Trial Outcomes & Findings for Phase 1/2 Trial of Selinexor (KPT-330) With Docetaxel for Non-small Cell Lung Cancer (NSCLC) (NCT NCT03095612)
NCT ID: NCT03095612
Last Updated: 2024-06-13
Results Overview
A DLT was any Grade 3 or 4 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0). DLTs were collected to determine the Maximum-Tolerated Dose (MTD). \*\*DLT will include the following when considered to be at least possibly related to study drug administration: 1) \> 1 missed doses (out of 4 doses) of study treatment during cycle 1 due to study treatment related toxicities 2) Discontinuation of study therapy before completion of Cycle 1, due to study-drug related toxicity.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
41 participants
Primary outcome timeframe
Each 21 day cycle for 2 years
Results posted on
2024-06-13
Participant Flow
41 subjects consented;1 screen failed prior to receiving treatment. Participants started at dosing selinexor 60 mg + docetaxel 75 mg/m2. The second dose level was 80 mg +docetaxel 75 mg/m2 to which 4 subjects were assigned. Then 33 patients enrolled and started on Dose expansion: selinexor 60 mg weekly plus docetaxel 75 mg/m2 3 weekly. No data was collected or analyzed for the selinexor Monotherapy cohort, study was halted due to funding.
Participant milestones
| Measure |
Dose Escalation Phase: Selinexor 60 mg and in Combination With Docetaxel
'3x3' Dose escalation (cycle = 21 days). Selinexor once weekly oral administration (cohorts 60mg, 80mg, 100mg…) Docetaxel once every 3 weeks (75mg/m2 IV).
cohort escalation until MTD (maximum tolerated dose) is established.
|
Dose Escalation Phase: Selinexor 80 mg and in Combination With Docetaxel
'3x3' Dose escalation (cycle = 21 days). Selinexor once weekly oral administration (cohorts 60mg, 80mg, 100mg…) Docetaxel once every 3 weeks (75mg/m2 IV).
cohort escalation until MTD (maximum tolerated dose) is established.
|
Dose Escalation Phase: Selinexor 100 mg and in Combination With Docetaxel
'3x3' Dose escalation (cycle = 21 days). Selinexor once weekly oral administration (cohorts 60mg, 80mg, 100mg…) Docetaxel once every 3 weeks (75mg/m2 IV).
cohort escalation until MTD (maximum tolerated dose) is established.
|
Dose Expansion Phase: Selinexor 60 mg and in Combination With Docetaxel
Selinexor once weekly oral administration Docetaxel once every 3 weeks (75 mg/m2 IV)
|
Selinexor 40 mg Monotherapy
Selinexor once weekly oral (40mg, 60mg, 80mg)
OR
Selinexor twice weekly oral (40mg, 60mg, 80mg)
|
Selinexor 60 mg Monotherapy
Selinexor once weekly oral (40mg, 60mg, 80mg)
OR
Selinexor twice weekly oral (40mg, 60mg, 80mg)
|
Selinexor 80 mg Monotherapy
Selinexor once weekly oral (40mg, 60mg, 80mg)
OR
Selinexor twice weekly oral (40mg, 60mg, 80mg)
|
|---|---|---|---|---|---|---|---|
|
Dose Escalation:Selinexor 60mg+Docetaxel
STARTED
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation:Selinexor 60mg+Docetaxel
COMPLETED
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation:Selinexor 60mg+Docetaxel
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation:Selinexor 80mg+Docetaxel
STARTED
|
0
|
4
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation:Selinexor 80mg+Docetaxel
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation:Selinexor 80mg+Docetaxel
NOT COMPLETED
|
0
|
4
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation:Selinexor100mg+Docetaxel
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation:Selinexor100mg+Docetaxel
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation:Selinexor100mg+Docetaxel
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Expansion:Selinexor 60 mg+Docetaxel
STARTED
|
0
|
0
|
0
|
33
|
0
|
0
|
0
|
|
Dose Expansion:Selinexor 60 mg+Docetaxel
COMPLETED
|
0
|
0
|
0
|
33
|
0
|
0
|
0
|
|
Dose Expansion:Selinexor 60 mg+Docetaxel
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Selinexor 40 mg Monotherapy
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Selinexor 40 mg Monotherapy
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Selinexor 40 mg Monotherapy
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Selinexor 60 mg Monotherapy
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Selinexor 60 mg Monotherapy
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Selinexor 60 mg Monotherapy
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Selinexor 80 mg Monotherapy
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Selinexor 80 mg Monotherapy
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Selinexor 80 mg Monotherapy
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Dose Escalation Phase: Selinexor 60 mg and in Combination With Docetaxel
'3x3' Dose escalation (cycle = 21 days). Selinexor once weekly oral administration (cohorts 60mg, 80mg, 100mg…) Docetaxel once every 3 weeks (75mg/m2 IV).
