Trial Outcomes & Findings for Trial of ICM With or Without AZD2281 (Olaparib) in Patients With Advanced Pancreatic Cancer (NCT NCT01296763)
NCT ID: NCT01296763
Last Updated: 2016-03-22
Results Overview
1.Phase I - Assess the safety and toxicities of IC with Olaparib escalating to ICM with Olaparib in patients with locally advanced and metastatic pancreatic cancer and determine the phase 2 dose. The number of subjects who experienced a dose limiting toxicity was assessed.Dose-limiting toxicity (DLT) is defined as any of the following study drug-related events experienced during Cycle 1: Thrombocytopenia with platelets \<25,000 x106/l \> 7 days. Grade 4 neutropenia lasting ≥7 days. Grade 3 or 4 febrile neutropenia. Grade 3 or greater non-haematological toxicities; excluding grade 3 diarrhoea, nausea or vomiting despite adequate treatment and grade 3 fatigue, lethargy and GGT elevation. Delay of \>2 weeks for next scheduled IC/ICM for reasons of toxicity.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
2 years
Results posted on
2016-03-22
Participant Flow
Participant milestones
| Measure |
Dose Level 1
1. Irinotecan 70 mg/m2 IV, Days 1 and 8
2. Cisplatin 25 mg/m2 IV, Days 1 and 8
3. Olaparib 100 mg bid oral, Days 1 and 8
|
Dose Level 2
1. Irinotecan 70 mg/m2 IV, Days 1 and 8
2. Cisplatin 25 mg/m2 IV, Days 1 and 8
3. Olaparib 100mg bid oral, Day 1-3, Day 8-10
|
Dose Level 5
1. Irinotecan 70 mg/m2 IV, Days 1 and 8
2. Cisplatin 25 mg/m2 IV, Days 1 and 8
3. Mitomycin 5 mg/m2 IV, Day 1
4. Olaparib 100 mg bid oral, Days 1 and 8
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
5
|
6
|
|
Overall Study
COMPLETED
|
7
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of ICM With or Without AZD2281 (Olaparib) in Patients With Advanced Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Dose Level 1
n=7 Participants
1. Irinotecan 70 mg/m2 IV, Days 1 and 8
2. Cisplatin 25 mg/m2 IV, Days 1 and 8
3. Olaparib 100 mg bid oral, Days 1 and 8
|
Dose Level 2
n=5 Participants
1. Irinotecan 70 mg/m2 IV, Days 1 and 8
2. Cisplatin 25 mg/m2 IV, Days 1 and 8
3. Olaparib 100mg bid oral, Day 1-3, Day 8-10
|
Dose Level 5
n=6 Participants
1. Irinotecan 70 mg/m2 IV, Days 1 and 8
2. Cisplatin 25 mg/m2 IV, Days 1 and 8
3. Mitomycin 5 mg/m2 IV, Day 1
4. Olaparib 100 mg bid oral, Days 1 and 8
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Age, Continuous
|
59.28 years
n=5 Participants
|
59.08 years
n=7 Participants
|
51.98 years
n=5 Participants
|
56.79 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
6 participants
n=5 Participants
|
18 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Number of subjects who experienced a dose limiting toxicity, as defined in the protocol.
1.Phase I - Assess the safety and toxicities of IC with Olaparib escalating to ICM with Olaparib in patients with locally advanced and metastatic pancreatic cancer and determine the phase 2 dose. The number of subjects who experienced a dose limiting toxicity was assessed.Dose-limiting toxicity (DLT) is defined as any of the following study drug-related events experienced during Cycle 1: Thrombocytopenia with platelets \<25,000 x106/l \> 7 days. Grade 4 neutropenia lasting ≥7 days. Grade 3 or 4 febrile neutropenia. Grade 3 or greater non-haematological toxicities; excluding grade 3 diarrhoea, nausea or vomiting despite adequate treatment and grade 3 fatigue, lethargy and GGT elevation. Delay of \>2 weeks for next scheduled IC/ICM for reasons of toxicity.
