Trial Outcomes & Findings for Berzosertib and Irinotecan in Treating Patients With Progressive, Metastatic, or Unresectable TP53 Mutant Gastric or Gastroesophageal Junction Cancer (NCT NCT03641313)
NCT ID: NCT03641313
Last Updated: 2025-07-30
Results Overview
Number of patients that achieved either a partial response or complete response as measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 response criteria. Per RECIST v.1.1 assessed by CT or MRI: complete response (CR) is disappearance of all target lesions; partial response (PR) is \>=30% decrease in the sum of the longest diameter of target lesions; Overall response (OR) = CR + PR.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
Up to 1 year
Results posted on
2025-07-30
Participant Flow
Participants were recruited from participating academic medical centers within the Experimental Therapeutics Clinical Trials Network (ETCTN) between 30-Jun-2020 and 01-Dec-2022.
Participant milestones
| Measure |
Treatment (Irinotecan and M6620)
Patients receive irinotecan IV over 90 minutes and berzosertib IV over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo endoscopic or CT assisted biopsy and MRI on study.
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Treatment (Irinotecan and M6620)
Patients receive irinotecan IV over 90 minutes and berzosertib IV over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo endoscopic or CT assisted biopsy and MRI on study.
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Declining health
|
1
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Berzosertib and Irinotecan in Treating Patients With Progressive, Metastatic, or Unresectable TP53 Mutant Gastric or Gastroesophageal Junction Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Irinotecan and M6620)
n=17 Participants
Patients receive irinotecan IV over 90 minutes and berzosertib IV over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo endoscopic or CT assisted biopsy and MRI on study.
|
|---|---|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
63 years
n=5 Participants
|
|
Number of participants included in primary endpoint of objective response rate
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 1 yearNumber of patients that achieved either a partial response or complete response as measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 response criteria. Per RECIST v.1.1 assessed by CT or MRI: complete response (CR) is disappearance of all target lesions; partial response (PR) is \>=30% decrease in the sum of the longest diameter of target lesions; Overall response (OR) = CR + PR.
Outcome measures
| Measure |
Treatment (Irinotecan and M6620)
n=17 Participants
Patients receive irinotecan IV over 90 minutes and berzosertib IV over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo endoscopic or CT assisted biopsy and MRI on study.
|
Platinum Not Sensitive
Patients that has progressive disease within 3 months on a prior platinum-based treatment regimen
|
|---|---|---|
|
Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Response Criteria
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: From when patients achieve their best response (complete response [CR] or partial response [PR]) to when they progress or die for any reason, assessed up to 1 yearPopulation: As 0 participants achieved a response (either complete response or partial response), data for this outcome measure can not be calculated.
As 0 participants achieved a response (either complete response or partial response), data for this outcome measure can not be calculated.
Outcome measures
| Measure |
Treatment (Irinotecan and M6620)
n=17 Participants
Patients receive irinotecan IV over 90 minutes and berzosertib IV over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo endoscopic or CT assisted biopsy and MRI on study.
|
Platinum Not Sensitive
Patients that has progressive disease within 3 months on a prior platinum-based treatment regimen
|
|---|---|---|
|
Duration of Responses (DOR)
|
NA months
As 0 participants achieved a response (either complete response or partial response), data for this outcome measure can not be calculated.
|
—
|
SECONDARY outcome
Timeframe: From start of treatment to time of progression or death from progression, assessed up to 1 yearTime to progression was calculated for all participants. Progression was defined as: 1) using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions; and 2) clinical progression as defined by participant's treating physician. This measure was estimated using the method of Kaplan and Meier and presented with 95% confidence intervals.
Outcome measures
| Measure |
Treatment (Irinotecan and M6620)
n=17 Participants
Patients receive irinotecan IV over 90 minutes and berzosertib IV over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo endoscopic or CT assisted biopsy and MRI on study.
|
Platinum Not Sensitive
Patients that has progressive disease within 3 months on a prior platinum-based treatment regimen
|
|---|---|---|
|
Time to Progression (TTP)
|
3.5 months
Interval 1.8 to 4.8
|
—
|
SECONDARY outcome
Timeframe: From enrollment to disease progression or death for any reason, assessed up to 1 yearProgression-free survival was calculated for all participants. Progression was defined as: 1) using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions; and 2) clinical progression as defined by participant's treating physician. This measure was estimated using the method of Kaplan and Meier and presented with 95% confidence intervals.