cohort escalation until MTD (maximum tolerated dose) is established.
|
Dose Escalation Phase: Selinexor 80 mg and in Combination With Docetaxel
'3x3' Dose escalation (cycle = 21 days). Selinexor once weekly oral administration (cohorts 60mg, 80mg, 100mg…) Docetaxel once every 3 weeks (75mg/m2 IV).
cohort escalation until MTD (maximum tolerated dose) is established.
|
Dose Escalation Phase: Selinexor 100 mg and in Combination With Docetaxel
'3x3' Dose escalation (cycle = 21 days). Selinexor once weekly oral administration (cohorts 60mg, 80mg, 100mg…) Docetaxel once every 3 weeks (75mg/m2 IV).
cohort escalation until MTD (maximum tolerated dose) is established.
|
Dose Expansion Phase: Selinexor 60 mg and in Combination With Docetaxel
Selinexor once weekly oral administration Docetaxel once every 3 weeks (75 mg/m2 IV)
|
Selinexor 40 mg Monotherapy
Selinexor once weekly oral (40mg, 60mg, 80mg)
OR
Selinexor twice weekly oral (40mg, 60mg, 80mg)
|
Selinexor 60 mg Monotherapy
Selinexor once weekly oral (40mg, 60mg, 80mg)
OR
Selinexor twice weekly oral (40mg, 60mg, 80mg)
|
Selinexor 80 mg Monotherapy
Selinexor once weekly oral (40mg, 60mg, 80mg)
OR
Selinexor twice weekly oral (40mg, 60mg, 80mg)
|
|---|---|---|---|---|---|---|---|
|
Dose Escalation:Selinexor 80mg+Docetaxel
Dose not tolerated by the subject
|
0
|
4
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Phase 1/2 Trial of Selinexor (KPT-330) With Docetaxel for Non-small Cell Lung Cancer (NSCLC)
Baseline characteristics by cohort
| Measure |
Dose Escalation: Selinexor 60 mg + Docetaxel
n=3 Participants
Dose Escalation Phase: Selinexor 60 mg and in Combination With Docetaxel '3x3' Dose escalation (cycle = 21 days). Selinexor once weekly oral administration (cohorts 60mg, 80mg) Docetaxel once every 3 weeks (75mg/m2 IV).
cohort escalation until MTD (maximum tolerated dose) is established.
|
Dose Escalation: Selinexor 80 mg + Docetaxel
n=4 Participants
Dose Escalation Phase: Selinexor 800 mg and in Combination With Docetaxel '3x3' Dose escalation (cycle = 21 days). Selinexor once weekly oral administration (cohorts 60mg, 80mg) Docetaxel once every 3 weeks (75mg/m2 IV).
cohort escalation until MTD (maximum tolerated dose) is established.
|
Dose Expansion Phase: Selinexor 60 + Docetaxel
n=33 Participants
Dose Expansion Phase: Selinexor 60 mg and in Combination With Docetaxel Selinexor once weekly oral administration Docetaxel once every 3 weeks (75 mg/m2 IV)
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
33 Participants
n=4 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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
33 participants
n=5 Participants
|
40 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Each 21 day cycle for 2 yearsPopulation: The study was halted prior to participants receiving selinexor monotherapy. No data was collected or analyzed for the selinexor Monotherapy Cohort.
A DLT was any Grade 3 or 4 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0). DLTs were collected to determine the Maximum-Tolerated Dose (MTD). \*\*DLT will include the following when considered to be at least possibly related to study drug administration: 1) \> 1 missed doses (out of 4 doses) of study treatment during cycle 1 due to study treatment related toxicities 2) Discontinuation of study therapy before completion of Cycle 1, due to study-drug related toxicity.