Outcome measures
| Measure |
Dose Level 1
n=7 Participants
1. Irinotecan 70 mg/m2 IV, Days 1 and 8
2. Cisplatin 25 mg/m2 IV, Days 1 and 8
3. Olaparib 100 mg bid oral, Days 1 and 8
|
Dose Level 2
n=5 Participants
1. Irinotecan 70 mg/m2 IV, Days 1 and 8
2. Cisplatin 25 mg/m2 IV, Days 1 and 8
3. Olaparib 100mg bid oral, Day 1-3, Day 8-10
|
Dose Level 5
n=6 Participants
1. Irinotecan 70 mg/m2 IV, Days 1 and 8
2. Cisplatin 25 mg/m2 IV, Days 1 and 8
3. Mitomycin 5 mg/m2 IV, Day 1
4. Olaparib 100 mg bid oral, Days 1 and 8
|
|---|---|---|---|
|
Number of Participants Who Experienced a Dose Limiting Toxicity to Determine the Maximum Tolerated Dose (MTD)
|
0 participants
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 5 yearsThe overall survival of subjects with locally advanced and/or metastatic pancreatic cancer treated with Irinotecan, Cisplatin, Olaparib, with escalation to the addition of Mitomycin-C. Survival from cycle 1, day 1 on-study to date of death was assessed.
Outcome measures
| Measure |
Dose Level 1
n=7 Participants
1. Irinotecan 70 mg/m2 IV, Days 1 and 8
2. Cisplatin 25 mg/m2 IV, Days 1 and 8
3. Olaparib 100 mg bid oral, Days 1 and 8
|
Dose Level 2
n=5 Participants
1. Irinotecan 70 mg/m2 IV, Days 1 and 8
2. Cisplatin 25 mg/m2 IV, Days 1 and 8
3. Olaparib 100mg bid oral, Day 1-3, Day 8-10
|
Dose Level 5
n=6 Participants
1. Irinotecan 70 mg/m2 IV, Days 1 and 8
2. Cisplatin 25 mg/m2 IV, Days 1 and 8
3. Mitomycin 5 mg/m2 IV, Day 1
4. Olaparib 100 mg bid oral, Days 1 and 8
|
|---|---|---|---|
|
Number of Years From Cycle 1, Day 1 On-Study to Date of Death
|
1.43 years (survival) from C1D1 to death
Interval 0.06 to 4.46
|
0.44 years (survival) from C1D1 to death
Interval 0.08 to 1.03
|
0.60 years (survival) from C1D1 to death
Interval 0.13 to 1.58
|
Adverse Events
Dose Level 1
Serious events: 5 serious events
Other events: 7 other events
Deaths: 0 deaths
Dose Level 2
Serious events: 4 serious events
Other events: 5 other events
Deaths: 0 deaths
Dose Level 5
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Level 1
n=7 participants at risk
1. Irinotecan 70 mg/m2 IV, Days 1 and 8
2. Cisplatin 25 mg/m2 IV, Days 1 and 8
3. Olaparib 100 mg bid oral, Days 1 and 8
|
Dose Level 2
n=5 participants at risk
1. Irinotecan 70 mg/m2 IV, Days 1 and 8
2. Cisplatin 25 mg/m2 IV, Days 1 and 8
3. Olaparib 100mg bid oral, Day 1-3, Day 8-10
|
Dose Level 5
n=6 participants at risk
1. Irinotecan 70 mg/m2 IV, Days 1 and 8
2. Cisplatin 25 mg/m2 IV, Days 1 and 8
3. Mitomycin 5 mg/m2 IV, Day 1
4. Olaparib 100 mg bid oral, Days 1 and 8
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Myelodysplastic syndrome
|
28.6%
2/7 • Number of events 2 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
28.6%
2/7 • Number of events 2 • up to 30 days after end of study visit.
