Trial Outcomes & Findings for Ribociclib and Letrozole in Treating Patients With Relapsed ER Positive Ovarian, Fallopian Tube, Primary Peritoneal, or Endometrial Cancer (NCT NCT02657928)
NCT ID: NCT02657928
Last Updated: 2021-10-26
Results Overview
The percentage of patients who are progression-free at 12 weeks (PFS12) is defined as patients who are alive and progression free at 12 weeks. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
At 12 weeks
Results posted on
2021-10-26
Participant Flow
Participant milestones
| Measure |
Cohort A: Ovarian
Patients with ovarian, primary peritoneal, fallopian tube ACA receive ribociclib 400 mg PO daily and letrozole 2.5 mg PO daily on days 1-28.
|
Cohort B: Endometrial
Patients with endometrial cancer receive ribociclib 400 mg PO daily and letrozole 2.5 mg PO daily on days 1-28.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ribociclib and Letrozole in Treating Patients With Relapsed ER Positive Ovarian, Fallopian Tube, Primary Peritoneal, or Endometrial Cancer
Baseline characteristics by cohort
| Measure |
Cohort A: Ovarian
n=20 Participants
Patients with ovarian, primary peritoneal, fallopian tube ACA receive ribociclib 400 mg PO daily and letrozole 2.5 mg PO daily on days 1-28.
|
Cohort B: Endometrial
n=20 Participants
Patients with endometrial cancer receive ribociclib 400 mg PO daily and letrozole 2.5 mg PO daily on days 1-28.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
64.5 years
n=7 Participants
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
ECOG Performance Score
0
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
ECOG Performance Score
1
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
ECOG Performance Score
2
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 12 weeksPopulation: Per protocol analysis population: 19 evaluable patients per cohort
The percentage of patients who are progression-free at 12 weeks (PFS12) is defined as patients who are alive and progression free at 12 weeks. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
Outcome measures
| Measure |
Cohort A: Ovarian
n=19 Participants
Patients with ovarian, primary peritoneal, fallopian tube ACA receive ribociclib 400 mg PO daily and letrozole 2.5 mg PO daily on days 1-28.
|
Cohort B: Endometrial
n=19 Participants
Patients with endometrial cancer receive ribociclib 400 mg PO daily and letrozole 2.5 mg PO daily on days 1-28.
|
|---|---|---|
|
Percentage of Patients Alive and Free of Progression at 12 Weeks (PFS12)
|
52.6 percentage of patients
|
57.9 percentage of patients
|
SECONDARY outcome
Timeframe: From registration to the first of either disease progression or death from any cause, assessed up to 2 yearsProgression free survival (PFS) is defined as the time from the date of registration to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
Outcome measures
| Measure |
Cohort A: Ovarian
n=20 Participants
Patients with ovarian, primary peritoneal, fallopian tube ACA receive ribociclib 400 mg PO daily and letrozole 2.5 mg PO daily on days 1-28.
|
Cohort B: Endometrial
n=20 Participants
Patients with endometrial cancer receive ribociclib 400 mg PO daily and letrozole 2.5 mg PO daily on days 1-28.
|
|---|---|---|
|
Progression-free Survival
|
2.8 months
Interval 2.6 to 9.1
|
5.4 months
Interval 3.1 to 11.8
|
SECONDARY outcome
Timeframe: From registration to death from any cause, assessed up to 2 yearsOverall survival time is defined as the time from registration to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
Outcome measures
| Measure |
Cohort A: Ovarian
n=20 Participants
Patients with ovarian, primary peritoneal, fallopian tube ACA receive ribociclib 400 mg PO daily and letrozole 2.5 mg PO daily on days 1-28.
|
Cohort B: Endometrial
n=20 Participants
Patients with endometrial cancer receive ribociclib 400 mg PO daily and letrozole 2.5 mg PO daily on days 1-28.
|
|---|---|---|
|
Overall Survival
|
18.9 months
Interval 6.7 to
The 95% confidence interval upper limit was not evaluated (below the level of detection).
|
15.7 months
Interval 6.8 to
The 95% confidence interval upper limit was not evaluated (below the level of detection).
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Patients with CA-125 response data available with abnormal values at baseline are included in this analysis.