Outcome measures
| Measure |
Selinexor in Combination With Docetaxel Cohort
n=40 Participants
Selinexor will be administered once weekly starting one week before chemotherapy initiation in combination with docetaxel. Docetaxel will be given once every 3 weeks. Treatment will be administered in 21-day cycles. Selinexor dose escalation: 60, 80, 40 mg once weekly. Docetaxel 75 mg/m2 IV, 60 every 3 weeks.
Selinexor: Selinexor once weekly oral or twice weekly oral
Docetaxel: Docetaxel once every 3 weeks (75 mg/m2 IV)
|
Selinexor Monotherapy Cohort
For the selinexor monotherapy cohort, 6 patients each will be treated in two dosing cohorts (weekly and biweekly). Selinexor once weekly oral (40mg, 60mg, 80mg) OR Selinexor twice weekly oral (60mg, 40mg, 60mg weekly).
|
Selinexor 100 mg and in Combination With Docetaxel
'3x3' Dose escalation (cycle = 21 days). Selinexor once weekly oral administration (cohorts 60mg, 80mg, 100mg…) Docetaxel once every 3 weeks (75mg/m2 IV).
cohort escalation until MTD (maximum tolerated dose) is established.
|
Selinexor 40 mg Monotherapy
Selinexor once weekly oral (40mg, 60mg, 80mg)
OR
Selinexor twice weekly oral (40mg, 60mg, 80mg)
|
Selinexor 60 mg Monotherapy
Selinexor once weekly oral (40mg, 60mg, 80mg)
OR
Selinexor twice weekly oral (40mg, 60mg, 80mg)
|
Selinexor 80 mg Monotherapy
Selinexor once weekly oral (40mg, 60mg, 80mg)
OR
Selinexor twice weekly oral (40mg, 60mg, 80mg)
|
|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLT)
selinexor, 80 mg
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Dose Limiting Toxicities (DLT)
selinexor, 60 mg
|
37 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Each 21 day cycle for 2 yearsPopulation: 32 patients were evaluable for disease. This was a 3+3 dose escalation study, participants started at dosing selinexor 60 mg + docetaxel 75 mg/m2. Dose tolerated for 3 patients. 2nd dose level of 80 mg +docetaxel 75 mg/m2 was not tolerated and data was not collected. The remainder of the patients enrolled were then started on selinexor 60 mg weekly plus docetaxel 75 mg/m2 3 weekly. No data was collected or analyzed for the selinexor Monotherapy cohort, study was halted due to funding.
To evaluate the efficacy of selinexor monotherapy and in combination with docetaxel in patients with advanced KRAS mutant NSCLC. Tumor size will be assessed at baseline and every 2 cycles (ie, after 7 weeks for first 2 cycles, and then every 6 weeks) during the treatment period using the Response Evaluation Criteria in Solid Tumors RECIST v1.1 criterion.
Outcome measures
| Measure |
Selinexor in Combination With Docetaxel Cohort
n=32 Participants
Selinexor will be administered once weekly starting one week before chemotherapy initiation in combination with docetaxel. Docetaxel will be given once every 3 weeks. Treatment will be administered in 21-day cycles. Selinexor dose escalation: 60, 80, 40 mg once weekly. Docetaxel 75 mg/m2 IV, 60 every 3 weeks.
Selinexor: Selinexor once weekly oral or twice weekly oral
Docetaxel: Docetaxel once every 3 weeks (75 mg/m2 IV)
|
Selinexor Monotherapy Cohort
For the selinexor monotherapy cohort, 6 patients each will be treated in two dosing cohorts (weekly and biweekly). Selinexor once weekly oral (40mg, 60mg, 80mg) OR Selinexor twice weekly oral (60mg, 40mg, 60mg weekly).
|
Selinexor 100 mg and in Combination With Docetaxel
'3x3' Dose escalation (cycle = 21 days). Selinexor once weekly oral administration (cohorts 60mg, 80mg, 100mg…) Docetaxel once every 3 weeks (75mg/m2 IV).
cohort escalation until MTD (maximum tolerated dose) is established.
