Trial Outcomes & Findings for Neoadjuvant Modified FOLFIRINOX and Stereotactic Body Radiation Therapy in Borderline Resectable Pancreatic Adenocarcinoma (NCT NCT03099265)
NCT ID: NCT03099265
Last Updated: 2022-10-27
Results Overview
The primary outcome of this study is the R0 resection count of patients with BRPC treated with neoadjuvant mFOLFIRINOX and SBRT. R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed. When the study results were entered, rate was replaced with count as the manner in which these data were summarized.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
Up to 40 weeks
Results posted on
2022-10-27
Participant Flow
Participant milestones
| Measure |
Patients With Borderline Resectable Pancreatic Adenocarcinoma
Borderline resectable disease will be defined by NCCN criteria, and determined centrally by review of a diagnostic pancreas protocol CT scan and/or MRI scan with contrast by a dedicated surgical oncologist and radiologist.
neoadjuvant mFOLFIRINOX: Patients will receive 8 cycles of mFOLFIRINOX every 2 weeks. mFOLFIRINOX will be dosed as follows: Oxaliplatin 85 mg/m2, followed by folinic acid 400 mg/m2 infused over 120 minutes and irinotecan 135 mg/m2 infused over 90 minutes, followed by 5-fluorouracil 300 mg/m2 IV bolus, followed by 2,400 mg/m2 continuous infusion for 46 hours. Levoleucovorin may be substituted for folinic acid at a dose of 200 mg/m2 infused over 120 minutes.
Stereotactic body radiotherapy (SBRT): Stereotactic body radiotherapy (SBRT) will be delivered to the primary tumor and any adjacent involved nodes to 33 Gy in 5 fractions over the course of 2 weeks, and within 4 weeks of chemotherapy.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
Per Protocol Week 12
|
8
|
|
Overall Study
Per Protocol Week 24
|
4
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Patients With Borderline Resectable Pancreatic Adenocarcinoma
Borderline resectable disease will be defined by NCCN criteria, and determined centrally by review of a diagnostic pancreas protocol CT scan and/or MRI scan with contrast by a dedicated surgical oncologist and radiologist.
neoadjuvant mFOLFIRINOX: Patients will receive 8 cycles of mFOLFIRINOX every 2 weeks. mFOLFIRINOX will be dosed as follows: Oxaliplatin 85 mg/m2, followed by folinic acid 400 mg/m2 infused over 120 minutes and irinotecan 135 mg/m2 infused over 90 minutes, followed by 5-fluorouracil 300 mg/m2 IV bolus, followed by 2,400 mg/m2 continuous infusion for 46 hours. Levoleucovorin may be substituted for folinic acid at a dose of 200 mg/m2 infused over 120 minutes.
Stereotactic body radiotherapy (SBRT): Stereotactic body radiotherapy (SBRT) will be delivered to the primary tumor and any adjacent involved nodes to 33 Gy in 5 fractions over the course of 2 weeks, and within 4 weeks of chemotherapy.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Neoadjuvant Modified FOLFIRINOX and Stereotactic Body Radiation Therapy in Borderline Resectable Pancreatic Adenocarcinoma
Baseline characteristics by cohort
| Measure |
Patients With Borderline Resectable Pancreatic Adenocarcinoma
n=9 Participants
Borderline resectable disease will be defined by NCCN criteria, and determined centrally by review of a diagnostic pancreas protocol CT scan and/or MRI scan with contrast by a dedicated surgical oncologist and radiologist.
neoadjuvant mFOLFIRINOX: Patients will receive 8 cycles of mFOLFIRINOX every 2 weeks. mFOLFIRINOX will be dosed as follows: Oxaliplatin 85 mg/m2, followed by folinic acid 400 mg/m2 infused over 120 minutes and irinotecan 135 mg/m2 infused over 90 minutes, followed by 5-fluorouracil 300 mg/m2 IV bolus, followed by 2,400 mg/m2 continuous infusion for 46 hours. Levoleucovorin may be substituted for folinic acid at a dose of 200 mg/m2 infused over 120 minutes.
Stereotactic body radiotherapy (SBRT): Stereotactic body radiotherapy (SBRT) will be delivered to the primary tumor and any adjacent involved nodes to 33 Gy in 5 fractions over the course of 2 weeks, and within 4 weeks of chemotherapy.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 40 weeksThe primary outcome of this study is the R0 resection count of patients with BRPC treated with neoadjuvant mFOLFIRINOX and SBRT. R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed. When the study results were entered, rate was replaced with count as the manner in which these data were summarized.
