
Alopecia  1  0/5 (0.00%)  0 1/7 (14.29%)  1
Dry skin  1  1/5 (20.00%)  2 0/7 (0.00%)  0
Hyperhidrosis  1  0/5 (0.00%)  0 1/7 (14.29%)  1
Rash acneiform  1  1/5 (20.00%)  1 0/7 (0.00%)  0
Scalp pain  1  1/5 (20.00%)  1 0/7 (0.00%)  0
1
Term from vocabulary, CTCAE v5.0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Teresa Melton
Organization: Vanderbilt-Ingram Cancer Center
Phone: 6159367423
EMail: teresa.melton@vumc.org
Layout table for additonal information
Responsible Party: Ingrid Mayer, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT03566485    
Other Study ID Numbers: VICC BRE 17107
NCI-2018-01159 ( Registry Identifier: NCI, Clinical Trials Reporting Program )
First Submitted: June 11, 2018
First Posted: June 25, 2018
Results First Submitted: June 10, 2021
Results First Posted: August 11, 2021
Last Update Posted: August 11, 2021