Outcome measures
| Measure |
Treatment (Irinotecan and M6620)
n=17 Participants
Patients receive irinotecan IV over 90 minutes and berzosertib IV over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo endoscopic or CT assisted biopsy and MRI on study.
|
Platinum Not Sensitive
Patients that has progressive disease within 3 months on a prior platinum-based treatment regimen
|
|---|---|---|
|
Progression-free Survival (PFS)
|
4.01 months
Interval 2.07 to
NA means that he upper 95% confidence interval was not reached
|
—
|
SECONDARY outcome
Timeframe: From study enrollment to death for any reason, assessed up to 1 yearOverall survival was calculated for all participants. Will be estimated using the method of Kaplan and Meier and presented with 95% confidence intervals.
Outcome measures
| Measure |
Treatment (Irinotecan and M6620)
n=17 Participants
Patients receive irinotecan IV over 90 minutes and berzosertib IV over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo endoscopic or CT assisted biopsy and MRI on study.
|
Platinum Not Sensitive
Patients that has progressive disease within 3 months on a prior platinum-based treatment regimen
|
|---|---|---|
|
Overall Survival (OS)
|
6.21 months
Interval 4.83 to 8.61
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 1 yearPopulation: Three of the 17 patients did not have available prior treatment data to determine if they were platinum sensitive or not sensitive.
Number of participants that had a partial response or complete response to treatment per RECIST v1.1 categorized by platinum sensitivity. Platinum sensitivity was defined as receiving a prior platinum-based therapy for more than 3 months. Per RECIST v.1.1 assessed by CT or MRI: complete response (CR) is disappearance of all target lesions; partial response (PR) is \>=30% decrease in the sum of the longest diameter of target lesions; Overall response (OR) = CR + PR.
Outcome measures
| Measure |
Treatment (Irinotecan and M6620)
n=10 Participants
Patients receive irinotecan IV over 90 minutes and berzosertib IV over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo endoscopic or CT assisted biopsy and MRI on study.
|
Platinum Not Sensitive
n=4 Participants
Patients that has progressive disease within 3 months on a prior platinum-based treatment regimen
|
|---|---|---|
|
ORR in Sub-cohorts Based on First-line Platinum Sensitivity
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 1 yearPopulation: As 0 participants achieved a response (either complete response or partial response), data for this outcome measure can not be calculated.
As 0 participants achieved a response (either complete response or partial response), data for this outcome measure can not be calculated.
Outcome measures
| Measure |
Treatment (Irinotecan and M6620)
n=10 Participants
Patients receive irinotecan IV over 90 minutes and berzosertib IV over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo endoscopic or CT assisted biopsy and MRI on study.
|
Platinum Not Sensitive
n=4 Participants
Patients that has progressive disease within 3 months on a prior platinum-based treatment regimen
|
|---|---|---|
|
DOR in Sub-cohorts Based on First-line Platinum Sensitivity
|
NA months
As 0 participants achieved a response (either complete response or partial response), data for this outcome measure can not be calculated.
|
NA months
As 0 participants achieved a response (either complete response or partial response), data for this outcome measure can not be calculated.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 1 yearPopulation: Three of the 17 patients did not have available prior treatment data to determine if they were platinum sensitive or not sensitive.
Time to progression was calculated for sub cohorts of participants based on sensitivity to prior platinum-based treatment. Progression was defined as: 1) using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions; and 2) clinical progression as defined by participant's treating physician. This measure was estimated using the method of Kaplan and Meier and presented with 95% confidence intervals.
Outcome measures
| Measure |
Treatment (Irinotecan and M6620)
n=10 Participants
Patients receive irinotecan IV over 90 minutes and berzosertib IV over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo endoscopic or CT assisted biopsy and MRI on study.
|
Platinum Not Sensitive
n=4 Participants
Patients that has progressive disease within 3 months on a prior platinum-based treatment regimen
|
|---|---|---|
|
TTP in Sub-cohorts Based on First-line Platinum Sensitivity
|
4.3 months
Interval 1.7 to
NA means that he upper 95% confidence interval was not reached
|
1.9 months
Interval 1.8 to
NA means that he upper 95% confidence interval was not reached
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 1 yearPopulation: Three of the 17 patients did not have available prior treatment data to determine if they were platinum sensitive or not sensitive.
Progression-free survival was calculated for sub cohorts of participants based on sensitivity to prior platinum-based treatment. Progression was defined as: 1) using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions; and 2) clinical progression as defined by participant's treating physician. This measure was estimated using the method of Kaplan and Meier and presented with 95% confidence intervals.
Outcome measures
| Measure |
Treatment (Irinotecan and M6620)
n=10 Participants
Patients receive irinotecan IV over 90 minutes and berzosertib IV over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo endoscopic or CT assisted biopsy and MRI on study.
|
Platinum Not Sensitive
n=4 Participants
Patients that has progressive disease within 3 months on a prior platinum-based treatment regimen
|
|---|---|---|
|
PFS in Sub-cohorts Based on First-line Platinum Sensitivity
|
4.0 months
Interval 1.7 to 4.8
|
1.9 months
Interval 1.8 to
NA means that he upper 95% confidence interval was not reached
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 1 yearPopulation: Three of the 17 patients did not have available prior treatment data to determine if they were platinum sensitive or not sensitive.
