Trial Outcomes & Findings for Study Evaluating the Efficacy of Niraparib and Dostarlimab (TSR-042) in Recurrent/Metastatic HNSCC (NCT NCT04313504)
NCT ID: NCT04313504
Last Updated: 2026-05-07
Results Overview
Measured by assessing best overall response using RECIST 1.1 in subjects in recurrent and/or metastatic HNSCC patients receiving combination of niraparib and dostarlimab.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
8 weeks
Results posted on
2026-05-07
Participant Flow
Participant milestones
| Measure |
Niraparib & Dostarlimab
Niraparib starting on Day 0. Niraparib will be administered as continuous daily dose, orally 200 or 300 mg.
Dostarlimab IV administered via a 30-minute infusion on Day 1 of every 21 day cycle. 500mg for first 4 doses followed by 1000 mg every 6 weeks.
Niraparib: Niraparib \& Dostarlimab combination
Dostarlimab: Niraparib \& Dostarlimab combination
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study Evaluating the Efficacy of Niraparib and Dostarlimab (TSR-042) in Recurrent/Metastatic HNSCC
Baseline characteristics by cohort
| Measure |
Niraparib & Dostarlimab
n=10 Participants
Niraparib starting on Day 0. Niraparib will be administered as continuous daily dose, orally 200 or 300 mg.
Dostarlimab IV administered via a 30-minute infusion on Day 1 of every 21 day cycle. 500mg for first 4 doses followed by 1000 mg every 6 weeks.
Niraparib: Niraparib \& Dostarlimab combination
Dostarlimab: Niraparib \& Dostarlimab combination
|
|---|---|
|
Age, Continuous
|
62.5 years
n=54 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=54 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=54 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=54 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=54 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=54 Participants
|
|
ECOG
ECOG Score of 0
|
4 Participants
n=54 Participants
|
|
ECOG
ECOG Score of 1
|
6 Participants
n=54 Participants
|
PRIMARY outcome
Timeframe: 8 weeksMeasured by assessing best overall response using RECIST 1.1 in subjects in recurrent and/or metastatic HNSCC patients receiving combination of niraparib and dostarlimab.
Outcome measures
| Measure |
Niraparib & Dostarlimab
n=10 Participants
Niraparib starting on Day 0. Niraparib will be administered as continuous daily dose, orally 200 or 300 mg.
Dostarlimab IV administered via a 30-minute infusion on Day 1 of every 21 day cycle. 500mg for first 4 doses followed by 1000 mg every 6 weeks.
Niraparib: Niraparib \& Dostarlimab combination
Dostarlimab: Niraparib \& Dostarlimab combination
|
|---|---|
|
Overall Response
Complete Response
|
0 Participants
|
|
Overall Response
Partial Response
|
1 Participants
|
|
Overall Response
Stable Disease
|
1 Participants
|
|
Overall Response
Progressive Disease
|
8 Participants
|
SECONDARY outcome
Timeframe: 1 and 3 yearsPopulation: 10 eligible participants that received one prior line of treatment in the recurrent/metastatic setting, with all but one patient having previously failed a PD-1 or PD-L1 inhibitor
Measured using Kaplan Meier Curves from time of treatment start until time of progression
Outcome measures
| Measure |
Niraparib & Dostarlimab
n=10 Participants
Niraparib starting on Day 0. Niraparib will be administered as continuous daily dose, orally 200 or 300 mg.
Dostarlimab IV administered via a 30-minute infusion on Day 1 of every 21 day cycle. 500mg for first 4 doses followed by 1000 mg every 6 weeks.
Niraparib: Niraparib \& Dostarlimab combination
Dostarlimab: Niraparib \& Dostarlimab combination
|
|---|---|
|
Progression Free Survival
|
3.8 months
Interval 1.63 to
Upper limit CIs are not available due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Through study completion, an average of 10 monthsPopulation: 10 eligible participants that received one prior line of treatment in the recurrent/metastatic setting, with all but one patient having previously failed a PD-1 or PD-L1 inhibitor
Measured using Kaplan Meier Curves from diagnosis until time of death
Outcome measures
| Measure |
Niraparib & Dostarlimab
n=10 Participants
Niraparib starting on Day 0. Niraparib will be administered as continuous daily dose, orally 200 or 300 mg.
Dostarlimab IV administered via a 30-minute infusion on Day 1 of every 21 day cycle. 500mg for first 4 doses followed by 1000 mg every 6 weeks.
Niraparib: Niraparib \& Dostarlimab combination
Dostarlimab: Niraparib \& Dostarlimab combination
|
|---|---|
|
Overall Survival
|
10.1 months
Interval 2.06 to
Upper limit CIs are not available due to insufficient number of participants with events.
|
Adverse Events
Niraparib & Dostarlimab
Serious events: 6 serious events
Other events: 10 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Niraparib & Dostarlimab
n=10 participants at risk
Niraparib starting on Day 0. Niraparib will be administered as continuous daily dose, orally 200 or 300 mg.
Dostarlimab IV administered via a 30-minute infusion on Day 1 of every 21 day cycle. 500mg for first 4 doses followed by 1000 mg every 6 weeks.