|
Selinexor 40 mg Monotherapy
Selinexor once weekly oral (40mg, 60mg, 80mg)
OR
Selinexor twice weekly oral (40mg, 60mg, 80mg)
|
Selinexor 60 mg Monotherapy
Selinexor once weekly oral (40mg, 60mg, 80mg)
OR
Selinexor twice weekly oral (40mg, 60mg, 80mg)
|
Selinexor 80 mg Monotherapy
Selinexor once weekly oral (40mg, 60mg, 80mg)
OR
Selinexor twice weekly oral (40mg, 60mg, 80mg)
|
|---|---|---|---|---|---|---|
|
Tumor Size Will be Assessed Using the RECIST v1.1
|
25 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Dose Escalation: Selinexor 60mg + Docetaxel 75mg/m2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Escalation: Selinexor 80mg + Docetaxel 75mg/m2
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
Dose Escalation:Selinexor 100mg + Docetaxel 75mg/m2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dose Expansion: Selinexor 60 mg + Docetaxel 75mg/m2
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Selinexor 40mg Monotherapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Selinexor 60mg Monotherapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Selinexor 80mg Monotherapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Escalation: Selinexor 60mg + Docetaxel 75mg/m2
n=3 participants at risk
Selinexor will be administered once weekly starting one week before chemotherapy initiation in combination with docetaxel. Docetaxel will be given once every 3 weeks. Treatment will be administered in 21-day cycles. Selinexor dose escalation: 60, 80, 100 mg once weekly. Docetaxel 75 mg/m2 IV, 60 every 3 weeks.
Selinexor: Selinexor once weekly oral or twice weekly oral
Docetaxel: Docetaxel once every 3 weeks (75 mg/m2 IV)
|
Dose Escalation: Selinexor 80mg + Docetaxel 75mg/m2
n=4 participants at risk
Selinexor will be administered once weekly starting one week before chemotherapy initiation in combination with docetaxel. Docetaxel will be given once every 3 weeks. Treatment will be administered in 21-day cycles. Selinexor dose escalation: 60, 80, 100 mg once weekly. Docetaxel 75 mg/m2 IV, 60 every 3 weeks.
Selinexor: Selinexor once weekly oral or twice weekly oral
Docetaxel: Docetaxel once every 3 weeks (75 mg/m2 IV)
|
Dose Escalation:Selinexor 100mg + Docetaxel 75mg/m2
Selinexor will be administered once weekly starting one week before chemotherapy initiation in combination with docetaxel. Docetaxel will be given once every 3 weeks. Treatment will be administered in 21-day cycles. Selinexor dose escalation: 60, 80, 100 mg once weekly. Docetaxel 75 mg/m2 IV, 60 every 3 weeks.
Selinexor: Selinexor once weekly oral or twice weekly oral
Docetaxel: Docetaxel once every 3 weeks (75 mg/m2 IV)
|
Dose Expansion: Selinexor 60 mg + Docetaxel 75mg/m2
n=33 participants at risk
Selinexor dose escalation: 60mg once weekly. Docetaxel 75 mg/m2 IV, 60 every 3 weeks.
|
Selinexor 40mg Monotherapy
For the selinexor monotherapy cohort, 6 patients each will be treated in two dosing cohorts (weekly and biweekly). Selinexor once weekly oral (40mg, 60mg, 80mg) OR Selinexor twice weekly oral (60mg, 40mg, 60mg weekly).
|
Selinexor 60mg Monotherapy
For the selinexor monotherapy cohort, 6 patients each will be treated in two dosing cohorts (weekly and biweekly). Selinexor once weekly oral (40mg, 60mg, 80mg) OR Selinexor twice weekly oral (60mg, 40mg, 60mg weekly).
|
Selinexor 80mg Monotherapy
For the selinexor monotherapy cohort, 6 patients each will be treated in two dosing cohorts (weekly and biweekly). Selinexor once weekly oral (40mg, 60mg, 80mg) OR Selinexor twice weekly oral (60mg, 40mg, 60mg weekly).