|
20.0%
1/5 • Number of events 1 • up to 30 days after end of study visit.
|
16.7%
1/6 • Number of events 1 • up to 30 days after end of study visit.
|
|
Blood and lymphatic system disorders
Epistaxis
|
0.00%
0/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
16.7%
1/6 • Number of events 1 • up to 30 days after end of study visit.
|
|
Gastrointestinal disorders
Hematemesis
|
0.00%
0/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
16.7%
1/6 • Number of events 1 • up to 30 days after end of study visit.
|
|
Gastrointestinal disorders
hemorrhagic gastritis
|
14.3%
1/7 • Number of events 1 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Gastrointestinal disorders
colonic obstruction
|
14.3%
1/7 • Number of events 1 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Gastrointestinal disorders
prolapsed colostomy
|
0.00%
0/7 • up to 30 days after end of study visit.
|
20.0%
1/5 • Number of events 1 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Blood and lymphatic system disorders
anemia
|
0.00%
0/7 • up to 30 days after end of study visit.
|
20.0%
1/5 • Number of events 1 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/7 • up to 30 days after end of study visit.
|
20.0%
1/5 • Number of events 1 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Gastrointestinal disorders
ileus
|
0.00%
0/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
16.7%
1/6 • Number of events 1 • up to 30 days after end of study visit.
|
|
Cardiac disorders
atrial fibrilation
|
0.00%
0/7 • up to 30 days after end of study visit.
|
20.0%
1/5 • Number of events 1 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Cardiac disorders
right fronto-temporal subdural hematoma
|
0.00%
0/7 • up to 30 days after end of study visit.
|
20.0%
1/5 • Number of events 1 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
Other adverse events
| Measure |
Dose Level 1
n=7 participants at risk
1. Irinotecan 70 mg/m2 IV, Days 1 and 8
2. Cisplatin 25 mg/m2 IV, Days 1 and 8
3. Olaparib 100 mg bid oral, Days 1 and 8
|
Dose Level 2
n=5 participants at risk
1. Irinotecan 70 mg/m2 IV, Days 1 and 8
2. Cisplatin 25 mg/m2 IV, Days 1 and 8
3. Olaparib 100mg bid oral, Day 1-3, Day 8-10
|
Dose Level 5
n=6 participants at risk
1. Irinotecan 70 mg/m2 IV, Days 1 and 8
2. Cisplatin 25 mg/m2 IV, Days 1 and 8
3. Mitomycin 5 mg/m2 IV, Day 1
4. Olaparib 100 mg bid oral, Days 1 and 8
|
|---|---|---|---|
|
Gastrointestinal disorders
abdominal ascites
|
14.3%
1/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
16.7%
1/6 • up to 30 days after end of study visit.
|
|
Gastrointestinal disorders
abdominal cramps
|
0.00%
0/7 • up to 30 days after end of study visit.
|
20.0%
1/5 • up to 30 days after end of study visit.
|
16.7%
1/6 • up to 30 days after end of study visit.
|
|
Gastrointestinal disorders
abdominal distention
|
14.3%
1/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
16.7%
1/6 • up to 30 days after end of study visit.
|
|
Gastrointestinal disorders
abdominal pain
|
14.3%
1/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Renal and urinary disorders
acute kidney injury
|
14.3%
1/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Investigations
alk phos increased
|
42.9%
3/7 • up to 30 days after end of study visit.
|
40.0%
2/5 • up to 30 days after end of study visit.
|
50.0%
3/6 • up to 30 days after end of study visit.
|
|
Skin and subcutaneous tissue disorders
alopecia
|
14.3%
1/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
66.7%
4/6 • up to 30 days after end of study visit.
|
|
Investigations
ALT increased
|
42.9%
3/7 • up to 30 days after end of study visit.
|
40.0%
2/5 • up to 30 days after end of study visit.
|
50.0%
3/6 • up to 30 days after end of study visit.