The number of patients with CA-125 response, defined as a 50% or greater reduction in baseline CA-125.
Outcome measures
| Measure |
Cohort A: Ovarian
n=27 Participants
Patients with ovarian, primary peritoneal, fallopian tube ACA receive ribociclib 400 mg PO daily and letrozole 2.5 mg PO daily on days 1-28.
|
Cohort B: Endometrial
Patients with endometrial cancer receive ribociclib 400 mg PO daily and letrozole 2.5 mg PO daily on days 1-28.
|
|---|---|---|
|
The Number of Patients With CA-125 Response
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 2 yearsThe number of patients with confirmed response (complete response or partial response) using Response Evaluation Criteria in Solid Tumors version 1.1. 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
Outcome measures
| Measure |
Cohort A: Ovarian
n=20 Participants
Patients with ovarian, primary peritoneal, fallopian tube ACA receive ribociclib 400 mg PO daily and letrozole 2.5 mg PO daily on days 1-28.
|
Cohort B: Endometrial
n=20 Participants
Patients with endometrial cancer receive ribociclib 400 mg PO daily and letrozole 2.5 mg PO daily on days 1-28.
|
|---|---|---|
|
The Number of Patients With Confirmed Response (Complete Response or Partial Response)
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 30 days post-treatmentThe number of treatment-related Grade 3 or higher adverse events using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Outcome measures
| Measure |
Cohort A: Ovarian
n=40 Participants
Patients with ovarian, primary peritoneal, fallopian tube ACA receive ribociclib 400 mg PO daily and letrozole 2.5 mg PO daily on days 1-28.
|
Cohort B: Endometrial
Patients with endometrial cancer receive ribociclib 400 mg PO daily and letrozole 2.5 mg PO daily on days 1-28.
|
|---|---|---|
|
The Number of Treatment-related Grade 3 or Higher Adverse Events
Grade 3 : Lymphopenia
|
5 events
|
—
|
|
The Number of Treatment-related Grade 3 or Higher Adverse Events
Grade 3 : Leukopenia
|
8 events
|
—
|
|
The Number of Treatment-related Grade 3 or Higher Adverse Events
Grade 3 : Neutropenia
|
6 events
|
—
|
|
The Number of Treatment-related Grade 3 or Higher Adverse Events
Grade 3 : Febrile Neutropenia
|
0 events
|
—
|
|
The Number of Treatment-related Grade 3 or Higher Adverse Events
Grade 3 : Fatigue
|
2 events
|
—
|
|
The Number of Treatment-related Grade 3 or Higher Adverse Events
Grade 3 : Liver Enzymes
|
3 events
|
—
|
|
The Number of Treatment-related Grade 3 or Higher Adverse Events
Grade 4 : Lymphopenia
|
1 events
|
—
|
|
The Number of Treatment-related Grade 3 or Higher Adverse Events
Grade 4 : Leukopenia
|
0 events
|
—
|
|
The Number of Treatment-related Grade 3 or Higher Adverse Events
Grade 4 : Neutropenia
|
0 events
|
—
|
|
The Number of Treatment-related Grade 3 or Higher Adverse Events
Grade 4 : Febrile Neutropenia
|
1 events
|
—
|
|
The Number of Treatment-related Grade 3 or Higher Adverse Events
Grade 4 : Fatigue
|
0 events
|
—
|
|
The Number of Treatment-related Grade 3 or Higher Adverse Events
Grade 4 : Liver Enzymes
|
0 events
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 days following treatment initiationXenograft will be created on each patient. For patient derived xenograft experiments, response to therapy will be based on tumor volumes measured by ultrasound. Tumor growth curves will be plotted graphically and notated to indicate the outcome status of the originating patients. End of study tumor volumes will be correlated with outcome status of the originating patient as well.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineWhether response rates to letrozole and ribociclib in patient derived xenograft avatars correlate to responses noted in the patients will be determined. Fisher's Exact test will be used to measure the associations.
