Trial Outcomes & Findings for A Study of Onapristone ER Alone Or In Combination With Anastrozole in Gynecologic Cancers That Respond to Progesterone (NCT NCT03909152)
NCT ID: NCT03909152
Last Updated: 2025-07-28
Results Overview
as determined by RECIST 1.1 response. 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) = Complete Response + Partial Response (CR + PR)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
within 36 weeks
Results posted on
2025-07-28
Participant Flow
Participant milestones
| Measure |
PR+ Granulosa Cell Tumor (This Arm is CLOSED)
Enrolled patients will initiate treatment with onapristone ER 50 mg by mouth twice daily, about 12 hours apart, beginning Day 1 of Cycle 1. A Cycle is 28 days. This Arm is CLOSED.
Onapristone ER: 50 mg PO BID (with dosage adjustments) until POD, unacceptable toxicity or withdrawal of consent.
|
PR+ Low Grade Serous Ovarian Cancer
Enrolled patients will initiate treatment with onapristone ER 50 mg by mouth twice daily, about 12 hours apart, beginning Day 1 of Cycle 1. A Cycle is 28 days
Onapristone ER: 50 mg PO BID (with dosage adjustments) until POD, unacceptable toxicity or withdrawal of consent.
|
PR+ Endometrioid Endometrial Cancer
Enrolled patients will initiate treatment with onapristone ER 50 mg by mouth twice daily, about 12 hours apart, beginning Day 1 of Cycle 1. A Cycle is 28 days
Onapristone ER: 50 mg PO BID (with dosage adjustments) until POD, unacceptable toxicity or withdrawal of consent.
|
PR+ Granulosa Cell Ovarian Cancer
Enrolled patients will initiate treatment with onapristone ER 50 mg by mouth twice daily, about 12 hours apart and anastrozole 1mg po QD in AM beginning Day 1 of Cycle 1. A Cycle is 28 days.
Onapristone ER + Anastrozole: Onapristone ER Patients will take 50 PO BID in the form of two 20 mg tablets and one 10 mg tablet taken with food and water twice daily. Patients will be prescribed anastrozole 1mg PO QD. Anastrozole will be taken once daily in the AM with patients morning dose of onapristone ER.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
5
|
1
|
14
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
14
|
5
|
1
|
14
|
Reasons for withdrawal
| Measure |
PR+ Granulosa Cell Tumor (This Arm is CLOSED)
Enrolled patients will initiate treatment with onapristone ER 50 mg by mouth twice daily, about 12 hours apart, beginning Day 1 of Cycle 1. A Cycle is 28 days. This Arm is CLOSED.
Onapristone ER: 50 mg PO BID (with dosage adjustments) until POD, unacceptable toxicity or withdrawal of consent.
|
PR+ Low Grade Serous Ovarian Cancer
Enrolled patients will initiate treatment with onapristone ER 50 mg by mouth twice daily, about 12 hours apart, beginning Day 1 of Cycle 1. A Cycle is 28 days
Onapristone ER: 50 mg PO BID (with dosage adjustments) until POD, unacceptable toxicity or withdrawal of consent.
|
PR+ Endometrioid Endometrial Cancer
Enrolled patients will initiate treatment with onapristone ER 50 mg by mouth twice daily, about 12 hours apart, beginning Day 1 of Cycle 1. A Cycle is 28 days
Onapristone ER: 50 mg PO BID (with dosage adjustments) until POD, unacceptable toxicity or withdrawal of consent.
|
PR+ Granulosa Cell Ovarian Cancer
Enrolled patients will initiate treatment with onapristone ER 50 mg by mouth twice daily, about 12 hours apart and anastrozole 1mg po QD in AM beginning Day 1 of Cycle 1. A Cycle is 28 days.
Onapristone ER + Anastrozole: Onapristone ER Patients will take 50 PO BID in the form of two 20 mg tablets and one 10 mg tablet taken with food and water twice daily. Patients will be prescribed anastrozole 1mg PO QD. Anastrozole will be taken once daily in the AM with patients morning dose of onapristone ER.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
14
|
5
|
1
|
14
|
Baseline Characteristics
A Study of Onapristone ER Alone Or In Combination With Anastrozole in Gynecologic Cancers That Respond to Progesterone
Baseline characteristics by cohort
| Measure |
PR+ Granulosa Cell Tumor (This Arm is CLOSED)
n=14 Participants
Enrolled patients will initiate treatment with onapristone ER 50 mg by mouth twice daily, about 12 hours apart, beginning Day 1 of Cycle 1. A Cycle is 28 days. This Arm is CLOSED.