Overall survival was calculated for sub cohorts of participants based on sensitivity to prior platinum-based treatment
Outcome measures
| Measure |
Treatment (Irinotecan and M6620)
n=10 Participants
Patients receive irinotecan IV over 90 minutes and berzosertib IV over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo endoscopic or CT assisted biopsy and MRI on study.
|
Platinum Not Sensitive
n=4 Participants
Patients that has progressive disease within 3 months on a prior platinum-based treatment regimen
|
|---|---|---|
|
OS in Sub-cohorts Based on First-line Platinum Sensitivity
|
6.2 months
Interval 3.7 to 7.2
|
4.4 months
Interval 2.1 to
NA means that he upper 95% confidence interval was not reached
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 1 yearMutations present will be summarized as frequency counts and percent of study group.
Outcome measures
| Measure |
Treatment (Irinotecan and M6620)
n=17 Participants
Patients receive irinotecan IV over 90 minutes and berzosertib IV over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo endoscopic or CT assisted biopsy and MRI on study.
|
Platinum Not Sensitive
n=17 Participants
Patients that has progressive disease within 3 months on a prior platinum-based treatment regimen
|
|---|---|---|
|
Presence of Other Deoxyribonucleic Acid (DNA) Damage Response Defects (DDRD)
|
1 Participants
|
1 Participants
|
Adverse Events
Treatment (Irinotecan and M6620)
Serious events: 10 serious events
Other events: 17 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
Treatment (Irinotecan and M6620)
n=17 participants at risk
Patients receive irinotecan IV over 90 minutes and berzosertib IV over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo endoscopic or CT assisted biopsy and MRI on study.
Berzosertib: Given IV
Computed Tomography Assisted Biopsy: Undergo CT assisted biopsy
Endoscopic Biopsy: Undergo endoscopic biopsy
Irinotecan: Given IV
Magnetic Resonance Imaging: Undergo MRI
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
5.9%
1/17 • Number of events 1 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Death NOS
|
5.9%
1/17 • Number of events 1 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Colonic obstruction
|
5.9%
1/17 • Number of events 1 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
17.6%
3/17 • Number of events 3 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
5.9%
1/17 • Number of events 1 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Enterocolitis infectious
|
5.9%
1/17 • Number of events 1 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Lymphocyte count decreased
|
5.9%
1/17 • Number of events 1 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Nausea
|
5.9%
1/17 • Number of events 1 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Sepsis
|
5.9%
1/17 • Number of events 1 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Vascular disorders
Superior vena cava syndrome
|
5.9%
1/17 • Number of events 1 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Urosepsis
|
5.9%
1/17 • Number of events 2 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
1/17 • Number of events 1 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Weight loss
|
5.9%
1/17 • Number of events 1 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
Other adverse events
| Measure |
Treatment (Irinotecan and M6620)
n=17 participants at risk
Patients receive irinotecan IV over 90 minutes and berzosertib IV over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo endoscopic or CT assisted biopsy and MRI on study.
Berzosertib: Given IV
Computed Tomography Assisted Biopsy: Undergo CT assisted biopsy
Endoscopic Biopsy: Undergo endoscopic biopsy
Irinotecan: Given IV
Magnetic Resonance Imaging: Undergo MRI
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
5.9%
1/17 • Number of events 1 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Abdominal pain
|
17.6%
3/17 • Number of events 4 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
5.9%
1/17 • Number of events 1 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Renal and urinary disorders
Acute kidney injury
|
5.9%
1/17 • Number of events 1 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Alanine aminotransferase increased
|
17.6%
3/17 • Number of events 5 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Alkaline phosphatase increased
|
29.4%
5/17 • Number of events 30 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
17.6%
3/17 • Number of events 20 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Blood and lymphatic system disorders
Anemia
|
52.9%
9/17 • Number of events 53 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Anorexia
|
35.3%
6/17 • Number of events 14 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Psychiatric disorders
Anxiety
|
11.8%
2/17 • Number of events 9 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Ascites
|
17.6%
3/17 • Number of events 5 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Aspartate aminotransferase increased
|
17.6%
3/17 • Number of events 6 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
1/17 • Number of events 1 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Bloating
|
11.8%
2/17 • Number of events 4 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Blood bicarbonate decreased
|
5.9%
1/17 • Number of events 1 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Blood lactate dehydrogenase increased
|
17.6%
3/17 • Number of events 13 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.9%
1/17 • Number of events 1 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Bubbling saliva
|
5.9%
1/17 • Number of events 4 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Cardiac disorders
Chest pain - cardiac
|
5.9%
1/17 • Number of events 1 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
5.9%
1/17 • Number of events 2 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Immune system disorders
Cholinergic reaction
|
5.9%
1/17 • Number of events 3 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Cognitive disturbance
|
5.9%
1/17 • Number of events 1 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Psychiatric disorders
Confusion
|
5.9%
1/17 • Number of events 1 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Constipation
|
5.9%
1/17 • Number of events 4 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.8%