Outcome measures
Outcome data not reported
Adverse Events
Cohort A: Ovarian
Serious events: 6 serious events
Other events: 18 other events
Deaths: 10 deaths
Cohort B: Endometrial
Serious events: 10 serious events
Other events: 19 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Cohort A: Ovarian
n=20 participants at risk
Patients with ovarian, primary peritoneal, fallopian tube ACA receive ribociclib 400 mg PO daily and letrozole 2.5 mg PO daily on days 1-28.
|
Cohort B: Endometrial
n=20 participants at risk
Patients with endometrial cancer receive ribociclib 400 mg PO daily and letrozole 2.5 mg PO daily on days 1-28.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/20 • Up to 30 days post-treatment
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
0.00%
0/20 • Up to 30 days post-treatment
|
|
Gastrointestinal disorders
Nausea
|
10.0%
2/20 • Number of events 2 • Up to 30 days post-treatment
|
0.00%
0/20 • Up to 30 days post-treatment
|
|
Gastrointestinal disorders
Rectal fistula
|
0.00%
0/20 • Up to 30 days post-treatment
|
5.0%
1/20 • Number of events 2 • Up to 30 days post-treatment
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/20 • Up to 30 days post-treatment
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
0.00%
0/20 • Up to 30 days post-treatment
|
|
General disorders
Fatigue
|
5.0%
1/20 • Number of events 2 • Up to 30 days post-treatment
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/20 • Up to 30 days post-treatment
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
|
Infections and infestations
Sepsis
|
0.00%
0/20 • Up to 30 days post-treatment
|
10.0%
2/20 • Number of events 2 • Up to 30 days post-treatment
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/20 • Up to 30 days post-treatment
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
|
Investigations
Lymphocyte count decreased
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
10.0%
2/20 • Number of events 2 • Up to 30 days post-treatment
|
|
Investigations
Neutrophil count decreased
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
0.00%
0/20 • Up to 30 days post-treatment
|
|
Investigations
Platelet count decreased
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
0.00%
0/20 • Up to 30 days post-treatment
|
|
Investigations
White blood cell decreased
|
0.00%
0/20 • Up to 30 days post-treatment
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/20 • Up to 30 days post-treatment
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/20 • Up to 30 days post-treatment
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/20 • Up to 30 days post-treatment
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
0.00%
0/20 • Up to 30 days post-treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/20 • Up to 30 days post-treatment
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/20 • Up to 30 days post-treatment
|
10.0%
2/20 • Number of events 2 • Up to 30 days post-treatment
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
|
Reproductive system and breast disorders
Vaginal fistula
|
0.00%
0/20 • Up to 30 days post-treatment
|
5.0%
1/20 • Number of events 2 • Up to 30 days post-treatment
|
Other adverse events
| Measure |
Cohort A: Ovarian
n=20 participants at risk
Patients with ovarian, primary peritoneal, fallopian tube ACA receive ribociclib 400 mg PO daily and letrozole 2.5 mg PO daily on days 1-28.
|
Cohort B: Endometrial
n=20 participants at risk
Patients with endometrial cancer receive ribociclib 400 mg PO daily and letrozole 2.5 mg PO daily on days 1-28.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
35.0%
7/20 • Number of events 25 • Up to 30 days post-treatment
|
25.0%
5/20 • Number of events 23 • Up to 30 days post-treatment
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
0.00%
0/20 • Up to 30 days post-treatment
|
|
Cardiac disorders
Atrial fibrillation
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
0.00%
0/20 • Up to 30 days post-treatment
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/20 • Up to 30 days post-treatment
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
0.00%
0/20 • Up to 30 days post-treatment
|
5.0%
1/20 • Number of events 6 • Up to 30 days post-treatment
|
|
Gastrointestinal disorders
Constipation
|
15.0%
3/20 • Number of events 8 • Up to 30 days post-treatment
|
10.0%
2/20 • Number of events 10 • Up to 30 days post-treatment
|
|
Gastrointestinal disorders
Diarrhea
|
30.0%
6/20 • Number of events 12 • Up to 30 days post-treatment
|
55.0%