Outcome measures
| Measure |
Patients With Borderline Resectable Pancreatic Adenocarcinoma
n=9 Participants
Borderline resectable disease will be defined by NCCN criteria, and determined centrally by review of a diagnostic pancreas protocol CT scan and/or MRI scan with contrast by a dedicated surgical oncologist and radiologist.
neoadjuvant mFOLFIRINOX: Patients will receive 8 cycles of mFOLFIRINOX every 2 weeks. mFOLFIRINOX will be dosed as follows: Oxaliplatin 85 mg/m2, followed by folinic acid 400 mg/m2 infused over 120 minutes and irinotecan 135 mg/m2 infused over 90 minutes, followed by 5-fluorouracil 300 mg/m2 IV bolus, followed by 2,400 mg/m2 continuous infusion for 46 hours. Levoleucovorin may be substituted for folinic acid at a dose of 200 mg/m2 infused over 120 minutes.
Stereotactic body radiotherapy (SBRT): Stereotactic body radiotherapy (SBRT) will be delivered to the primary tumor and any adjacent involved nodes to 33 Gy in 5 fractions over the course of 2 weeks, and within 4 weeks of chemotherapy.
|
|---|---|
|
Number of Participants With and Without R0 Resection
Yes
|
2 Participants
|
|
Number of Participants With and Without R0 Resection
No
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to 40 weeksResponse to treatment will be assessed by the treating physicians and investigators according to RECIST version 1.1. Counts of participants' RECIST category at their final visit up to 40 weeks below are provided. Per Response Evaluation Criteria In Solid TumorsCriteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response(CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Patients With Borderline Resectable Pancreatic Adenocarcinoma
n=9 Participants
Borderline resectable disease will be defined by NCCN criteria, and determined centrally by review of a diagnostic pancreas protocol CT scan and/or MRI scan with contrast by a dedicated surgical oncologist and radiologist.
neoadjuvant mFOLFIRINOX: Patients will receive 8 cycles of mFOLFIRINOX every 2 weeks. mFOLFIRINOX will be dosed as follows: Oxaliplatin 85 mg/m2, followed by folinic acid 400 mg/m2 infused over 120 minutes and irinotecan 135 mg/m2 infused over 90 minutes, followed by 5-fluorouracil 300 mg/m2 IV bolus, followed by 2,400 mg/m2 continuous infusion for 46 hours. Levoleucovorin may be substituted for folinic acid at a dose of 200 mg/m2 infused over 120 minutes.
Stereotactic body radiotherapy (SBRT): Stereotactic body radiotherapy (SBRT) will be delivered to the primary tumor and any adjacent involved nodes to 33 Gy in 5 fractions over the course of 2 weeks, and within 4 weeks of chemotherapy.
|
|---|---|
|
Number of Participants Response to Neoadjuvant Therapy Using RECIST
stable disease (SD)
|
7 Participants
|
|
Number of Participants Response to Neoadjuvant Therapy Using RECIST
progressive disease (PD)
|
1 Participants
|
|
Number of Participants Response to Neoadjuvant Therapy Using RECIST
partial response (PR)
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 40 weeksPopulation: Only patients with R0 resection had pathologic response assesssed.
A pathologic complete response is defined as the absence of residual invasive disease at the completion of the neoadjuvant treatment. This was performed only in those that had R0 resection performed.
Outcome measures
| Measure |
Patients With Borderline Resectable Pancreatic Adenocarcinoma
n=2 Participants
Borderline resectable disease will be defined by NCCN criteria, and determined centrally by review of a diagnostic pancreas protocol CT scan and/or MRI scan with contrast by a dedicated surgical oncologist and radiologist.
neoadjuvant mFOLFIRINOX: Patients will receive 8 cycles of mFOLFIRINOX every 2 weeks. mFOLFIRINOX will be dosed as follows: Oxaliplatin 85 mg/m2, followed by folinic acid 400 mg/m2 infused over 120 minutes and irinotecan 135 mg/m2 infused over 90 minutes, followed by 5-fluorouracil 300 mg/m2 IV bolus, followed by 2,400 mg/m2 continuous infusion for 46 hours. Levoleucovorin may be substituted for folinic acid at a dose of 200 mg/m2 infused over 120 minutes.
Stereotactic body radiotherapy (SBRT): Stereotactic body radiotherapy (SBRT) will be delivered to the primary tumor and any adjacent involved nodes to 33 Gy in 5 fractions over the course of 2 weeks, and within 4 weeks of chemotherapy.
|
|---|---|
|
Number of Participants With and Without Pathologic Response to Neoadjuvant Therapy
Yes
|
0 Participants
|
|
Number of Participants With and Without Pathologic Response to Neoadjuvant Therapy
No
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 40 weeksPopulation: This population includes the 8 of 9 patients that experienced disease progression.
Number of participants with and without recurrence following surgery. This outcome was updated when the results were entered.
