Trial Outcomes & Findings for Niraparib + Dostarlimab + RT in Pancreatic Cancer (NCT NCT04409002)
NCT ID: NCT04409002
Last Updated: 2025-08-15
Results Overview
Disease control rate (DCR) is the percentage of participants who experienced a complete response (CR), partial response (PR), or stable disease (SD) assessed by the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria below. * CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * PR = At least 30% decrease in the sum of longest diameters of target lesions, taking as reference the baseline sum diameters. * SD = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the baseline sum diameters while on study. * Progressive Disease (PD) = At least 20% increase in the sum of longest diameters of target lesions, taking as reference the baseline sum diameters while on study. Appearance of one or more new lesions is also considered progression.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
up to 17 months
Results posted on
2025-08-15
Participant Flow
Participant milestones
| Measure |
Niraparib+Dostarlimab + Radiation
Each study treatment cycle lasts 21 days
* Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment
* Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study
* Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1
Niraparib: Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment
Dostarlimab: Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study
Radiation: Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Niraparib+Dostarlimab + Radiation
Each study treatment cycle lasts 21 days
* Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment
* Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study
* Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1
Niraparib: Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment
Dostarlimab: Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study
Radiation: Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1
|
|---|---|
|
Overall Study
Disease progression prior to starting study treatment
|
3
|
Baseline Characteristics
Niraparib + Dostarlimab + RT in Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Niraparib+Dostarlimab + Radiation
n=18 Participants
Each study treatment cycle lasts 21 days
* Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment
* Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study
* Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1
Niraparib: Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment
Dostarlimab: Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study
Radiation: Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1
|
|---|---|
|
Age, Customized
Age 30-39 years
|
2 Participants
n=5 Participants
|
|
Age, Customized
Age 40-49 years
|
1 Participants
n=5 Participants
|
|
Age, Customized
Age 50-59 years
|
5 Participants
n=5 Participants
|
|
Age, Customized
Age 60-69 years
|
7 Participants
n=5 Participants
|
|
Age, Customized
Age 70-79 years
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 17 monthsDisease control rate (DCR) is the percentage of participants who experienced a complete response (CR), partial response (PR), or stable disease (SD) assessed by the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria below. * CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * PR = At least 30% decrease in the sum of longest diameters of target lesions, taking as reference the baseline sum diameters. * SD = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the baseline sum diameters while on study. * Progressive Disease (PD) = At least 20% increase in the sum of longest diameters of target lesions, taking as reference the baseline sum diameters while on study. Appearance of one or more new lesions is also considered progression.
Outcome measures
| Measure |
Niraparib+Dostarlimab + Radiation
n=15 Participants
Each study treatment cycle lasts 21 days
* Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment
* Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study
* Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1
Niraparib: Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment
Dostarlimab: Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study
Radiation: Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1
|
|---|---|
|
Disease Control Rate With RECIST 1.1 Criteria
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 17 monthsDisease control rate (DCR) is the percentage of participants who experienced a immune-related complete response (irCR), partial response (irPR), or stable disease (irSD) assessed by the Immune-Related Response Evaluation Criteria In Solid Tumors (irRECIST) criteria below. * irCR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * irPR = At least 30% decrease in the sum of longest diameters of target lesions, compared to baseline. * irSD = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, compared to baseline. * Immune-related Progressive Disease (irPD) = At least 20% increase in the sum of longest diameters of target lesions AND at least 5mm absolute increase, compared to baseline. Appearance of one or more new lesions is also considered progression. Confirmation scan required at least 4 weeks later.
Outcome measures
| Measure |
Niraparib+Dostarlimab + Radiation
n=15 Participants
Each study treatment cycle lasts 21 days
* Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment
* Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study
* Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1
Niraparib: Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment
Dostarlimab: Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study
Radiation: Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1
|
|---|---|
|
Disease Control Rate With irRECIST Criteria
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 17 monthsProgression-free survival (PFS) is defined as the time duration from the first day of protocol treatment to the earlier date of disease progression or death due to any cause. PFS time will be censored at the date of last follow-up for surviving patients with disease control.