Onapristone ER: 50 mg PO BID (with dosage adjustments) until POD, unacceptable toxicity or withdrawal of consent.
|
PR+ Low Grade Serous Ovarian Cancer
n=5 Participants
Enrolled patients will initiate treatment with onapristone ER 50 mg by mouth twice daily, about 12 hours apart, beginning Day 1 of Cycle 1. A Cycle is 28 days
Onapristone ER: 50 mg PO BID (with dosage adjustments) until POD, unacceptable toxicity or withdrawal of consent.
|
PR+ Endometrioid Endometrial Cancer
n=1 Participants
Enrolled patients will initiate treatment with onapristone ER 50 mg by mouth twice daily, about 12 hours apart, beginning Day 1 of Cycle 1. A Cycle is 28 days
Onapristone ER: 50 mg PO BID (with dosage adjustments) until POD, unacceptable toxicity or withdrawal of consent.
|
PR+ Granulosa Cell Ovarian Cancer
n=14 Participants
Enrolled patients will initiate treatment with onapristone ER 50 mg by mouth twice daily, about 12 hours apart and anastrozole 1mg po QD in AM beginning Day 1 of Cycle 1. A Cycle is 28 days.
Onapristone ER + Anastrozole: Onapristone ER Patients will take 50 PO BID in the form of two 20 mg tablets and one 10 mg tablet taken with food and water twice daily. Patients will be prescribed anastrozole 1mg PO QD. Anastrozole will be taken once daily in the AM with patients morning dose of onapristone ER.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
62.5 years
STANDARD_DEVIATION 29 • n=5 Participants
|
59 years
STANDARD_DEVIATION 25 • n=7 Participants
|
65 years
STANDARD_DEVIATION 1 • n=5 Participants
|
58 years
STANDARD_DEVIATION 32 • n=4 Participants
|
60 years
STANDARD_DEVIATION 24 • n=21 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: within 36 weeksas determined by RECIST 1.1 response. 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) = Complete Response + Partial Response (CR + PR)
Outcome measures
| Measure |
PR+ Granulosa Cell Tumor (This Arm is CLOSED)
n=14 Participants
Enrolled patients will initiate treatment with onapristone ER 50 mg by mouth twice daily, about 12 hours apart, beginning Day 1 of Cycle 1. A Cycle is 28 days. This Arm is CLOSED.
Onapristone ER: 50 mg PO BID (with dosage adjustments) until POD, unacceptable toxicity or withdrawal of consent.
|
PR+ Low Grade Serous Ovarian Cancer
n=5 Participants
Enrolled patients will initiate treatment with onapristone ER 50 mg by mouth twice daily, about 12 hours apart, beginning Day 1 of Cycle 1. A Cycle is 28 days
Onapristone ER: 50 mg PO BID (with dosage adjustments) until POD, unacceptable toxicity or withdrawal of consent.
|
PR+ Endometrioid Endometrial Cancer
n=1 Participants
Enrolled patients will initiate treatment with onapristone ER 50 mg by mouth twice daily, about 12 hours apart, beginning Day 1 of Cycle 1. A Cycle is 28 days
Onapristone ER: 50 mg PO BID (with dosage adjustments) until POD, unacceptable toxicity or withdrawal of consent.
|
PR+ Granulosa Cell Ovarian Cancer
n=14 Participants
Enrolled patients will initiate treatment with onapristone ER 50 mg by mouth twice daily, about 12 hours apart and anastrozole 1mg po QD in AM beginning Day 1 of Cycle 1. A Cycle is 28 days.