|
|
Blood and lymphatic system disorders
anemia
|
100.0%
7/7 • up to 30 days after end of study visit.
|
60.0%
3/5 • up to 30 days after end of study visit.
|
83.3%
5/6 • up to 30 days after end of study visit.
|
|
Metabolism and nutrition disorders
anorexia
|
57.1%
4/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
50.0%
3/6 • up to 30 days after end of study visit.
|
|
Gastrointestinal disorders
anticipatory nausea
|
14.3%
1/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Psychiatric disorders
anxiety
|
14.3%
1/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Investigations
AST increased
|
28.6%
2/7 • up to 30 days after end of study visit.
|
40.0%
2/5 • up to 30 days after end of study visit.
|
50.0%
3/6 • up to 30 days after end of study visit.
|
|
General disorders
asthenia
|
0.00%
0/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
33.3%
2/6 • up to 30 days after end of study visit.
|
|
Cardiac disorders
atrial fibrillation
|
0.00%
0/7 • up to 30 days after end of study visit.
|
20.0%
1/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Cardiac disorders
atrial tachycardia
|
0.00%
0/7 • up to 30 days after end of study visit.
|
20.0%
1/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.00%
0/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
16.7%
1/6 • up to 30 days after end of study visit.
|
|
Investigations
bilirubin increased
|
14.3%
1/7 • up to 30 days after end of study visit.
|
40.0%
2/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Gastrointestinal disorders
bloody stools
|
14.3%
1/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Eye disorders
blurry vision
|
0.00%
0/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
16.7%
1/6 • up to 30 days after end of study visit.
|
|
Eye disorders
dry eyes
|
0.00%
0/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
16.7%
1/6 • up to 30 days after end of study visit.
|
|
Skin and subcutaneous tissue disorders
bruising around port
|
0.00%
0/7 • up to 30 days after end of study visit.
|
20.0%
1/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
General disorders
chest pain
|
14.3%
1/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
16.7%
1/6 • up to 30 days after end of study visit.
|
|
General disorders
chills
|
42.9%
3/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Ear and labyrinth disorders
clogged ear
|
0.00%
0/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
16.7%
1/6 • up to 30 days after end of study visit.
|
|
Psychiatric disorders
confusion
|
0.00%
0/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
16.7%
1/6 • up to 30 days after end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
congestion
|
0.00%
0/7 • up to 30 days after end of study visit.
|
20.0%
1/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Gastrointestinal disorders
constipation
|
14.3%
1/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
16.7%
1/6 • up to 30 days after end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
14.3%
1/7 • up to 30 days after end of study visit.
|
20.0%
1/5 • up to 30 days after end of study visit.
|
33.3%
2/6 • up to 30 days after end of study visit.
|
|
Investigations
creatinine increased
|
42.9%
3/7 • up to 30 days after end of study visit.
|
40.0%
2/5 • up to 30 days after end of study visit.
|
33.3%
2/6 • up to 30 days after end of study visit.
|
|
Metabolism and nutrition disorders
dehydration
|
14.3%
1/7 • up to 30 days after end of study visit.
|
20.0%
1/5 • up to 30 days after end of study visit.
|
33.3%
2/6 • up to 30 days after end of study visit.
|
|
Psychiatric disorders
depression
|
0.00%
0/7 • up to 30 days after end of study visit.
|
20.0%
1/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Gastrointestinal disorders
diarrhea
|
42.9%
3/7 • up to 30 days after end of study visit.
|
60.0%
3/5 • up to 30 days after end of study visit.
|
33.3%
2/6 • up to 30 days after end of study visit.
|
|
Gastrointestinal disorders
difficulty swallowing
|
14.3%
1/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
16.7%
1/6 • up to 30 days after end of study visit.
|
|
Renal and urinary disorders
difficulty urinating
|
14.3%
1/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Nervous system disorders
dizziness
|
0.00%
0/7 • up to 30 days after end of study visit.