Outcome measures
| Measure |
Niraparib+Dostarlimab + Radiation
n=15 Participants
Each study treatment cycle lasts 21 days
* Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment
* Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study
* Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1
Niraparib: Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment
Dostarlimab: Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study
Radiation: Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1
|
|---|---|
|
Progression-free Survival
|
1.6 months
Interval 1.1 to 2.7
|
SECONDARY outcome
Timeframe: up to 17 monthsOverall survival (OS) is defined as the time duration from the first day of protocol treatment to the date of death due to any cause, and will be censored at the date of last follow-up for patients still alive.
Outcome measures
| Measure |
Niraparib+Dostarlimab + Radiation
n=15 Participants
Each study treatment cycle lasts 21 days
* Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment
* Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study
* Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1
Niraparib: Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment
Dostarlimab: Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study
Radiation: Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1
|
|---|---|
|
Overall Survival
|
3.1 months
Interval 1.5 to 7.7
|
SECONDARY outcome
Timeframe: up to 19 weeksTreatment-related adverse events (TRAEs) are evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, as grades 3-5 and at least possibly attributed to study treatment. TRAEs are evaluated from the start of study treatment through 30-days after the last treatment dose.
Outcome measures
| Measure |
Niraparib+Dostarlimab + Radiation
n=15 Participants
Each study treatment cycle lasts 21 days
* Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment
* Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study
* Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1
Niraparib: Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment
Dostarlimab: Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study
Radiation: Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1
|
|---|---|
|
Number of Treatment-Related Adverse Events Per CTCAE v5.0
Grade 3 TRAEs
|
17 treatment-related adverse events
|
|
Number of Treatment-Related Adverse Events Per CTCAE v5.0
Grade 4 TRAEs
|
3 treatment-related adverse events
|
|
Number of Treatment-Related Adverse Events Per CTCAE v5.0
Grade 5 TRAEs
|
0 treatment-related adverse events
|
Adverse Events
Niraparib+Dostarlimab + Radiation
Serious events: 2 serious events
Other events: 15 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
Niraparib+Dostarlimab + Radiation
n=15 participants at risk
Each study treatment cycle lasts 21 days
* Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment
* Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study
* Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1
Niraparib: Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment
Dostarlimab: Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study
Radiation: Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1
|
|---|---|
|
General disorders
Fever
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Nervous system disorders
Stroke
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
Other adverse events
| Measure |
Niraparib+Dostarlimab + Radiation
n=15 participants at risk
Each study treatment cycle lasts 21 days
* Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment
* Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study
* Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1
Niraparib: Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment
Dostarlimab: Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study
Radiation: Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
33.3%
5/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Gastrointestinal disorders
Abdominal pain
|
73.3%
11/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Investigations
Alanine aminotransferase increased
|
13.3%
2/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Investigations
Alkaline phosphatase increased
|
66.7%
10/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Blood and lymphatic system disorders
Anemia
|
80.0%
12/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Metabolism and nutrition disorders
Anorexia
|
60.0%
9/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Psychiatric disorders
Anxiety
|
46.7%
7/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Cardiac disorders
Aortic valve disease
|
33.3%
5/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Gastrointestinal disorders
Ascites
|
26.7%
4/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Investigations
Aspartate aminotransferase increased
|
13.3%
2/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
5/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Infections and infestations
Bacteremia
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Infections and infestations
Biliary tract infection
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Gastrointestinal disorders
Bloating
|
13.3%
2/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Investigations
Blood bilirubin increased
|
40.0%
6/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Investigations
Blood lactate dehydrogenase increased
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Investigations
Cardiac troponin T increased
|
13.3%
2/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Investigations
CD4 lymphocytes decreased
|
66.7%
10/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
General disorders
Chills
|
26.7%
4/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Psychiatric disorders
Confusion
|
13.3%
2/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Gastrointestinal disorders
Constipation
|
60.0%
9/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
3/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Metabolism and nutrition disorders
Dehydration
|
13.3%
2/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Psychiatric disorders
Delirium
|
20.0%
3/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Psychiatric disorders
Depression
|
26.7%
4/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
5/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Nervous system disorders
Dizziness
|
20.0%
3/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Gastrointestinal disorders
Dry mouth
|
13.3%
2/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Nervous system disorders