Onapristone ER + Anastrozole: Onapristone ER Patients will take 50 PO BID in the form of two 20 mg tablets and one 10 mg tablet taken with food and water twice daily. Patients will be prescribed anastrozole 1mg PO QD. Anastrozole will be taken once daily in the AM with patients morning dose of onapristone ER.
|
|---|---|---|---|---|
|
Overall Response Rate
Participants with Overall Response Rate (Complete Response + Partial Response)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Overall Response Rate
Participants with no Overall Response Rate (Complete Response + Partial Response)
|
14 Participants
|
5 Participants
|
1 Participants
|
14 Participants
|
Adverse Events
PR+ Granulosa Cell Tumor (This Arm is CLOSED)
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
PR+ Low Grade Serous Ovarian Cancer
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
PR+ Endometrioid Endometrial Cancer
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
PR+ Granulosa Cell Ovarian Cancer
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PR+ Granulosa Cell Tumor (This Arm is CLOSED)
n=14 participants at risk
Enrolled patients will initiate treatment with onapristone ER 50 mg by mouth twice daily, about 12 hours apart, beginning Day 1 of Cycle 1. A Cycle is 28 days. This Arm is CLOSED.
Onapristone ER: 50 mg PO BID (with dosage adjustments) until POD, unacceptable toxicity or withdrawal of consent.
|
PR+ Low Grade Serous Ovarian Cancer
n=5 participants at risk
Enrolled patients will initiate treatment with onapristone ER 50 mg by mouth twice daily, about 12 hours apart, beginning Day 1 of Cycle 1. A Cycle is 28 days
Onapristone ER: 50 mg PO BID (with dosage adjustments) until POD, unacceptable toxicity or withdrawal of consent.
|
PR+ Endometrioid Endometrial Cancer
n=1 participants at risk
Enrolled patients will initiate treatment with onapristone ER 50 mg by mouth twice daily, about 12 hours apart, beginning Day 1 of Cycle 1. A Cycle is 28 days
Onapristone ER: 50 mg PO BID (with dosage adjustments) until POD, unacceptable toxicity or withdrawal of consent.
|
PR+ Granulosa Cell Ovarian Cancer
n=14 participants at risk
Enrolled patients will initiate treatment with onapristone ER 50 mg by mouth twice daily, about 12 hours apart and anastrozole 1mg po QD in AM beginning Day 1 of Cycle 1. A Cycle is 28 days.
Onapristone ER + Anastrozole: Onapristone ER Patients will take 50 PO BID in the form of two 20 mg tablets and one 10 mg tablet taken with food and water twice daily. Patients will be prescribed anastrozole 1mg PO QD. Anastrozole will be taken once daily in the AM with patients morning dose of onapristone ER.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/14 • Up to 36 weeks
|
40.0%
2/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
0.00%
0/14 • Up to 36 weeks
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/14 • Up to 36 weeks
|
20.0%
1/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
0.00%
0/14 • Up to 36 weeks
|
|
Vascular disorders
Thromboembolic event
|
7.1%
1/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
0.00%
0/14 • Up to 36 weeks
|
|
Nervous system disorders
Syncope
|
7.1%
1/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
0.00%
0/14 • Up to 36 weeks
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.1%
1/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
0.00%
0/14 • Up to 36 weeks
|
|
General disorders
Fatigue
|
0.00%
0/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
7.1%
1/14 • Up to 36 weeks
|
|
Gastrointestinal disorders
Duodenal hemorrhage
|
0.00%
0/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
7.1%
1/14 • Up to 36 weeks
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
7.1%
1/14 • Up to 36 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
7.1%
1/14 • Up to 36 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
7.1%
1/14 • Up to 36 weeks
|
Other adverse events
| Measure |
PR+ Granulosa Cell Tumor (This Arm is CLOSED)
n=14 participants at risk
Enrolled patients will initiate treatment with onapristone ER 50 mg by mouth twice daily, about 12 hours apart, beginning Day 1 of Cycle 1. A Cycle is 28 days. This Arm is CLOSED.
