Trial Outcomes & Findings for Study of SBRT/Olaparib Followed by Pembrolizumab/Olaparib in Gastric Cancers (NCT NCT05379972)
NCT ID: NCT05379972
Last Updated: 2026-05-04
Results Overview
The proportion of patients with a complete response or partial response to treatment according to Immune Response Evaluation Criteria in Solid Tumors (iRECIST 1.1)
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
2 years
Results posted on
2026-05-04
Participant Flow
Participant milestones
| Measure |
HR Deficient Cohort
Pre-identified presence of somatic or germline deleterious mutation, as determined by NGS only, in at least one gene critical to DNA repair through homologous recombination, including but not limited to: ARID1A, ATM, ATRX, MRE11A, NBN, PTEN, RAD50/51/51B, BARD1, BLM, BRCA1, BRCA2, BRIP1, FANCA/C/D2/E/F/G/L, PALB2, WRN, CHEK2, CHEK1, BAP1, FAM175A, SLX4, MLL2 or XRCC.
Pembrolizumab: Pembrolizumab 200mg IV every 3 weeks starting C2D1
Olaparib: Olaparib 200mg orally twice daily starting C1D1 concurrently with radiation. Starting C2D1, Olaparib 300mg orally twice with Pembrolizumab
Stereotactic Body Radiation Therapy: Stereotactic Body Radiation Therapy Dose 25Gy in 5 fractions daily (M-F) for 5 days starting C1D1 with Olaparib
|
HR Proficient Cohort
No identifiable somatic or germline deleterious mutation in DNA Response and Repair pathway
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
|
Overall Study
COMPLETED
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of SBRT/Olaparib Followed by Pembrolizumab/Olaparib in Gastric Cancers
Baseline characteristics by cohort
| Measure |
HR Deficient Cohort
n=5 Participants
Pre-identified presence of somatic or germline deleterious mutation, as determined by NGS only, in at least one gene critical to DNA repair through homologous recombination, including but not limited to: ARID1A, ATM, ATRX, MRE11A, NBN, PTEN, RAD50/51/51B, BARD1, BLM, BRCA1, BRCA2, BRIP1, FANCA/C/D2/E/F/G/L, PALB2, WRN, CHEK2, CHEK1, BAP1, FAM175A, SLX4, MLL2 or XRCC.
Pembrolizumab: Pembrolizumab 200mg IV every 3 weeks starting C2D1
Olaparib: Olaparib 200mg orally twice daily starting C1D1 concurrently with radiation. Starting C2D1, Olaparib 300mg orally twice with Pembrolizumab
Stereotactic Body Radiation Therapy: Stereotactic Body Radiation Therapy Dose 25Gy in 5 fractions daily (M-F) for 5 days starting C1D1 with Olaparib
|
HR Proficient Cohort
n=4 Participants
No identifiable somatic or germline deleterious mutation in DNA Response and Repair pathway
Pembrolizumab: Pembrolizumab 200mg IV every 3 weeks starting C2D1
Olaparib: Olaparib 200mg orally twice daily starting C1D1 concurrently with radiation. Starting C2D1, Olaparib 300mg orally twice with Pembrolizumab
Stereotactic Body Radiation Therapy: Stereotactic Body Radiation Therapy Dose 25Gy in 5 fractions daily (M-F) for 5 days starting C1D1 with Olaparib
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 year
n=54 Participants
|
54.5 year
n=60 Participants
|
58 year
n=114 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
2 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=54 Participants
|
4 Participants
n=60 Participants
|
7 Participants
n=114 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=54 Participants
|
4 Participants
n=60 Participants
|
8 Participants
n=114 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
2 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=54 Participants
|
3 Participants
n=60 Participants
|
7 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=54 Participants
|
4 Participants
n=60 Participants
|
9 Participants
n=114 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: All patients who met eligibility criteria and received at least one dose of study treatment. Patients without post-baseline tumor assessments will be considered non-responders.
The proportion of patients with a complete response or partial response to treatment according to Immune Response Evaluation Criteria in Solid Tumors (iRECIST 1.1)
Outcome measures
| Measure |
HR Deficient
n=5 Participants
Pre-identified presence of somatic or germline deleterious mutation, as determined by NGS only, in at least one gene critical to DNA repair through homologous recombination, including but not limited to: ARID1A, ATM, ATRX, MRE11A, NBN, PTEN, RAD50/51/51B, BARD1, BLM, BRCA1, BRCA2, BRIP1, FANCA/C/D2/E/F/G/L, PALB2, WRN, CHEK2, CHEK1, BAP1, FAM175A, SLX4, MLL2 or XRCC.
Pembrolizumab: Pembrolizumab 200mg IV every 3 weeks starting C2D1 Olaparib: Olaparib 200mg orally twice daily starting C1D1 concurrently with radiation. Starting C2D1, Olaparib 300mg orally twice with Pembrolizumab Stereotactic Body Radiation Therapy: Stereotactic Body Radiation Therapy Dose 25Gy in 5 fractions daily (M-F) for 5 days starting C1D1.
|
HR Proficient
n=4 Participants
No identifiable somatic or germline deleterious mutation in DNA Response and Repair pathway.