11/20 • Number of events 27 • Up to 30 days post-treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/20 • Up to 30 days post-treatment
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/20 • Up to 30 days post-treatment
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
10.0%
2/20 • Number of events 10 • Up to 30 days post-treatment
|
15.0%
3/20 • Number of events 7 • Up to 30 days post-treatment
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
5.0%
1/20 • Number of events 4 • Up to 30 days post-treatment
|
5.0%
1/20 • Number of events 3 • Up to 30 days post-treatment
|
|
Gastrointestinal disorders
Mucositis oral
|
10.0%
2/20 • Number of events 4 • Up to 30 days post-treatment
|
35.0%
7/20 • Number of events 22 • Up to 30 days post-treatment
|
|
Gastrointestinal disorders
Nausea
|
20.0%
4/20 • Number of events 5 • Up to 30 days post-treatment
|
25.0%
5/20 • Number of events 15 • Up to 30 days post-treatment
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
0.00%
0/20 • Up to 30 days post-treatment
|
|
General disorders
Chills
|
0.00%
0/20 • Up to 30 days post-treatment
|
10.0%
2/20 • Number of events 12 • Up to 30 days post-treatment
|
|
General disorders
Edema limbs
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
|
General disorders
Fatigue
|
85.0%
17/20 • Number of events 101 • Up to 30 days post-treatment
|
85.0%
17/20 • Number of events 77 • Up to 30 days post-treatment
|
|
General disorders
Gait disturbance
|
0.00%
0/20 • Up to 30 days post-treatment
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
5.0%
1/20 • Number of events 2 • Up to 30 days post-treatment
|
10.0%
2/20 • Number of events 2 • Up to 30 days post-treatment
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/20 • Up to 30 days post-treatment
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/20 • Up to 30 days post-treatment
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
|
Investigations
Alanine aminotransferase increased
|
30.0%
6/20 • Number of events 12 • Up to 30 days post-treatment
|
40.0%
8/20 • Number of events 18 • Up to 30 days post-treatment
|
|
Investigations
Alkaline phosphatase increased
|
10.0%
2/20 • Number of events 22 • Up to 30 days post-treatment
|
25.0%
5/20 • Number of events 14 • Up to 30 days post-treatment
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
5/20 • Number of events 12 • Up to 30 days post-treatment
|
30.0%
6/20 • Number of events 12 • Up to 30 days post-treatment
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/20 • Up to 30 days post-treatment
|
10.0%
2/20 • Number of events 2 • Up to 30 days post-treatment
|
|
Investigations
Cholesterol high
|
10.0%
2/20 • Number of events 16 • Up to 30 days post-treatment
|
5.0%
1/20 • Number of events 3 • Up to 30 days post-treatment
|
|
Investigations
Creatinine increased
|
10.0%
2/20 • Number of events 17 • Up to 30 days post-treatment
|
15.0%
3/20 • Number of events 4 • Up to 30 days post-treatment
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
25.0%
5/20 • Number of events 10 • Up to 30 days post-treatment
|
15.0%
3/20 • Number of events 5 • Up to 30 days post-treatment
|
|
Investigations
GGT increased
|
0.00%
0/20 • Up to 30 days post-treatment
|
10.0%
2/20 • Number of events 4 • Up to 30 days post-treatment
|
|
Investigations
Investigations - Other, specify
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
|
Investigations
Lymphocyte count decreased
|
35.0%
7/20 • Number of events 44 • Up to 30 days post-treatment
|
50.0%
10/20 • Number of events 32 • Up to 30 days post-treatment
|
|
Investigations
Neutrophil count decreased
|
60.0%
12/20 • Number of events 68 • Up to 30 days post-treatment
|
60.0%
12/20 • Number of events 43 • Up to 30 days post-treatment
|
|
Investigations
Platelet count decreased
|
40.0%
8/20 • Number of events 26 • Up to 30 days post-treatment
|
15.0%
3/20 • Number of events 8 • Up to 30 days post-treatment
|
|
Investigations
White blood cell decreased
|
75.0%
15/20 • Number of events 82 • Up to 30 days post-treatment
|
85.0%
17/20 • Number of events 65 • Up to 30 days post-treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
20.0%
4/20 • Number of events 8 • Up to 30 days post-treatment
|
20.0%
4/20 • Number of events 9 • Up to 30 days post-treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.0%
2/20 • Number of events 2 • Up to 30 days post-treatment
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
|
Metabolism and nutrition disorders
Hypernatremia
|
10.0%
2/20 • Number of events 2 • Up to 30 days post-treatment
|
0.00%