Onapristone ER: 50 mg PO BID (with dosage adjustments) until POD, unacceptable toxicity or withdrawal of consent.
|
PR+ Low Grade Serous Ovarian Cancer
n=5 participants at risk
Enrolled patients will initiate treatment with onapristone ER 50 mg by mouth twice daily, about 12 hours apart, beginning Day 1 of Cycle 1. A Cycle is 28 days
Onapristone ER: 50 mg PO BID (with dosage adjustments) until POD, unacceptable toxicity or withdrawal of consent.
|
PR+ Endometrioid Endometrial Cancer
n=1 participants at risk
Enrolled patients will initiate treatment with onapristone ER 50 mg by mouth twice daily, about 12 hours apart, beginning Day 1 of Cycle 1. A Cycle is 28 days
Onapristone ER: 50 mg PO BID (with dosage adjustments) until POD, unacceptable toxicity or withdrawal of consent.
|
PR+ Granulosa Cell Ovarian Cancer
n=14 participants at risk
Enrolled patients will initiate treatment with onapristone ER 50 mg by mouth twice daily, about 12 hours apart and anastrozole 1mg po QD in AM beginning Day 1 of Cycle 1. A Cycle is 28 days.
Onapristone ER + Anastrozole: Onapristone ER Patients will take 50 PO BID in the form of two 20 mg tablets and one 10 mg tablet taken with food and water twice daily. Patients will be prescribed anastrozole 1mg PO QD. Anastrozole will be taken once daily in the AM with patients morning dose of onapristone ER.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
7.1%
1/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
0.00%
0/14 • Up to 36 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
28.6%
4/14 • Up to 36 weeks
|
20.0%
1/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
21.4%
3/14 • Up to 36 weeks
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
7.1%
1/14 • Up to 36 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
14.3%
2/14 • Up to 36 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
28.6%
4/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
21.4%
3/14 • Up to 36 weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
7.1%
1/14 • Up to 36 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
1/14 • Up to 36 weeks
|
20.0%
1/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
14.3%
2/14 • Up to 36 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
7.1%
1/14 • Up to 36 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
1/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
14.3%
2/14 • Up to 36 weeks
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
100.0%
1/1 • Up to 36 weeks
|
0.00%
0/14 • Up to 36 weeks
|
|
Reproductive system and breast disorders
Breast edema
|
7.1%
1/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
0.00%
0/14 • Up to 36 weeks
|
|
Reproductive system and breast disorders
Breast pain
|
7.1%
1/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
7.1%
1/14 • Up to 36 weeks
|
|
General disorders
Chills
|
7.1%
1/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
7.1%
1/14 • Up to 36 weeks
|
|
Psychiatric disorders
Confusion
|
0.00%
0/14 • Up to 36 weeks
|
20.0%
1/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
0.00%
0/14 • Up to 36 weeks
|
|
General disorders
Constipation
|
21.4%
3/14 • Up to 36 weeks
|
20.0%
1/5 • Up to 36 weeks
|
100.0%
1/1 • Up to 36 weeks
|
28.6%
4/14 • Up to 36 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.4%
3/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
0.00%
0/14 • Up to 36 weeks
|
|
Psychiatric disorders
Delirium
|
0.00%
0/14 • Up to 36 weeks
|
20.0%
1/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
0.00%
0/14 • Up to 36 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
2/14 • Up to 36 weeks
|
20.0%
1/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
14.3%
2/14 • Up to 36 weeks
|
|
Nervous system disorders
Dizziness
|
28.6%
4/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
7.1%
1/14 • Up to 36 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
7.1%
1/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
14.3%
2/14 • Up to 36 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
14.3%
2/14 • Up to 36 weeks
|
|
Gastrointestinal disorders
Duodenal hemorrhage
|
0.00%
0/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
7.1%
1/14 • Up to 36 weeks
|
|
Nervous system disorders
Dysgeusia
|
7.1%
1/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
0.00%
0/14 • Up to 36 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
14.3%
2/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
0.00%
0/14 • Up to 36 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/14 • Up to 36 weeks
|
20.0%
1/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
7.1%
1/14 • Up to 36 weeks
|
|
General disorders
Edema limbs
|
14.3%
2/14 • Up to 36 weeks
|
20.0%
1/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
7.1%
1/14 • Up to 36 weeks
|
|
General disorders
Fatigue
|
35.7%
5/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
42.9%
6/14 • Up to 36 weeks
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.1%
1/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
0.00%
0/14 • Up to 36 weeks
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/14 • Up to 36 weeks
|
20.0%
1/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
7.1%
1/14 • Up to 36 weeks
