Trial Outcomes & Findings for Rational EpigenetiC Immunotherapy for SEcond Line Therapy in Patients With NSCLC: PRECISE Trial (NCT NCT02664181)
NCT ID: NCT02664181
Last Updated: 2024-09-03
Results Overview
Overall response rate (ORR) is defined as the proportion of all randomized subjects whose best overall response (BOR) from baseline is either a complete response (CR) or partial response (PR) per RECIST 1.1 criteria. BOR is determined by the best response designation recorded between the date of randomization and the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first. For subjects without documented progression or subsequent anticancer therapy, all available response designations will contribute to the BOR determination. For subjects who continue treatment beyond progression, the BOR should be determined based on response designations recorded at the time of the initial RECIST 1.1 defined progression.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
Up to 52 weeks after beginning therapy
Results posted on
2024-09-03
Participant Flow
Participant milestones
| Measure |
Oral THU/Decitabine + Nivolumab
Oral THU \~10 mg/kg, followed by oral decitabine \~0.2 mg/kg 60 minutes after the THU, twice weekly on consecutive days. This drug combination is administered with Nivolumab 3mg/kg IV Q2 weeks until progression
Nivolumab: Nivolumab will be given at 3mg/kg by IV every two weeks until progression
oral decitabine: oral decitabine \~0.2 mg/kg 60 minutes after the THU, twice weekly on consecutive days.
Tetrahydrouridine: Oral THU \~10 mg/kg twice weekly on consecutive days
|
Nivolumab
Nivolumab 3mg/kg IV Q2 weeks until progression; This is the standard of care for patients with NSCLC who have progressed on prior chemotherapy.
Nivolumab: Nivolumab will be given at 3mg/kg by IV every two weeks until progression
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
5
|
|
Overall Study
COMPLETED
|
8
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rational EpigenetiC Immunotherapy for SEcond Line Therapy in Patients With NSCLC: PRECISE Trial
Baseline characteristics by cohort
| Measure |
Oral THU/Decitabine + Nivolumab
n=8 Participants
Oral THU \~10 mg/kg, followed by oral decitabine \~0.2 mg/kg 60 minutes after the THU, twice weekly on consecutive days. This drug combination is administered with Nivolumab 3mg/kg IV Q2 weeks until progression
Nivolumab: Nivolumab will be given at 3mg/kg by IV every two weeks until progression
oral decitabine: oral decitabine \~0.2 mg/kg 60 minutes after the THU, twice weekly on consecutive days.
Tetrahydrouridine: Oral THU \~10 mg/kg twice weekly on consecutive days
|
Nivolumab
n=5 Participants
Nivolumab 3mg/kg IV Q2 weeks until progression; This is the standard of care for patients with NSCLC who have progressed on prior chemotherapy.
Nivolumab: Nivolumab will be given at 3mg/kg by IV every two weeks until progression
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
years · 40-49
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Customized
years · 50-59
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Customized
years · 60-69
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Customized
years · 70-79
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Customized
years · 80-89
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
5 participants
n=7 Participants
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 52 weeks after beginning therapyPopulation: Participants enrolled in study
Overall response rate (ORR) is defined as the proportion of all randomized subjects whose best overall response (BOR) from baseline is either a complete response (CR) or partial response (PR) per RECIST 1.1 criteria. BOR is determined by the best response designation recorded between the date of randomization and the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first. For subjects without documented progression or subsequent anticancer therapy, all available response designations will contribute to the BOR determination. For subjects who continue treatment beyond progression, the BOR should be determined based on response designations recorded at the time of the initial RECIST 1.1 defined progression.
Outcome measures
| Measure |
Nivolumab
n=5 Participants
Nivolumab 3mg/kg IV Q2 weeks until progression; This is the standard of care for patients with NSCLC who have progressed on prior chemotherapy.