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/3 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
0.00%
0/33 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
0.00%
0/33 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Blood and lymphatic system disorders
Hypotension
|
0.00%
0/3 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
0.00%
0/33 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
0.00%
0/33 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
50.0%
2/4 • Number of events 2 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
0.00%
0/33 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
0.00%
0/33 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
25.0%
1/4 • Number of events 2 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
0.00%
0/33 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
50.0%
2/4 • Number of events 3 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
0.00%
0/33 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
General disorders
Head Laceration
|
0.00%
0/3 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
0.00%
0/33 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
0.00%
0/33 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Blood and lymphatic system disorders
Platelets Decreased
|
0.00%
0/3 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
75.0%
3/4 • Number of events 5 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
0.00%
0/33 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
General disorders
Seizure
|
0.00%
0/3 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
0.00%
0/33 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Blood and lymphatic system disorders
Hyperkalemia
|
0.00%
0/3 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
0.00%
0/33 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
General disorders
hypoxia
|
0.00%
0/3 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
0.00%
0/33 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
Other adverse events
| Measure |
Dose Escalation: Selinexor 60mg + Docetaxel 75mg/m2
n=3 participants at risk
Selinexor will be administered once weekly starting one week before chemotherapy initiation in combination with docetaxel. Docetaxel will be given once every 3 weeks. Treatment will be administered in 21-day cycles. Selinexor dose escalation: 60, 80, 100 mg once weekly. Docetaxel 75 mg/m2 IV, 60 every 3 weeks.
Selinexor: Selinexor once weekly oral or twice weekly oral
Docetaxel: Docetaxel once every 3 weeks (75 mg/m2 IV)
|
Dose Escalation: Selinexor 80mg + Docetaxel 75mg/m2
n=4 participants at risk
Selinexor will be administered once weekly starting one week before chemotherapy initiation in combination with docetaxel. Docetaxel will be given once every 3 weeks. Treatment will be administered in 21-day cycles. Selinexor dose escalation: 60, 80, 100 mg once weekly. Docetaxel 75 mg/m2 IV, 60 every 3 weeks.
Selinexor: Selinexor once weekly oral or twice weekly oral
Docetaxel: Docetaxel once every 3 weeks (75 mg/m2 IV)
|
Dose Escalation:Selinexor 100mg + Docetaxel 75mg/m2
Selinexor will be administered once weekly starting one week before chemotherapy initiation in combination with docetaxel. Docetaxel will be given once every 3 weeks. Treatment will be administered in 21-day cycles. Selinexor dose escalation: 60, 80, 100 mg once weekly. Docetaxel 75 mg/m2 IV, 60 every 3 weeks.
Selinexor: Selinexor once weekly oral or twice weekly oral
Docetaxel: Docetaxel once every 3 weeks (75 mg/m2 IV)
|
Dose Expansion: Selinexor 60 mg + Docetaxel 75mg/m2
n=33 participants at risk
Selinexor dose escalation: 60mg once weekly. Docetaxel 75 mg/m2 IV, 60 every 3 weeks.
|
Selinexor 40mg Monotherapy
For the selinexor monotherapy cohort, 6 patients each will be treated in two dosing cohorts (weekly and biweekly). Selinexor once weekly oral (40mg, 60mg, 80mg) OR Selinexor twice weekly oral (60mg, 40mg, 60mg weekly).
|
Selinexor 60mg Monotherapy
For the selinexor monotherapy cohort, 6 patients each will be treated in two dosing cohorts (weekly and biweekly). Selinexor once weekly oral (40mg, 60mg, 80mg) OR Selinexor twice weekly oral (60mg, 40mg, 60mg weekly).
|
Selinexor 80mg Monotherapy
For the selinexor monotherapy cohort, 6 patients each will be treated in two dosing cohorts (weekly and biweekly). Selinexor once weekly oral (40mg, 60mg, 80mg) OR Selinexor twice weekly oral (60mg, 40mg, 60mg weekly).