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/14 • Up to 36 weeks
|
20.0%
1/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
0.00%
0/14 • Up to 36 weeks
|
|
Nervous system disorders
Headache
|
7.1%
1/14 • Up to 36 weeks
|
20.0%
1/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
28.6%
4/14 • Up to 36 weeks
|
|
Ear and labyrinth disorders
Hearing impaired
|
7.1%
1/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
0.00%
0/14 • Up to 36 weeks
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
100.0%
1/1 • Up to 36 weeks
|
0.00%
0/14 • Up to 36 weeks
|
|
Vascular disorders
Hot flashes
|
7.1%
1/14 • Up to 36 weeks
|
40.0%
2/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
21.4%
3/14 • Up to 36 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
7.1%
1/14 • Up to 36 weeks
|
|
Psychiatric disorders
Insomnia
|
7.1%
1/14 • Up to 36 weeks
|
20.0%
1/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
7.1%
1/14 • Up to 36 weeks
|
|
General disorders
Localized edema
|
7.1%
1/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
7.1%
1/14 • Up to 36 weeks
|
|
Blood and lymphatic system disorders
Lymph node pain
|
7.1%
1/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
0.00%
0/14 • Up to 36 weeks
|
|
General disorders
Malaise
|
0.00%
0/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
7.1%
1/14 • Up to 36 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
7.1%
1/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
0.00%
0/14 • Up to 36 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.1%
1/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
7.1%
1/14 • Up to 36 weeks
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
7.1%
1/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
0.00%
0/14 • Up to 36 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
7.1%
1/14 • Up to 36 weeks
|
|
Gastrointestinal disorders
Nausea
|
42.9%
6/14 • Up to 36 weeks
|
40.0%
2/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
0.00%
0/14 • Up to 36 weeks
|
|
General disorders
Neck edema
|
7.1%
1/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
0.00%
0/14 • Up to 36 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
7.1%
1/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
0.00%
0/14 • Up to 36 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
28.6%
4/14 • Up to 36 weeks
|
20.0%
1/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
7.1%
1/14 • Up to 36 weeks
|
|
Nervous system disorders
Paresthesia
|
7.1%
1/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
0.00%
0/14 • Up to 36 weeks
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
7.1%
1/14 • Up to 36 weeks
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/14 • Up to 36 weeks
|
20.0%
1/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
0.00%
0/14 • Up to 36 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
7.1%
1/14 • Up to 36 weeks
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.1%
1/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
7.1%
1/14 • Up to 36 weeks
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
7.1%
1/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
0.00%
0/14 • Up to 36 weeks
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
100.0%
1/1 • Up to 36 weeks
|
0.00%
0/14 • Up to 36 weeks
|
|
Infections and infestations
Skin infection
|
7.1%
1/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
7.1%
1/14 • Up to 36 weeks
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/14 • Up to 36 weeks
|
20.0%
1/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
0.00%
0/14 • Up to 36 weeks
|
|
Nervous system disorders
Syncope
|
7.1%
1/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
0.00%
0/14 • Up to 36 weeks
|
|
Vascular disorders
Thromboembolic event
|
7.1%
1/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
0.00%
0/14 • Up to 36 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/14 • Up to 36 weeks
|
20.0%
1/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
0.00%
0/14 • Up to 36 weeks
|
|
Infections and infestations
Upper respiratory infection
|
14.3%
2/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
28.6%
4/14 • Up to 36 weeks
|
|
Renal and urinary disorders
Urinary incontinence
|
7.1%
1/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
0.00%
0/14 • Up to 36 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/14 • Up to 36 weeks
|
20.0%
1/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
0.00%
0/14 • Up to 36 weeks
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
7.1%
1/14 • Up to 36 weeks
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
7.1%
1/14 • Up to 36 weeks
|
|
Infections and infestations
Vaginal infection
|
7.1%
1/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
0.00%
0/14 • Up to 36 weeks
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
4/14 • Up to 36 weeks
|
20.0%
1/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
7.1%
1/14 • Up to 36 weeks
|
|
Investigations
Weight loss
|
21.4%
3/14 • Up to 36 weeks
|
0.00%
0/5 • Up to 36 weeks
|
0.00%
0/1 • Up to 36 weeks
|
7.1%
1/14 • Up to 36 weeks
|
Additional Information
Dr. Rachel Grisham, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4653
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place