Nivolumab: Nivolumab will be given at 3mg/kg by IV every two weeks until progression
|
Oral THU/Decitabine + Nivolumab
n=8 Participants
Oral THU \~10 mg/kg, followed by oral decitabine \~0.2 mg/kg 60 minutes after the THU, twice weekly on consecutive days. This drug combination is administered with Nivolumab 3mg/kg IV Q2 weeks until progression
Nivolumab: Nivolumab will be given at 3mg/kg by IV every two weeks until progression
oral decitabine: oral decitabine \~0.2 mg/kg 60 minutes after the THU, twice weekly on consecutive days.
Tetrahydrouridine: Oral THU \~10 mg/kg twice weekly on consecutive days
|
|---|---|---|
|
Objective Response by Response Evaluation Criteria in Solid Tumors (RECIST1.1)
Progressive disease
|
1 Participants
|
4 Participants
|
|
Objective Response by Response Evaluation Criteria in Solid Tumors (RECIST1.1)
Stable Disease
|
3 Participants
|
2 Participants
|
|
Objective Response by Response Evaluation Criteria in Solid Tumors (RECIST1.1)
Partial Remission
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 77 weeks after beginning treatmentPopulation: Participants enrolled in study
Time-to-Progression defined as the time from randomization to the date of the first documented tumor progression (per RECIST 1.1) or death due to any cause. Subjects who die without a reported prior progression will be considered to have progressed on the date of their death. Subjects who did not progress or die will be censored on the date of their last evaluable tumor assessment. Subjects who did not have any on study tumor assessments and did not die will be censored on the date they were randomized. Subjects who started any subsequent anti-cancer therapy without a prior reported progression will be censored at the last evaluable tumor assessment prior to initiation of the subsequent anti-cancer therapy. Progression will be assessed every 6 weeks (from the first on-study radiographic assessment) until disease progression is noted.
Outcome measures
| Measure |
Nivolumab
n=5 Participants
Nivolumab 3mg/kg IV Q2 weeks until progression; This is the standard of care for patients with NSCLC who have progressed on prior chemotherapy.
Nivolumab: Nivolumab will be given at 3mg/kg by IV every two weeks until progression
|
Oral THU/Decitabine + Nivolumab
n=8 Participants
Oral THU \~10 mg/kg, followed by oral decitabine \~0.2 mg/kg 60 minutes after the THU, twice weekly on consecutive days. This drug combination is administered with Nivolumab 3mg/kg IV Q2 weeks until progression
Nivolumab: Nivolumab will be given at 3mg/kg by IV every two weeks until progression
oral decitabine: oral decitabine \~0.2 mg/kg 60 minutes after the THU, twice weekly on consecutive days.
Tetrahydrouridine: Oral THU \~10 mg/kg twice weekly on consecutive days
|
|---|---|---|
|
Time-to-Progression
|
227 days
Interval 45.0 to 754.0
|
69 days
Interval 19.0 to 399.0
|
SECONDARY outcome
Timeframe: Up to 171 weeks after beginning treatmentPopulation: Participants enrolled in study
Overall survival: It is defined as the time from randomization to the date of death. A subject who has not died will be censored at last known date alive. Overall survival (OS) will be followed continuously while subjects are on the study drug.
Outcome measures
| Measure |
Nivolumab
n=5 Participants
Nivolumab 3mg/kg IV Q2 weeks until progression; This is the standard of care for patients with NSCLC who have progressed on prior chemotherapy.
Nivolumab: Nivolumab will be given at 3mg/kg by IV every two weeks until progression
|
Oral THU/Decitabine + Nivolumab
n=8 Participants
Oral THU \~10 mg/kg, followed by oral decitabine \~0.2 mg/kg 60 minutes after the THU, twice weekly on consecutive days. This drug combination is administered with Nivolumab 3mg/kg IV Q2 weeks until progression
Nivolumab: Nivolumab will be given at 3mg/kg by IV every two weeks until progression
oral decitabine: oral decitabine \~0.2 mg/kg 60 minutes after the THU, twice weekly on consecutive days.
