Trial Outcomes & Findings for ZW25 in Women With Endometrial Cancers (NCT NCT04513665)
NCT ID: NCT04513665
Last Updated: 2025-05-22
Results Overview
ORR = Compete Response (CR) + Partial Response (PR) by RECIST v 1.1 \</= 24 weeks from the start of treatment
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
</= 24 weeks from the start of treatment
Results posted on
2025-05-22
Participant Flow
No participants accrued to Stage 2 arm.
Participant milestones
| Measure |
Stage 1
Participants will have recurrent endometrial carcinoma or carcinosarcoma with HER2 overexpression and 1-2 prior lines of chemotherapy. 16 participants will be accrued. If 2 or greater responses are seen, Stage 2 will accrue additional participants.
ZW25: ZW25 at 20mg/kg intravenously (IV) every two weeks.
|
Stage 2
If 2 or greater responses are seen during Stage 1, Stage 2 will accrue an additional 9 participants. Participants will have recurrent endometrial carcinoma or carcinosarcoma with HER2 overexpression and 1-2 prior lines of chemotherapy.
ZW25: ZW25 at 20mg/kg intravenously (IV) every two weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
16
|
0
|
Reasons for withdrawal
| Measure |
Stage 1
Participants will have recurrent endometrial carcinoma or carcinosarcoma with HER2 overexpression and 1-2 prior lines of chemotherapy. 16 participants will be accrued. If 2 or greater responses are seen, Stage 2 will accrue additional participants.
ZW25: ZW25 at 20mg/kg intravenously (IV) every two weeks.
|
Stage 2
If 2 or greater responses are seen during Stage 1, Stage 2 will accrue an additional 9 participants. Participants will have recurrent endometrial carcinoma or carcinosarcoma with HER2 overexpression and 1-2 prior lines of chemotherapy.
ZW25: ZW25 at 20mg/kg intravenously (IV) every two weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Lack of Efficacy
|
14
|
0
|
Baseline Characteristics
ZW25 in Women With Endometrial Cancers
Baseline characteristics by cohort
| Measure |
Stage 1
n=16 Participants
Participants will have recurrent endometrial carcinoma or carcinosarcoma with HER2 overexpression and 1-2 prior lines of chemotherapy. 16 participants will be accrued. If 2 or greater responses are seen, Stage 2 will accrue additional participants.
ZW25: ZW25 at 20mg/kg intravenously (IV) every two weeks.
|
Stage 2
If 2 or greater responses are seen during Stage 1, Stage 2 will accrue an additional 9 participants. Participants will have recurrent endometrial carcinoma or carcinosarcoma with HER2 overexpression and 1-2 prior lines of chemotherapy.
ZW25: ZW25 at 20mg/kg intravenously (IV) every two weeks.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71 years
n=93 Participants
|
—
|
71 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=93 Participants
|
—
|
16 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=93 Participants
|
—
|
16 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
—
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=93 Participants
|
—
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=93 Participants
|
—
|
10 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=93 Participants
|
—
|
16 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: </= 24 weeks from the start of treatmentPopulation: No participants accrued to Stage 2 arm
ORR = Compete Response (CR) + Partial Response (PR) by RECIST v 1.1 \</= 24 weeks from the start of treatment
Outcome measures
| Measure |
Stage 1
n=16 Participants
Participants will have recurrent endometrial carcinoma or carcinosarcoma with HER2 overexpression and 1-2 prior lines of chemotherapy. 16 participants will be accrued. If 2 or greater responses are seen, Stage 2 will accrue additional participants.
ZW25: ZW25 at 20mg/kg intravenously (IV) every two weeks.
|
Stage 2
If 2 or greater responses are seen during Stage 1, Stage 2 will accrue an additional 9 participants. Participants will have recurrent endometrial carcinoma or carcinosarcoma with HER2 overexpression and 1-2 prior lines of chemotherapy.
ZW25: ZW25 at 20mg/kg intravenously (IV) every two weeks.
|
|---|---|---|
|
Overall Response Rate/ORR of Participants
Participants with ORR (CR + PR)
|
1 Participants
|
—
|
|
Overall Response Rate/ORR of Participants
Participants without ORR (CR + PR)
|
15 Participants
|
—
|
Adverse Events
Stage 1
Serious events: 2 serious events
Other events: 16 other events
Deaths: 8 deaths
Stage 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stage 1
n=16 participants at risk
Participants will have recurrent endometrial carcinoma or carcinosarcoma with HER2 overexpression and 1-2 prior lines of chemotherapy. 16 participants will be accrued. If 2 or greater responses are seen, Stage 2 will accrue additional participants.