|
20.0%
1/5 • up to 30 days after end of study visit.
|
16.7%
1/6 • up to 30 days after end of study visit.
|
|
Gastrointestinal disorders
dry mouth
|
14.3%
1/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Skin and subcutaneous tissue disorders
dry skin
|
0.00%
0/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
16.7%
1/6 • up to 30 days after end of study visit.
|
|
Nervous system disorders
dysgeusia
|
0.00%
0/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
33.3%
2/6 • up to 30 days after end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
42.9%
3/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
16.7%
1/6 • up to 30 days after end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea on exertion
|
14.3%
1/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
50.0%
3/6 • up to 30 days after end of study visit.
|
|
General disorders
edema
|
28.6%
2/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
16.7%
1/6 • up to 30 days after end of study visit.
|
|
General disorders
fatigue
|
71.4%
5/7 • up to 30 days after end of study visit.
|
40.0%
2/5 • up to 30 days after end of study visit.
|
66.7%
4/6 • up to 30 days after end of study visit.
|
|
General disorders
fever
|
42.9%
3/7 • up to 30 days after end of study visit.
|
40.0%
2/5 • up to 30 days after end of study visit.
|
16.7%
1/6 • up to 30 days after end of study visit.
|
|
Vascular disorders
flushing
|
0.00%
0/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
33.3%
2/6 • up to 30 days after end of study visit.
|
|
Gastrointestinal disorders
gastritis
|
14.3%
1/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Gastrointestinal disorders
gastrointestinal pain
|
14.3%
1/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
green mucous (nose)
|
0.00%
0/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
16.7%
1/6 • up to 30 days after end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
head cold with nasal congestion
|
14.3%
1/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Nervous system disorders
headache
|
0.00%
0/7 • up to 30 days after end of study visit.
|
20.0%
1/5 • up to 30 days after end of study visit.
|
16.7%
1/6 • up to 30 days after end of study visit.
|
|
Cardiac disorders
heart palpitations
|
14.3%
1/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Gastrointestinal disorders
heartburn
|
14.3%
1/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
33.3%
2/6 • up to 30 days after end of study visit.
|
|
Gastrointestinal disorders
hematemesis
|
14.3%
1/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Gastrointestinal disorders
hemorrhoids
|
0.00%
0/7 • up to 30 days after end of study visit.
|
20.0%
1/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
hiccups
|
28.6%
2/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
16.7%
1/6 • up to 30 days after end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
hoarseness (int)
|
0.00%
0/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
16.7%
1/6 • up to 30 days after end of study visit.
|
|
Metabolism and nutrition disorders
hyperglycemia
|
71.4%
5/7 • up to 30 days after end of study visit.
|
80.0%
4/5 • up to 30 days after end of study visit.
|
66.7%
4/6 • up to 30 days after end of study visit.
|
|
Metabolism and nutrition disorders
hyperkalemia
|
14.3%
1/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Metabolism and nutrition disorders
hyperphosphatemia
|
28.6%
2/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Metabolism and nutrition disorders
hypoalbuminemia
|
57.1%
4/7 • up to 30 days after end of study visit.
|
60.0%
3/5 • up to 30 days after end of study visit.
|
33.3%
2/6 • up to 30 days after end of study visit.
|
|
Metabolism and nutrition disorders
hypocalcemia
|
42.9%
3/7 • up to 30 days after end of study visit.
|
60.0%
3/5 • up to 30 days after end of study visit.
|
50.0%
3/6 • up to 30 days after end of study visit.
|
|
Metabolism and nutrition disorders
hypoglycemia (low)
|
0.00%
0/7 • up to 30 days after end of study visit.
|
20.0%
1/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Metabolism and nutrition disorders
hypokalemia
|
42.9%
3/7 • up to 30 days after end of study visit.
|
60.0%
3/5 • up to 30 days after end of study visit.