Tetrahydrouridine: Oral THU \~10 mg/kg twice weekly on consecutive days
|
|---|---|---|
|
Overall Survival
|
844 Days
Interval 127.0 to 1183.0
|
389.5 Days
Interval 36.0 to 1147.0
|
SECONDARY outcome
Timeframe: Up to 5 years from end of treatmentPopulation: In the Nivolumab arm, 3 subjects did not meet the criteria for this outcome measure per protocol (received less than 12 doses). In the Oral THU/Decitabine + Nivolumab arm, 2 subjects id not meet the criteria for this outcome measure per protocol (received less than 12 doses).
Survival LTFU is planned to be done until death or withdrawal of consent, or until the final clinical trial report is published
Outcome measures
| Measure |
Nivolumab
n=2 Participants
Nivolumab 3mg/kg IV Q2 weeks until progression; This is the standard of care for patients with NSCLC who have progressed on prior chemotherapy.
Nivolumab: Nivolumab will be given at 3mg/kg by IV every two weeks until progression
|
Oral THU/Decitabine + Nivolumab
n=6 Participants
Oral THU \~10 mg/kg, followed by oral decitabine \~0.2 mg/kg 60 minutes after the THU, twice weekly on consecutive days. This drug combination is administered with Nivolumab 3mg/kg IV Q2 weeks until progression
Nivolumab: Nivolumab will be given at 3mg/kg by IV every two weeks until progression
oral decitabine: oral decitabine \~0.2 mg/kg 60 minutes after the THU, twice weekly on consecutive days.
Tetrahydrouridine: Oral THU \~10 mg/kg twice weekly on consecutive days
|
|---|---|---|
|
Overall Survival - Long Term Follow-up (LTFU)
|
5 months
Interval 3.0 to 7.0
|
6.8 months
Interval 1.0 to 17.0
|
Adverse Events
Oral THU/Decitabine + Nivolumab
Serious events: 4 serious events
Other events: 8 other events
Deaths: 6 deaths
Nivolumab
Serious events: 1 serious events
Other events: 5 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Oral THU/Decitabine + Nivolumab
n=8 participants at risk
Oral THU \~10 mg/kg, followed by oral decitabine \~0.2 mg/kg 60 minutes after the THU, twice weekly on consecutive days. This drug combination is administered with Nivolumab 3mg/kg IV Q2 weeks until progression
Nivolumab: Nivolumab will be given at 3mg/kg by IV every two weeks until progression
oral decitabine: oral decitabine \~0.2 mg/kg 60 minutes after the THU, twice weekly on consecutive days.
Tetrahydrouridine: Oral THU \~10 mg/kg twice weekly on consecutive days
|
Nivolumab
n=5 participants at risk
Nivolumab 3mg/kg IV Q2 weeks until progression; This is the standard of care for patients with NSCLC who have progressed on prior chemotherapy.
Nivolumab: Nivolumab will be given at 3mg/kg by IV every two weeks until progression
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease exacerbation
|
0.00%
0/8 • Adverse events were collected while the participants were on treatment for up to 20 months
|
20.0%
1/5 • Number of events 1 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Metabolism and nutrition disorders
dehydration
|
12.5%
1/8 • Number of events 2 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Number of events 1 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
1/8 • Number of events 1 • Adverse events were collected while the participants were on treatment for up to 20 months
|
20.0%
1/5 • Number of events 2 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
General disorders
Edema Limbs
|
0.00%
0/8 • Adverse events were collected while the participants were on treatment for up to 20 months
|
20.0%
1/5 • Number of events 1 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
12.5%
1/8 • Number of events 1 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
General disorders
Fever
|
12.5%
1/8 • Number of events 1 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Vascular disorders
Hypotension
|
12.5%
1/8 • Number of events 1 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
12.5%
1/8 • Number of events 1 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Number of events 1 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Investigations
Neutrophil count decreased
|
25.0%
2/8 • Number of events 5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Cardiac disorders
Pericardial effusion
|
12.5%
1/8 • Number of events 1 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
12.5%
1/8 • Number of events 1 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Infections and infestations
Sepsis
|
12.5%
1/8 • Number of events 1 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Cardiac disorders
supraventricular tachycardia
|
12.5%
1/8 • Number of events 2 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Number of events 1 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Investigations
White blood cell decreased
|
12.5%
1/8 • Number of events 3 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
Other adverse events
| Measure |
Oral THU/Decitabine + Nivolumab
n=8 participants at risk
Oral THU \~10 mg/kg, followed by oral decitabine \~0.2 mg/kg 60 minutes after the THU, twice weekly on consecutive days. This drug combination is administered with Nivolumab 3mg/kg IV Q2 weeks until progression
Nivolumab: Nivolumab will be given at 3mg/kg by IV every two weeks until progression
oral decitabine: oral decitabine \~0.2 mg/kg 60 minutes after the THU, twice weekly on consecutive days.