Pembrolizumab: Pembrolizumab 200mg IV every 3 weeks starting C2D1 Olaparib: Olaparib 200mg orally twice daily starting C1D1 concurrently with radiation. Starting C2D1, Olaparib 300mg orally twice with Pembrolizumab Stereotactic Body Radiation Therapy: Stereotactic Body Radiation Therapy Dose 25Gy in 5 fractions daily (M-F) for 5 days starting C1D1.
|
Overall Cohort
n=9 Participants
HR deficient + HR proficient
|
|---|---|---|---|
|
Objective Response Rate (ORR) of Unirradiated Tumors
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 4 yearsTime from initiation of therapy to the date of death or to the date of last follow-up
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 yearsTime from initiation of therapy to the date of progression or to the date of last follow-up
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 yearsTime from documentation of tumor response to disease progression
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 yearsDefined as the sum of partial response (PR), complete response (CR) and stable disease (SD)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 yearsCTCAE v5.0 defined Treatment-Related Adverse Events
Outcome measures
Outcome data not reported
Adverse Events
HR Deficient
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
HR Proficient
Serious events: 3 serious events
Other events: 4 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
HR Deficient
n=5 participants at risk
Pre-identified presence of somatic or germline deleterious mutation, as determined by NGS only, in at least one gene critical to DNA repair through homologous recombination, including but not limited to: ARID1A, ATM, ATRX, MRE11A, NBN, PTEN, RAD50/51/51B, BARD1, BLM, BRCA1, BRCA2, BRIP1, FANCA/C/D2/E/F/G/L, PALB2, WRN, CHEK2, CHEK1, BAP1, FAM175A, SLX4, MLL2 or XRCC.
|
HR Proficient
n=4 participants at risk
No identifiable somatic or germline deleterious mutation in DNA Response and Repair pathway
|
|---|---|---|
|
Gastrointestinal Disorders
Dysphagia
|
20.0%
1/5 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
25.0%
1/4 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Gastrointestinal Disorders
Esophageal stenosis
|
0.00%
0/5 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
25.0%
1/4 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Gastrointestinal Disorders
Gastrointestinal disorders - Other, specify
|
20.0%
1/5 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
25.0%
1/4 • Number of events 2 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Gastrointestinal Disorders
Nausea
|
0.00%
0/5 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
25.0%
1/4 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Gastrointestinal Disorders
Vomiting
|
20.0%
1/5 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
0.00%
0/4 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
General Disorders
Death NOS
|
0.00%
0/5 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
25.0%
1/4 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
General Disorders
General disorders and administration site conditions - Other, specify
|
20.0%
1/5 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
0.00%
0/4 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Infections and Infestations
Sepsis
|
0.00%
0/5 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
25.0%
1/4 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Metabolism and Nutrition Disorders
Dehydration
|
0.00%
0/5 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
25.0%
1/4 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Neoplasms Benign, Malignant and Unspecified (Including Cysts and Polyps)
Disease progression
|
20.0%
1/5 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
0.00%
0/4 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Nervous System Disorders
Confusion
|
0.00%
0/5 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
25.0%
1/4 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Vascular Disorders
Hypotension
|
0.00%
0/5 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
25.0%
1/4 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Vascular Disorders
Thromboembolic event
|
0.00%
0/5 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
25.0%
1/4 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
Other adverse events
| Measure |
HR Deficient
n=5 participants at risk
Pre-identified presence of somatic or germline deleterious mutation, as determined by NGS only, in at least one gene critical to DNA repair through homologous recombination, including but not limited to: ARID1A, ATM, ATRX, MRE11A, NBN, PTEN, RAD50/51/51B, BARD1, BLM, BRCA1, BRCA2, BRIP1, FANCA/C/D2/E/F/G/L, PALB2, WRN, CHEK2, CHEK1, BAP1, FAM175A, SLX4, MLL2 or XRCC.