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
33.3%
1/3 • Number of events 2 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
0.00%
0/4 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
15.2%
5/33 • Number of events 8 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
3/3 • Number of events 8 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
63.6%
21/33 • Number of events 44 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 6 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
50.0%
2/4 • Number of events 8 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
69.7%
23/33 • Number of events 47 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
2/3 • Number of events 3 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
0.00%
0/4 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
57.6%
19/33 • Number of events 24 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
3/3 • Number of events 9 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
33.3%
11/33 • Number of events 11 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Metabolism and nutrition disorders
Anorexia
|
66.7%
2/3 • Number of events 4 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
39.4%
13/33 • Number of events 13 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
3/3 • Number of events 9 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
75.0%
3/4 • Number of events 11 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
33.3%
11/33 • Number of events 20 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Blood and lymphatic system disorders
Neutropenia
|
66.7%
2/3 • Number of events 4 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
0.00%
0/4 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
39.4%
13/33 • Number of events 13 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Investigations
Lymphocytes Decreased/Lymphopenia/Leukopenia
|
100.0%
3/3 • Number of events 16 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
75.0%
3/4 • Number of events 11 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
21.2%
7/33 • Number of events 16 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
50.0%
2/4 • Number of events 6 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
24.2%
8/33 • Number of events 16 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
General disorders
Edema
|
0.00%
0/3 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
0.00%
0/4 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
15.2%
5/33 • Number of events 12 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
0.00%
0/4 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
30.3%
10/33 • Number of events 12 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
0.00%
0/4 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
30.3%
10/33 • Number of events 12 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
66.7%
2/3 • Number of events 2 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
100.0%
4/4 • Number of events 4 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
12.1%
4/33 • Number of events 8 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Investigations
Platelet Counts Decreased
|
33.3%
1/3 • Number of events 2 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
25.0%
1/4 • Number of events 3 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
6.1%
2/33 • Number of events 6 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Investigations
Weight loss
|
33.3%
1/3 • Number of events 4 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
24.2%
8/33 • Number of events 9 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Nervous system disorders
Neuropathy
|
33.3%
1/3 • Number of events 2 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
0.00%
0/4 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
12.1%
4/33 • Number of events 16 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Gastrointestinal disorders
Mucositis
|
0.00%
0/3 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
0.00%
0/4 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
18.2%
6/33 • Number of events 10 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
66.7%
2/3 • Number of events 5 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
18.2%
6/33 • Number of events 6 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
0.00%
0/4 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
33.3%
11/33 • Number of events 11 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Psychiatric disorders
Confusion
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
0.00%
0/4 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
6.1%
2/33 • Number of events 2 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
0.00%
0/4 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
9.1%
3/33 • Number of events 15 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
0.00%
0/4 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
12.1%
4/33 • Number of events 13 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
General disorders
Fever
|
0.00%
0/3 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
0.00%
0/4 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
18.2%
6/33 • Number of events 14 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Infections and infestations
Urinary Tract Infection
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
50.0%
2/4 • Number of events 7 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
12.1%
4/33 • Number of events 4 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
50.0%
2/4 • Number of events 3 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
12.1%
4/33 • Number of events 4 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
0.00%
0/4 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
18.2%
6/33 • Number of events 8 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
0.00%
0/4 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
12.1%
4/33 • Number of events 8 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
0.00%
0/4 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
9.1%
3/33 • Number of events 3 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
0.00%
0/4 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
15.2%
5/33 • Number of events 5 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/3 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
0.00%
0/4 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
12.1%
4/33 • Number of events 6 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/3 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
0.00%
0/4 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
6.1%
2/33 • Number of events 5 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
0.00%
0/4 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
6.1%
2/33 • Number of events 5 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
0.00%
0/4 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
6.1%
2/33 • Number of events 3 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Investigations
Lipase increased
|
0.00%
0/3 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
0.00%
0/4 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
9.1%
3/33 • Number of events 5 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
0.00%
0/4 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
6.1%
2/33 • Number of events 3 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/3 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
0.00%
0/4 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
6.1%
2/33 • Number of events 3 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.00%
0/3 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
0.00%
0/4 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
6.1%
2/33 • Number of events 3 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/3 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
0.00%
0/4 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
6.1%
2/33 • Number of events 2 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/3 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
0.00%
0/4 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
6.1%
2/33 • Number of events 2 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
33.3%
1/3 • Number of events 2 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
0.00%
0/4 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
12.1%
4/33 • Number of events 6 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
66.7%
2/3 • Number of events 2 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
15.2%
5/33 • Number of events 8 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
—
0/0 • Adverse event data was collected for a period of time over 4 years, 7 months.
No data collected or analyzed for monotherapy as the study was halted early due to funding.
|
Additional Information
Dr. David Gerber
University of Texas Southwestern Medical Center
Phone: 214-648-4180
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place