Tetrahydrouridine: Oral THU \~10 mg/kg twice weekly on consecutive days
|
Nivolumab
n=5 participants at risk
Nivolumab 3mg/kg IV Q2 weeks until progression; This is the standard of care for patients with NSCLC who have progressed on prior chemotherapy.
Nivolumab: Nivolumab will be given at 3mg/kg by IV every two weeks until progression
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8 • Number of events 14 • Adverse events were collected while the participants were on treatment for up to 20 months
|
20.0%
1/5 • Number of events 8 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Investigations
Absolute lymphocyte decrease
|
12.5%
1/8 • Number of events 5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Investigations
Absolute neutrophil decrease
|
12.5%
1/8 • Number of events 3 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Investigations
akathisa
|
12.5%
1/8 • Number of events 2 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Investigations
Alanine aminotransferase elevated
|
12.5%
1/8 • Number of events 2 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Investigations
alanine aminotransferase increased
|
12.5%
1/8 • Number of events 1 • Adverse events were collected while the participants were on treatment for up to 20 months
|
20.0%
1/5 • Number of events 6 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Investigations
Alkaline phosphatase increased
|
37.5%
3/8 • Number of events 9 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Investigations
ALT increased- due to prednisone
|
12.5%
1/8 • Number of events 4 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Blood and lymphatic system disorders
anemia
|
75.0%
6/8 • Number of events 63 • Adverse events were collected while the participants were on treatment for up to 20 months
|
40.0%
2/5 • Number of events 194 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Metabolism and nutrition disorders
anorexia
|
37.5%
3/8 • Number of events 5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
20.0%
1/5 • Number of events 3 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
2/8 • Number of events 17 • Adverse events were collected while the participants were on treatment for up to 20 months
|
20.0%
1/5 • Number of events 6 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Investigations
Aspartate aminotransferase elevated
|
12.5%
1/8 • Number of events 2 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Investigations
Aspartate aminotransferase increased
|
12.5%
1/8 • Number of events 2 • Adverse events were collected while the participants were on treatment for up to 20 months
|
40.0%
2/5 • Number of events 14 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Investigations
Aspartate phosphate increased
|
0.00%
0/8 • Adverse events were collected while the participants were on treatment for up to 20 months
|
20.0%
1/5 • Number of events 4 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Investigations
AST increased- due to prednisone
|
12.5%
1/8 • Number of events 4 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
General disorders
Back & Joint Cramp
|
0.00%
0/8 • Adverse events were collected while the participants were on treatment for up to 20 months
|
20.0%
1/5 • Number of events 1 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
General disorders
Back/Shoulder pain
|
0.00%
0/8 • Adverse events were collected while the participants were on treatment for up to 20 months
|
20.0%
1/5 • Number of events 1 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
General disorders
Bilateral hip pain
|
0.00%
0/8 • Adverse events were collected while the participants were on treatment for up to 20 months
|
20.0%
1/5 • Number of events 1 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
General disorders
Body ache
|
0.00%
0/8 • Adverse events were collected while the participants were on treatment for up to 20 months
|
20.0%
1/5 • Number of events 2 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
General disorders
BONE PAIN (left lateral rib)
|
0.00%
0/8 • Adverse events were collected while the participants were on treatment for up to 20 months
|
20.0%
1/5 • Number of events 1 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
General disorders
Chills
|
0.00%
0/8 • Adverse events were collected while the participants were on treatment for up to 20 months
|
20.0%
1/5 • Number of events 7 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
General disorders
Chronic Back Pain
|
0.00%
0/8 • Adverse events were collected while the participants were on treatment for up to 20 months
|
20.0%
1/5 • Number of events 1 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
General disorders
Cold
|
0.00%
0/8 • Adverse events were collected while the participants were on treatment for up to 20 months
|
20.0%
1/5 • Number of events 1 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
2/8 • Number of events 14 • Adverse events were collected while the participants were on treatment for up to 20 months