Dysgeusia
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Gastrointestinal disorders
Dysphagia
|
13.3%
2/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
40.0%
6/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Renal and urinary disorders
Dysuria
|
13.3%
2/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
General disorders
Edema limbs
|
33.3%
5/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Nervous system disorders
Encephalopathy
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Infections and infestations
Endocarditis infective
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Eye disorders
Eye disorders - Other, specify
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Injury, poisoning and procedural complications
Fall
|
13.3%
2/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
General disorders
Fatigue
|
80.0%
12/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
General disorders
Fever
|
33.3%
5/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Gastrointestinal disorders
Flatulence
|
13.3%
2/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Injury, poisoning and procedural complications
Gastric anastomotic leak
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Gastrointestinal disorders
Gastric ulcer
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Gastrointestinal disorders
Gastritis
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
13.3%
2/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Renal and urinary disorders
Glucosuria
|
13.3%
2/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Renal and urinary disorders
Hematuria
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
13.3%
2/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
13.3%
2/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
53.3%
8/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
13.3%
2/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Vascular disorders
Hypertension
|
40.0%
6/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
46.7%
7/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
33.3%
5/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Metabolism and nutrition disorders
Hypokalemia
|
13.3%
2/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Metabolism and nutrition disorders
Hyponatremia
|
26.7%
4/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
13.3%
2/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Endocrine disorders
Hypothyroidism
|
13.3%
2/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Psychiatric disorders
Insomnia
|
13.3%
2/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Nervous system disorders
Lethargy
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
General disorders
Localized edema
|
13.3%
2/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Investigations
Lymphocyte count decreased
|
20.0%
3/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Nervous system disorders
Memory impairment
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Gastrointestinal disorders
Mucositis oral
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Cardiac disorders
Myocarditis
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Gastrointestinal disorders
Nausea
|
66.7%
10/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Investigations
Neutrophil count decreased
|
13.3%
2/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Metabolism and nutrition disorders
Obesity
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Gastrointestinal disorders
Oral hemorrhage
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Gastrointestinal disorders
Oral pain
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
General disorders
Pain
|
20.0%
3/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.3%
2/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Cardiac disorders
Palpitations
|
13.3%
2/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Skin and subcutaneous tissue disorders
Papulopustular rash
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Nervous system disorders
Paresthesia
|
20.0%
3/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Reproductive system and breast disorders
Pelvic pain
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Nervous system disorders
Peripheral motor neuropathy
|
40.0%
6/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Investigations
Platelet count decreased
|
53.3%
8/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Gastrointestinal disorders
Rectal pain
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Renal and urinary disorders
Renal calculi
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Psychiatric disorders
Restlessness
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Eye disorders
Scleral disorder
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Infections and infestations
Sepsis
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Cardiac disorders
Sinus tachycardia
|
33.3%
5/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Infections and infestations
Skin infection
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
20.0%
3/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Nervous system disorders
Stroke
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Vascular disorders
Superficial thrombophlebitis
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Vascular disorders
Thromboembolic event
|
46.7%
7/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Infections and infestations
Thrush
|
13.3%
2/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Investigations
Thyroid stimulating hormone increased
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Nervous system disorders
Tremor
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Renal and urinary disorders
Urinary frequency
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Renal and urinary disorders
Urinary retention
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Renal and urinary disorders
Urine discoloration
|
20.0%
3/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Reproductive system and breast disorders
Vaginal dryness
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
6/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Investigations
Weight loss
|
46.7%
7/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
6.7%
1/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
|
Investigations
White blood cell decreased
|
26.7%
4/15 • up to 17 months
Adverse event evaluations per CTCAE v5.0
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place