|
66.7%
4/6 • up to 30 days after end of study visit.
|
|
Metabolism and nutrition disorders
hypomagnesemia
|
28.6%
2/7 • up to 30 days after end of study visit.
|
60.0%
3/5 • up to 30 days after end of study visit.
|
16.7%
1/6 • up to 30 days after end of study visit.
|
|
Metabolism and nutrition disorders
hyponatremia
|
28.6%
2/7 • up to 30 days after end of study visit.
|
40.0%
2/5 • up to 30 days after end of study visit.
|
50.0%
3/6 • up to 30 days after end of study visit.
|
|
Metabolism and nutrition disorders
hypophosphatemia
|
14.3%
1/7 • up to 30 days after end of study visit.
|
20.0%
1/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Vascular disorders
hypotension
|
14.3%
1/7 • up to 30 days after end of study visit.
|
20.0%
1/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Gastrointestinal disorders
incontinent of stool
|
14.3%
1/7 • up to 30 days after end of study visit.
|
20.0%
1/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Renal and urinary disorders
increased urination (including at night) (intermittent)
|
14.3%
1/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Infections and infestations
infection (cold symptoms)
|
0.00%
0/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
16.7%
1/6 • up to 30 days after end of study visit.
|
|
Psychiatric disorders
insomnia
|
14.3%
1/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
16.7%
1/6 • up to 30 days after end of study visit.
|
|
Skin and subcutaneous tissue disorders
itching skin
|
14.3%
1/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Skin and subcutaneous tissue disorders
jaundice
|
0.00%
0/7 • up to 30 days after end of study visit.
|
20.0%
1/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Musculoskeletal and connective tissue disorders
knee pain
|
0.00%
0/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
16.7%
1/6 • up to 30 days after end of study visit.
|
|
Investigations
lymphocytes decreased
|
100.0%
7/7 • up to 30 days after end of study visit.
|
60.0%
3/5 • up to 30 days after end of study visit.
|
100.0%
6/6 • up to 30 days after end of study visit.
|
|
Nervous system disorders
memory impairment (intermittent)
|
0.00%
0/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
16.7%
1/6 • up to 30 days after end of study visit.
|
|
Gastrointestinal disorders
mucositis
|
0.00%
0/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
16.7%
1/6 • up to 30 days after end of study visit.
|
|
Musculoskeletal and connective tissue disorders
muscle aches
|
0.00%
0/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
33.3%
2/6 • up to 30 days after end of study visit.
|
|
Gastrointestinal disorders
nausea
|
57.1%
4/7 • up to 30 days after end of study visit.
|
60.0%
3/5 • up to 30 days after end of study visit.
|
83.3%
5/6 • up to 30 days after end of study visit.
|
|
Nervous system disorders
neuropathies
|
14.3%
1/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
33.3%
2/6 • up to 30 days after end of study visit.
|
|
Investigations
neutrophils decreased
|
100.0%
7/7 • up to 30 days after end of study visit.
|
60.0%
3/5 • up to 30 days after end of study visit.
|
100.0%
6/6 • up to 30 days after end of study visit.
|
|
Skin and subcutaneous tissue disorders
night sweats
|
14.3%
1/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Renal and urinary disorders
nocturia
|
14.3%
1/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
nose bleed (epistaxis)
|
0.00%
0/7 • up to 30 days after end of study visit.
|
20.0%
1/5 • up to 30 days after end of study visit.
|
16.7%
1/6 • up to 30 days after end of study visit.
|
|
Ear and labyrinth disorders
otitis media
|
0.00%
0/7 • up to 30 days after end of study visit.
|
20.0%
1/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Musculoskeletal and connective tissue disorders
pain in groin
|
28.6%
2/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Investigations
platelets decreased
|
85.7%
6/7 • up to 30 days after end of study visit.
|
80.0%
4/5 • up to 30 days after end of study visit.