|
20.0%
1/5 • Number of events 4 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough/ drainage
|
0.00%
0/8 • Adverse events were collected while the participants were on treatment for up to 20 months
|
20.0%
1/5 • Number of events 1 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Investigations
Creatinine increased
|
0.00%
0/8 • Adverse events were collected while the participants were on treatment for up to 20 months
|
20.0%
1/5 • Number of events 8 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Metabolism and nutrition disorders
dehydration
|
12.5%
1/8 • Number of events 1 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
2/8 • Number of events 16 • Adverse events were collected while the participants were on treatment for up to 20 months
|
20.0%
1/5 • Number of events 6 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Nervous system disorders
Dizziness
|
25.0%
2/8 • Number of events 5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
20.0%
1/5 • Number of events 149 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.5%
1/8 • Number of events 7 • Adverse events were collected while the participants were on treatment for up to 20 months
|
20.0%
1/5 • Number of events 1 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
37.5%
3/8 • Number of events 7 • Adverse events were collected while the participants were on treatment for up to 20 months
|
20.0%
1/5 • Number of events 8 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Skin and subcutaneous tissue disorders
Edema
|
0.00%
0/8 • Adverse events were collected while the participants were on treatment for up to 20 months
|
20.0%
1/5 • Number of events 4 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
General disorders
Edema limbs
|
12.5%
1/8 • Number of events 1 • Adverse events were collected while the participants were on treatment for up to 20 months
|
40.0%
2/5 • Number of events 24 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
General disorders
Fatigue
|
0.00%
0/8 • Adverse events were collected while the participants were on treatment for up to 20 months
|
20.0%
1/5 • Number of events 1 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
12.5%
1/8 • Number of events 1 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
General disorders
Fever
|
12.5%
1/8 • Number of events 1 • Adverse events were collected while the participants were on treatment for up to 20 months
|
20.0%
1/5 • Number of events 6 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/8 • Adverse events were collected while the participants were on treatment for up to 20 months
|
20.0%
1/5 • Number of events 1 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Number of events 2 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Skin and subcutaneous tissue disorders
Hot & Cold sweats at night
|
0.00%
0/8 • Adverse events were collected while the participants were on treatment for up to 20 months
|
20.0%
1/5 • Number of events 1 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Metabolism and nutrition disorders
hypercalcemia
|
25.0%
2/8 • Number of events 25 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
12.5%
1/8 • Number of events 7 • Adverse events were collected while the participants were on treatment for up to 20 months
|
40.0%
2/5 • Number of events 19 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
37.5%
3/8 • Number of events 13 • Adverse events were collected while the participants were on treatment for up to 20 months
|
40.0%
2/5 • Number of events 18 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Metabolism and nutrition disorders
hypocalcemia
|
12.5%
1/8 • Number of events 1 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
12.5%
1/8 • Number of events 5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Metabolism and nutrition disorders
hyponatremia
|
25.0%
2/8 • Number of events 3 • Adverse events were collected while the participants were on treatment for up to 20 months
|
40.0%
2/5 • Number of events 3 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Vascular disorders
Hypotension
|
12.5%
1/8 • Number of events 1 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/8 • Adverse events were collected while the participants were on treatment for up to 20 months
|
20.0%
1/5 • Number of events 100 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
12.5%
1/8 • Number of events 1 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
General disorders
Knee & Ankle Pain
|
0.00%
0/8 • Adverse events were collected while the participants were on treatment for up to 20 months
|
20.0%
1/5 • Number of events 1 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Investigations
lymphocyte count decreased
|
37.5%
3/8 • Number of events 13 • Adverse events were collected while the participants were on treatment for up to 20 months
|
20.0%
1/5 • Number of events 1 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Infections and infestations
mucosal infection
|
12.5%