0/20 • Up to 30 days post-treatment
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
10.0%
2/20 • Number of events 4 • Up to 30 days post-treatment
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.0%
2/20 • Number of events 2 • Up to 30 days post-treatment
|
0.00%
0/20 • Up to 30 days post-treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
10.0%
2/20 • Number of events 6 • Up to 30 days post-treatment
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/20 • Up to 30 days post-treatment
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
0.00%
0/20 • Up to 30 days post-treatment
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
2/20 • Number of events 33 • Up to 30 days post-treatment
|
10.0%
2/20 • Number of events 13 • Up to 30 days post-treatment
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/20 • Up to 30 days post-treatment
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
0.00%
0/20 • Up to 30 days post-treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
2/20 • Number of events 15 • Up to 30 days post-treatment
|
10.0%
2/20 • Number of events 3 • Up to 30 days post-treatment
|
|
Nervous system disorders
Dizziness
|
0.00%
0/20 • Up to 30 days post-treatment
|
10.0%
2/20 • Number of events 7 • Up to 30 days post-treatment
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/20 • Up to 30 days post-treatment
|
5.0%
1/20 • Number of events 3 • Up to 30 days post-treatment
|
|
Nervous system disorders
Headache
|
5.0%
1/20 • Number of events 7 • Up to 30 days post-treatment
|
0.00%
0/20 • Up to 30 days post-treatment
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
0.00%
0/20 • Up to 30 days post-treatment
|
|
Nervous system disorders
Paresthesia
|
5.0%
1/20 • Number of events 2 • Up to 30 days post-treatment
|
0.00%
0/20 • Up to 30 days post-treatment
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
0.00%
0/20 • Up to 30 days post-treatment
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
10.0%
2/20 • Number of events 3 • Up to 30 days post-treatment
|
10.0%
2/20 • Number of events 2 • Up to 30 days post-treatment
|
|
Psychiatric disorders
Confusion
|
0.00%
0/20 • Up to 30 days post-treatment
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
|
Psychiatric disorders
Insomnia
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
5.0%
1/20 • Number of events 6 • Up to 30 days post-treatment
|
|
Psychiatric disorders
Restlessness
|
5.0%
1/20 • Number of events 2 • Up to 30 days post-treatment
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
|
Renal and urinary disorders
Acute kidney injury
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
0.00%
0/20 • Up to 30 days post-treatment
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/20 • Up to 30 days post-treatment
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
0.00%
0/20 • Up to 30 days post-treatment
|
5.0%
1/20 • Number of events 5 • Up to 30 days post-treatment
|
|
Reproductive system and breast disorders
Vaginal discharge
|
5.0%
1/20 • Number of events 2 • Up to 30 days post-treatment
|
0.00%
0/20 • Up to 30 days post-treatment
|
|
Reproductive system and breast disorders
Vaginal dryness
|
5.0%
1/20 • Number of events 10 • Up to 30 days post-treatment
|
0.00%
0/20 • Up to 30 days post-treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
15.0%
3/20 • Number of events 4 • Up to 30 days post-treatment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/20 • Up to 30 days post-treatment
|
5.0%
1/20 • Number of events 4 • Up to 30 days post-treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
15.0%
3/20 • Number of events 53 • Up to 30 days post-treatment
|
20.0%
4/20 • Number of events 21 • Up to 30 days post-treatment
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/20 • Up to 30 days post-treatment
|
15.0%
3/20 • Number of events 10 • Up to 30 days post-treatment
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/20 • Up to 30 days post-treatment
|
5.0%
1/20 • Number of events 1 • Up to 30 days post-treatment
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
10.0%
2/20 • Number of events 14 • Up to 30 days post-treatment
|
0.00%
0/20 • Up to 30 days post-treatment
|
|
Vascular disorders
Hot flashes
|
0.00%
0/20 • Up to 30 days post-treatment
|
30.0%
6/20 • Number of events 25 • Up to 30 days post-treatment
|
|
Vascular disorders
Hypertension
|
5.0%
1/20 • Number of events 13 • Up to 30 days post-treatment
|
10.0%
2/20 • Number of events 6 • Up to 30 days post-treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place