2/17 • Number of events 6 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Creatinine increased
|
11.8%
2/17 • Number of events 11 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Psychiatric disorders
Delirium
|
5.9%
1/17 • Number of events 1 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Psychiatric disorders
Depression
|
5.9%
1/17 • Number of events 1 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Diarrhea
|
58.8%
10/17 • Number of events 50 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Dizziness
|
23.5%
4/17 • Number of events 6 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.9%
1/17 • Number of events 2 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Dysphagia
|
5.9%
1/17 • Number of events 1 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.9%
1/17 • Number of events 1 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Ear and labyrinth disorders
ear fullness bilateral
|
5.9%
1/17 • Number of events 8 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Edema limbs
|
17.6%
3/17 • Number of events 10 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Renal and urinary disorders
Elevated eGFR
|
5.9%
1/17 • Number of events 3 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Enterocolitis
|
5.9%
1/17 • Number of events 1 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
5.9%
1/17 • Number of events 1 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Fatigue
|
47.1%
8/17 • Number of events 26 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Fever
|
5.9%
1/17 • Number of events 2 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
5.9%
1/17 • Number of events 2 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Flatulence
|
5.9%
1/17 • Number of events 1 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
11.8%
2/17 • Number of events 3 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Gastroparesis
|
5.9%
1/17 • Number of events 6 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Reproductive system and breast disorders
Genital edema
|
5.9%
1/17 • Number of events 1 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Renal and urinary disorders
Hematuria
|
11.8%
2/17 • Number of events 13 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
5.9%
1/17 • Number of events 1 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
17.6%
3/17 • Number of events 10 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.9%
1/17 • Number of events 2 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Vascular disorders
Hypertension
|
11.8%
2/17 • Number of events 5 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
41.2%
7/17 • Number of events 24 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
23.5%
4/17 • Number of events 7 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
23.5%
4/17 • Number of events 6 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.9%
1/17 • Number of events 1 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
35.3%
6/17 • Number of events 21 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
11.8%
2/17 • Number of events 10 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Vascular disorders
Hypotension
|
17.6%
3/17 • Number of events 3 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Ileus
|
5.9%
1/17 • Number of events 1 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Inflamed seborrheic keratosis on upper chest
|
5.9%
1/17 • Number of events 1 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Psychiatric disorders
Insomnia
|
5.9%
1/17 • Number of events 8 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Lymphocyte count decreased
|
41.2%
7/17 • Number of events 39 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Mucositis oral
|
5.9%
1/17 • Number of events 1 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Ear and labyrinth disorders
Muffled hearing
|
5.9%
1/17 • Number of events 1 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
5.9%
1/17 • Number of events 5 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Nausea
|
70.6%
12/17 • Number of events 42 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Neutrophil count decreased
|
35.3%
6/17 • Number of events 6 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Non-cardiac chest pain
|
11.8%
2/17 • Number of events 2 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Pain
|
5.9%
1/17 • Number of events 2 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Paresthesia
|
5.9%
1/17 • Number of events 2 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.8%
2/17 • Number of events 15 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Platelet count decreased
|
11.8%
2/17 • Number of events 5 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
11.8%
2/17 • Number of events 6 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Pyelonephritis
|
5.9%
1/17 • Number of events 1 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Red bump on abdomen
|
5.9%
1/17 • Number of events 3 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
5.9%
1/17 • Number of events 3 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Sepsis
|
11.8%
2/17 • Number of events 2 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Cardiac disorders
Sinus tachycardia
|
5.9%
1/17 • Number of events 1 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Skin infection
|
5.9%
1/17 • Number of events 1 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Spasticity
|
5.9%
1/17 • Number of events 1 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Vascular disorders
Thromboembolic event
|
11.8%
2/17 • Number of events 8 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Renal and urinary disorders
Urinary frequency
|
5.9%
1/17 • Number of events 4 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Renal and urinary disorders
Urinary retention
|
5.9%
1/17 • Number of events 4 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Urinary tract infection
|
11.8%
2/17 • Number of events 2 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Renal and urinary disorders
Urine discoloration
|
5.9%
1/17 • Number of events 2 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Vomiting
|
35.3%
6/17 • Number of events 25 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Weight loss
|
11.8%
2/17 • Number of events 7 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
White blood cell decreased
|
41.2%
7/17 • Number of events 17 • Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60