1/8 • Number of events 2 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
0.00%
0/8 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
12.5%
1/8 • Number of events 14 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal drip
|
0.00%
0/8 • Adverse events were collected while the participants were on treatment for up to 20 months
|
20.0%
1/5 • Number of events 1 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Gastrointestinal disorders
Nausea
|
25.0%
2/8 • Number of events 3 • Adverse events were collected while the participants were on treatment for up to 20 months
|
20.0%
1/5 • Number of events 3 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
General disorders
Neck Pain
|
0.00%
0/8 • Adverse events were collected while the participants were on treatment for up to 20 months
|
20.0%
1/5 • Number of events 1 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Investigations
neutrophil count decreased
|
37.5%
3/8 • Number of events 5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
General disorders
non-cardiac chest pain
|
12.5%
1/8 • Number of events 2 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
General disorders
pain (left rib)
|
12.5%
1/8 • Number of events 1 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
General disorders
pain in extremity (left arm)
|
0.00%
0/8 • Adverse events were collected while the participants were on treatment for up to 20 months
|
20.0%
1/5 • Number of events 18 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
General disorders
Pain, musculoskeletal, Left flank
|
0.00%
0/8 • Adverse events were collected while the participants were on treatment for up to 20 months
|
20.0%
1/5 • Number of events 6 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Infections and infestations
papulopustular rash
|
12.5%
1/8 • Number of events 15 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Skin and subcutaneous tissue disorders
periorbital edema
|
0.00%
0/8 • Adverse events were collected while the participants were on treatment for up to 20 months
|
20.0%
1/5 • Number of events 100 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/8 • Adverse events were collected while the participants were on treatment for up to 20 months
|
20.0%
1/5 • Number of events 1 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/8 • Adverse events were collected while the participants were on treatment for up to 20 months
|
20.0%
1/5 • Number of events 6 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
1/8 • Number of events 15 • Adverse events were collected while the participants were on treatment for up to 20 months
|
40.0%
2/5 • Number of events 3 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
12.5%
1/8 • Number of events 7 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
General disorders
Side Pain
|
0.00%
0/8 • Adverse events were collected while the participants were on treatment for up to 20 months
|
20.0%
1/5 • Number of events 1 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Infections and infestations
skin infection - fungal rash around urostomy
|
12.5%
1/8 • Number of events 4 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Nervous system disorders
spasticity - left elbow
|
12.5%
1/8 • Number of events 4 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Cardiac disorders
supraventricular tachycardia
|
12.5%
1/8 • Number of events 1 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Vascular disorders
Thromboembolic event
|
12.5%
1/8 • Number of events 2 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Ear and labyrinth disorders
tinnitus
|
0.00%
0/8 • Adverse events were collected while the participants were on treatment for up to 20 months
|
20.0%
1/5 • Number of events 156 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory Infection
|
0.00%
0/8 • Adverse events were collected while the participants were on treatment for up to 20 months
|
20.0%
1/5 • Number of events 1 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Number of events 2 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Metabolism and nutrition disorders
weight loss
|
12.5%
1/8 • Number of events 2 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Respiratory, thoracic and mediastinal disorders
wheezing
|
12.5%
1/8 • Number of events 7 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Investigations
White blood cell decreased
|
50.0%
4/8 • Number of events 18 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Nervous system disorders
worsening paraesthesia
|
12.5%
1/8 • Number of events 4 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
25.0%
2/8 • Number of events 3 • Adverse events were collected while the participants were on treatment for up to 20 months
|
0.00%
0/5 • Adverse events were collected while the participants were on treatment for up to 20 months
|
Additional Information
Dr. Nathan Pennell
Cleveland Clinic, Case Comprehensive Cancer Center
Phone: 1-866-223-8100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place