|
100.0%
6/6 • up to 30 days after end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
post nasal drip
|
14.3%
1/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Musculoskeletal and connective tissue disorders
pressure in sternal area
|
0.00%
0/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
16.7%
1/6 • up to 30 days after end of study visit.
|
|
Skin and subcutaneous tissue disorders
pruritis
|
0.00%
0/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
33.3%
2/6 • up to 30 days after end of study visit.
|
|
Investigations
PT increased
|
0.00%
0/7 • up to 30 days after end of study visit.
|
60.0%
3/5 • up to 30 days after end of study visit.
|
33.3%
2/6 • up to 30 days after end of study visit.
|
|
Investigations
PTT increased
|
42.9%
3/7 • up to 30 days after end of study visit.
|
40.0%
2/5 • up to 30 days after end of study visit.
|
50.0%
3/6 • up to 30 days after end of study visit.
|
|
Skin and subcutaneous tissue disorders
rash
|
0.00%
0/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
16.7%
1/6 • up to 30 days after end of study visit.
|
|
Skin and subcutaneous tissue disorders
rash (left ear)
|
0.00%
0/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
16.7%
1/6 • up to 30 days after end of study visit.
|
|
Gastrointestinal disorders
rectal bleeding
|
14.3%
1/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Skin and subcutaneous tissue disorders
skin redness, swelling, right arm (shoulder to elbow)
|
0.00%
0/7 • up to 30 days after end of study visit.
|
20.0%
1/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
runny nose
|
14.3%
1/7 • up to 30 days after end of study visit.
|
20.0%
1/5 • up to 30 days after end of study visit.
|
16.7%
1/6 • up to 30 days after end of study visit.
|
|
Infections and infestations
sepsis
|
14.3%
1/7 • up to 30 days after end of study visit.
|
20.0%
1/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Infections and infestations
sore throat
|
0.00%
0/7 • up to 30 days after end of study visit.
|
20.0%
1/5 • up to 30 days after end of study visit.
|
16.7%
1/6 • up to 30 days after end of study visit.
|
|
Musculoskeletal and connective tissue disorders
stiffness in abdomen
|
14.3%
1/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Gastrointestinal disorders
stomach pain
|
0.00%
0/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
16.7%
1/6 • up to 30 days after end of study visit.
|
|
Gastrointestinal disorders
stomach virus recovery
|
14.3%
1/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Gastrointestinal disorders
stomatitis
|
0.00%
0/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
16.7%
1/6 • up to 30 days after end of study visit.
|
|
Gastrointestinal disorders
stool leakage
|
14.3%
1/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
stuffy nose
|
0.00%
0/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
16.7%
1/6 • up to 30 days after end of study visit.
|
|
Nervous system disorders
syncope
|
28.6%
2/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Eye disorders
tearing (watery eyes)
|
0.00%
0/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
33.3%
2/6 • up to 30 days after end of study visit.
|
|
Nervous system disorders
tremors
|
14.3%
1/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Infections and infestations
upper respiratory infection
|
14.3%
1/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Gastrointestinal disorders
vomiting
|
42.9%
3/7 • up to 30 days after end of study visit.
|
60.0%
3/5 • up to 30 days after end of study visit.
|
83.3%
5/6 • up to 30 days after end of study visit.
|
|
Investigations
WBC decreased
|
100.0%
7/7 • up to 30 days after end of study visit.
|
100.0%
5/5 • up to 30 days after end of study visit.
|
100.0%
6/6 • up to 30 days after end of study visit.
|
|
Musculoskeletal and connective tissue disorders
weakness
|
14.3%
1/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
0.00%
0/6 • up to 30 days after end of study visit.
|
|
Investigations
weight loss
|
28.6%
2/7 • up to 30 days after end of study visit.
|
0.00%
0/5 • up to 30 days after end of study visit.
|
16.7%
1/6 • up to 30 days after end of study visit.
|
Additional Information
Thomas Brown
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phone: 410-502-5328
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place