ZW25: ZW25 at 20mg/kg intravenously (IV) every two weeks.
|
Stage 2
If 2 or greater responses are seen during Stage 1, Stage 2 will accrue an additional 9 participants. Participants will have recurrent endometrial carcinoma or carcinosarcoma with HER2 overexpression and 1-2 prior lines of chemotherapy.
ZW25: ZW25 at 20mg/kg intravenously (IV) every two weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
12.5%
2/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
Other adverse events
| Measure |
Stage 1
n=16 participants at risk
Participants will have recurrent endometrial carcinoma or carcinosarcoma with HER2 overexpression and 1-2 prior lines of chemotherapy. 16 participants will be accrued. If 2 or greater responses are seen, Stage 2 will accrue additional participants.
ZW25: ZW25 at 20mg/kg intravenously (IV) every two weeks.
|
Stage 2
If 2 or greater responses are seen during Stage 1, Stage 2 will accrue an additional 9 participants. Participants will have recurrent endometrial carcinoma or carcinosarcoma with HER2 overexpression and 1-2 prior lines of chemotherapy.
ZW25: ZW25 at 20mg/kg intravenously (IV) every two weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
6.2%
1/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
2/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Immune system disorders
Allergic reaction
|
6.2%
1/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.2%
1/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Blood and lymphatic system disorders
Anemia
|
6.2%
1/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Metabolism and nutrition disorders
Anorexia
|
43.8%
7/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Gastrointestinal disorders
Ascites
|
12.5%
2/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
1/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Eye disorders
Blurred vision
|
6.2%
1/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Infections and infestations
Catheter related infection
|
6.2%
1/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Gastrointestinal disorders
Colonic obstruction
|
6.2%
1/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Gastrointestinal disorders
Constipation
|
12.5%
2/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
2/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Gastrointestinal disorders
Diarrhea
|
75.0%
12/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Eye disorders
Dry eye
|
6.2%
1/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Gastrointestinal disorders
Dry mouth
|
6.2%
1/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Nervous system disorders
Dysgeusia
|
12.5%
2/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
2/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
18.8%
3/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Renal and urinary disorders
Dysuria
|
6.2%
1/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
General disorders
Edema limbs
|
6.2%
1/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Skin and subcutaneous tissue disorders
Eyebrow hair loss
|
6.2%
1/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Injury, poisoning and procedural complications
Fall
|
18.8%
3/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
General disorders
Fatigue
|
25.0%
4/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
General disorders
Fever
|
12.5%
2/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Eye disorders
Floaters
|
6.2%
1/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.2%
1/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Nervous system disorders
Headache
|
6.2%
1/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Gastrointestinal disorders
Hemorrhoids
|
6.2%
1/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
6.2%
1/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.2%
1/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Vascular disorders
Hypertension
|
12.5%
2/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.2%
1/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
18.8%
3/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Infections and infestations
Laryngitis
|
6.2%
1/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Infections and infestations
Lung infection
|
6.2%
1/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Blood and lymphatic system disorders
Lymph node pain
|
6.2%
1/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
General disorders
Malaise
|
6.2%
1/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Gastrointestinal disorders
Mucositis oral
|
6.2%
1/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
12.5%
2/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
31.2%
5/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
18.8%
3/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Respiratory, thoracic and mediastinal disorders
Nasal mucositis
|
6.2%
1/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Gastrointestinal disorders
Nausea
|
25.0%
4/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
General disorders
Neck edema
|
6.2%
1/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
General disorders
Pain
|
6.2%
1/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
2/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Cardiac disorders
Palpitations
|
12.5%
2/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Infections and infestations
Papulopustular rash
|
6.2%
1/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Nervous system disorders
Paresthesia
|
6.2%
1/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.2%
1/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
1/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
25.0%
4/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
6.2%
1/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Cardiac disorders
Sinus tachycardia
|
6.2%
1/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
6.2%
1/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Vascular disorders
Thromboembolic event
|
6.2%
1/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Infections and infestations
Thrush
|
6.2%
1/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Infections and infestations
Upper respiratory infection
|
6.2%
1/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Infections and infestations
Urinary tract infection
|
6.2%
1/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Renal and urinary disorders
Urinary urgency
|
6.2%
1/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
6.2%
1/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Gastrointestinal disorders
Vomiting
|
18.8%
3/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
|
Investigations
Weight loss
|
18.8%
3/16 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
—
0/0 • 24 weeks from end of treatment, up to 48 weeks
No participants accrued to Stage 2 arm
|
Additional Information
Dr. Vicky Makker, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4224
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place