Niraparib: Niraparib \& Dostarlimab combination
Dostarlimab: Niraparib \& Dostarlimab combination
|
|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
100.0%
1/1 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Nervous system disorders
Cognitive disturbance
|
10.0%
1/10 • Number of events 2 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Metabolism and nutrition disorders
Dehydration
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
10.0%
1/10 • Number of events 2 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.0%
2/10 • Number of events 4 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Infections and infestations
Lung infection
|
20.0%
2/10 • Number of events 2 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Gastrointestinal disorders
Oropharyngeal Hemorrhage
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Injury, poisoning and procedural complications
Tracheal obstruction
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Injury, poisoning and procedural complications
Tracheostomy site bleeding
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Infections and infestations
Wound infection
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
Other adverse events
| Measure |
Niraparib & Dostarlimab
n=10 participants at risk
Niraparib starting on Day 0. Niraparib will be administered as continuous daily dose, orally 200 or 300 mg.
Dostarlimab IV administered via a 30-minute infusion on Day 1 of every 21 day cycle. 500mg for first 4 doses followed by 1000 mg every 6 weeks.
Niraparib: Niraparib \& Dostarlimab combination
Dostarlimab: Niraparib \& Dostarlimab combination
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Renal and urinary disorders
Acute kidney injury
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Endocrine disorders
Adrenal insufficiency
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Psychiatric disorders
Agitation
|
10.0%
1/10 • Number of events 3 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Investigations
Alkaline phosphatase increased
|
20.0%
2/10 • Number of events 2 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
20.0%
2/10 • Number of events 2 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Blood and lymphatic system disorders
Anemia
|
10.0%
1/10 • Number of events 2 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Metabolism and nutrition disorders
Anorexia
|
30.0%
3/10 • Number of events 4 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Psychiatric disorders
Anxiety
|
20.0%
2/10 • Number of events 3 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
1/10 • Number of events 2 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Gastrointestinal disorders
Bloating
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Eye disorders
Blurred vision
|
20.0%
2/10 • Number of events 2 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial stricture
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Injury, poisoning and procedural complications
Bruising
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
General disorders
Chills
|
20.0%
2/10 • Number of events 2 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
General disorders
Cervical adenopathy
|
20.0%
2/10 • Number of events 2 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Renal and urinary disorders
Chronic kidney disease
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Gastrointestinal disorders
Constipation
|
40.0%
4/10 • Number of events 4 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
2/10 • Number of events 2 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Investigations
Creatinine increased
|
30.0%
3/10 • Number of events 3 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Metabolism and nutrition disorders
Dehydration
|
40.0%
4/10 • Number of events 6 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
1/10 • Number of events 2 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
20.0%
2/10 • Number of events 2 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Gastrointestinal disorders
Dysphagia
|
30.0%
3/10 • Number of events 3 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
40.0%
4/10 • Number of events 4 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Ear and labyrinth disorders
Ear pain
|
20.0%
2/10 • Number of events 2 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
General disorders
Edema face
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Nervous system disorders
Facial muscle weakness
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
General disorders
Fatigue
|
80.0%
8/10 • Number of events 9 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
General disorders
Flu like symptoms
|
20.0%
2/10 • Number of events 2 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Vascular disorders
Flushing
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Gastrointestinal disorders
Coughing up gastric contents
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
General disorders
Neck stiffness
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
General disorders
Cervical lymphadenopathy
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
General disorders
Lightheadedness
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Psychiatric disorders
Hallucinations
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Nervous system disorders
Headache
|
20.0%
2/10 • Number of events 2 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Vascular disorders
Hypertension
|
30.0%
3/10 • Number of events 8 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Endocrine disorders
Hyperthyroidism
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.0%
1/10 • Number of events 2 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.0%
1/10 • Number of events 2 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Endocrine disorders
Hypothyroidism
|
20.0%
2/10 • Number of events 2 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Infections and infestations
Jaw infection
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Psychiatric disorders
Insomnia
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Investigations
BUN Increased
|
30.0%
3/10 • Number of events 3 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
General disorders
Localized edema
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Nervous system disorders
Memory impairment
|
10.0%
1/10 • Number of events 2 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Metabolism and nutrition disorders
Appetite change
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Musculoskeletal and connective tissue disorders
Right jaw cramps
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Musculoskeletal and connective tissue disorders
Difficulty Chewing
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Musculoskeletal and connective tissue disorders
Neck stiffness
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Gastrointestinal disorders
Nausea
|
80.0%
8/10 • Number of events 16 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
General disorders
Neck edema
|
20.0%
2/10 • Number of events 2 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Gastrointestinal disorders
Oral pain
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
General disorders
Pain
|
20.0%
2/10 • Number of events 2 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Cardiac disorders
Palpitations
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Investigations
Platelet count decreased
|
30.0%
3/10 • Number of events 5 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Renal and urinary disorders
Difficulty urinating
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration pneumonia
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Cardiac disorders
Sinus tachycardia
|
20.0%
2/10 • Number of events 2 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Skin and subcutaneous tissue disorders
Pendunculated lesion
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
20.0%
2/10 • Number of events 2 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Surgical and medical procedures
Teeth extractions
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Infections and infestations
Thrush
|
10.0%
1/10 • Number of events 2 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Investigations
Thyroid stimulating hormone increased
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Gastrointestinal disorders
Toothache
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
5/10 • Number of events 5 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Investigations
Weight loss
|
60.0%
6/10 • Number of events 24 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Investigations
White blood cell decreased
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
|
Infections and infestations
Wound infection
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the start of protocol treatment through the last dose of protocol treatment, and up to 90 days following the final dose, up to 28 months.
Definitions do not differ from clinicaltrials.gov.
|
Additional Information
Trisha Wise-Draper M.D., Ph.D.
University of Cincinnati
Phone: (513) 558-2826
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place