|
HR Proficient
n=4 participants at risk
No identifiable somatic or germline deleterious mutation in DNA Response and Repair pathway
|
|---|---|---|
|
General Disorders
Fever
|
0.00%
0/5 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
25.0%
1/4 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Blood and Lymphatic System Disorders
Anemia
|
40.0%
2/5 • Number of events 2 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
100.0%
4/4 • Number of events 5 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Blood and Lymphatic System Disorders
Blood and lymphatic system disorders - Other, specify
|
40.0%
2/5 • Number of events 2 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
50.0%
2/4 • Number of events 2 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Gastrointestinal Disorders
Abdominal pain
|
0.00%
0/5 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
50.0%
2/4 • Number of events 2 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Gastrointestinal Disorders
Constipation
|
60.0%
3/5 • Number of events 3 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
25.0%
1/4 • Number of events 2 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Gastrointestinal Disorders
Diarrhea
|
0.00%
0/5 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
50.0%
2/4 • Number of events 2 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Gastrointestinal Disorders
Dry mouth
|
20.0%
1/5 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
0.00%
0/4 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Gastrointestinal Disorders
Dysphagia
|
20.0%
1/5 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
25.0%
1/4 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Gastrointestinal Disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/5 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
50.0%
2/4 • Number of events 2 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Gastrointestinal Disorders
Nausea
|
100.0%
5/5 • Number of events 6 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
75.0%
3/4 • Number of events 4 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Gastrointestinal Disorders
Vomiting
|
0.00%
0/5 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
50.0%
2/4 • Number of events 2 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
General Disorders
Fatigue
|
40.0%
2/5 • Number of events 3 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
100.0%
4/4 • Number of events 4 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
General Disorders
General disorders and administration site conditions - Other, specify
|
20.0%
1/5 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
0.00%
0/4 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Investigations
Neutrophil count decreased
|
20.0%
1/5 • Number of events 2 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
0.00%
0/4 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Investigations
White blood cell decreased
|
40.0%
2/5 • Number of events 2 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
25.0%
1/4 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Metabolism and Nutrition Disorders
Anorexia
|
20.0%
1/5 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
0.00%
0/4 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Metabolism and Nutrition Disorders
Dehydration
|
0.00%
0/5 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
50.0%
2/4 • Number of events 2 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Metabolism and Nutrition Disorders
Hypokalemia
|
40.0%
2/5 • Number of events 2 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
0.00%
0/4 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Metabolism and Nutrition Disorders
Hyponatremia
|
20.0%
1/5 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
25.0%
1/4 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Metabolism and Nutrition Disorders
Hypophosphatemia
|
20.0%
1/5 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
0.00%
0/4 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Metabolism and Nutrition Disorders
Metabolism and nutrition disorders - Other, specify
|
0.00%
0/5 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
25.0%
1/4 • Number of events 2 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Metabolism and Nutrition Disorders
Weight loss
|
20.0%
1/5 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
0.00%
0/4 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Musculoskeletal and Connective Tissue Disorders
Bone pain
|
0.00%
0/5 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
25.0%
1/4 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Musculoskeletal and Connective Tissue Disorders
Myalgia
|
20.0%
1/5 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
0.00%
0/4 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Musculoskeletal and Connective Tissue Disorders
Neck pain
|
20.0%
1/5 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
0.00%
0/4 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Musculoskeletal and Connective Tissue Disorders
Pain in extremity
|
20.0%
1/5 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
25.0%
1/4 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Musculoskeletal and Connective Tissue Disorders
Pelvic pain
|
0.00%
0/5 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
25.0%
1/4 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Nervous System Disorders
Concentration impairment
|
20.0%
1/5 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
0.00%
0/4 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Nervous System Disorders
Headache
|
20.0%
1/5 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
0.00%
0/4 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Nervous System Disorders
Nervous system disorders - Other, specify
|
20.0%
1/5 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
50.0%
2/4 • Number of events 6 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Nervous System Disorders
Peripheral sensory neuropathy
|
0.00%
0/5 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
25.0%
1/4 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Nervous System Disorders
Presyncope
|
0.00%
0/5 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
25.0%
1/4 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Psychiatric Disorders
Insomnia
|
20.0%
1/5 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
25.0%
1/4 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Renal and Urinary Disorders
Dysuria
|
0.00%
0/5 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
25.0%
1/4 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Reproductive System and Breast Disorders
Penile pain
|
0.00%
0/5 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
25.0%
1/4 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Reproductive System and Breast Disorders
Reproductive system and breast disorders - Other, specify
|
0.00%
0/5 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
25.0%
1/4 • Number of events 2 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Reproductive System and Breast Disorders
Scrotal pain
|
0.00%
0/5 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
25.0%
1/4 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Reproductive System and Breast Disorders
Testicular pain
|
0.00%
0/5 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
25.0%
1/4 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Respiratory, Thoracic and Mediastinal Disorders
Cough
|
40.0%
2/5 • Number of events 2 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
25.0%
1/4 • Number of events 2 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Respiratory, Thoracic and Mediastinal Disorders
Pleural effusion
|
0.00%
0/5 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
25.0%
1/4 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Respiratory, Thoracic and Mediastinal Disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
20.0%
1/5 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
0.00%
0/4 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Skin and Subcutaneous Tissue Disorders
Hyperhidrosis
|
20.0%
1/5 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
0.00%
0/4 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Skin and Subcutaneous Tissue Disorders
Rash acneiform
|
20.0%
1/5 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
0.00%
0/4 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Skin and Subcutaneous Tissue Disorders
Rash maculo-papular
|
0.00%
0/5 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
25.0%
1/4 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
|
Social Circumstances
Social circumstances - Other, specify
|
0.00%
0/5 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
25.0%
1/4 • Number of events 2 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the participant initiates new anticancer therapy, up to 2 years total
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place