Outcome measures
| Measure |
Patients With Borderline Resectable Pancreatic Adenocarcinoma
n=8 Participants
Borderline resectable disease will be defined by NCCN criteria, and determined centrally by review of a diagnostic pancreas protocol CT scan and/or MRI scan with contrast by a dedicated surgical oncologist and radiologist.
neoadjuvant mFOLFIRINOX: Patients will receive 8 cycles of mFOLFIRINOX every 2 weeks. mFOLFIRINOX will be dosed as follows: Oxaliplatin 85 mg/m2, followed by folinic acid 400 mg/m2 infused over 120 minutes and irinotecan 135 mg/m2 infused over 90 minutes, followed by 5-fluorouracil 300 mg/m2 IV bolus, followed by 2,400 mg/m2 continuous infusion for 46 hours. Levoleucovorin may be substituted for folinic acid at a dose of 200 mg/m2 infused over 120 minutes.
Stereotactic body radiotherapy (SBRT): Stereotactic body radiotherapy (SBRT) will be delivered to the primary tumor and any adjacent involved nodes to 33 Gy in 5 fractions over the course of 2 weeks, and within 4 weeks of chemotherapy.
|
|---|---|
|
Number of Participants With and Without Recurrence
Local Progression
|
4 Participants
|
|
Number of Participants With and Without Recurrence
Metastatic Progression
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPresented are count of patients that had experienced either progression free survival or disease progression through the follow up period.
Outcome measures
| Measure |
Patients With Borderline Resectable Pancreatic Adenocarcinoma
n=9 Participants
Borderline resectable disease will be defined by NCCN criteria, and determined centrally by review of a diagnostic pancreas protocol CT scan and/or MRI scan with contrast by a dedicated surgical oncologist and radiologist.
neoadjuvant mFOLFIRINOX: Patients will receive 8 cycles of mFOLFIRINOX every 2 weeks. mFOLFIRINOX will be dosed as follows: Oxaliplatin 85 mg/m2, followed by folinic acid 400 mg/m2 infused over 120 minutes and irinotecan 135 mg/m2 infused over 90 minutes, followed by 5-fluorouracil 300 mg/m2 IV bolus, followed by 2,400 mg/m2 continuous infusion for 46 hours. Levoleucovorin may be substituted for folinic acid at a dose of 200 mg/m2 infused over 120 minutes.
Stereotactic body radiotherapy (SBRT): Stereotactic body radiotherapy (SBRT) will be delivered to the primary tumor and any adjacent involved nodes to 33 Gy in 5 fractions over the course of 2 weeks, and within 4 weeks of chemotherapy.
|
|---|---|
|
Number of Participants: Progression Free Survival
Progression Free Survival
|
1 Participants
|
|
Number of Participants: Progression Free Survival
Disease Progression
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPresented are counts of patients that we either deceased or not deceased at the end of the follow up period.
Outcome measures
| Measure |
Patients With Borderline Resectable Pancreatic Adenocarcinoma
n=9 Participants
Borderline resectable disease will be defined by NCCN criteria, and determined centrally by review of a diagnostic pancreas protocol CT scan and/or MRI scan with contrast by a dedicated surgical oncologist and radiologist.
neoadjuvant mFOLFIRINOX: Patients will receive 8 cycles of mFOLFIRINOX every 2 weeks. mFOLFIRINOX will be dosed as follows: Oxaliplatin 85 mg/m2, followed by folinic acid 400 mg/m2 infused over 120 minutes and irinotecan 135 mg/m2 infused over 90 minutes, followed by 5-fluorouracil 300 mg/m2 IV bolus, followed by 2,400 mg/m2 continuous infusion for 46 hours. Levoleucovorin may be substituted for folinic acid at a dose of 200 mg/m2 infused over 120 minutes.
Stereotactic body radiotherapy (SBRT): Stereotactic body radiotherapy (SBRT) will be delivered to the primary tumor and any adjacent involved nodes to 33 Gy in 5 fractions over the course of 2 weeks, and within 4 weeks of chemotherapy.
|
|---|---|
|
Number of Participants: Overall Survival
Deceased
|
6 Participants
|
|
Number of Participants: Overall Survival
Not Deceased
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 40 weeksTo determine rates of grade 3 or greater gastrointestinal toxicity, including acute toxicities occurring within 3 months of treatment, and late toxicities occurring over 3 months after completion of radiation. This outcome was clarified when results were entered. The number of patients that experienced at least 1 grade 3 (or greater) event are presented.
Outcome measures
| Measure |
Patients With Borderline Resectable Pancreatic Adenocarcinoma
n=9 Participants
Borderline resectable disease will be defined by NCCN criteria, and determined centrally by review of a diagnostic pancreas protocol CT scan and/or MRI scan with contrast by a dedicated surgical oncologist and radiologist.
neoadjuvant mFOLFIRINOX: Patients will receive 8 cycles of mFOLFIRINOX every 2 weeks. mFOLFIRINOX will be dosed as follows: Oxaliplatin 85 mg/m2, followed by folinic acid 400 mg/m2 infused over 120 minutes and irinotecan 135 mg/m2 infused over 90 minutes, followed by 5-fluorouracil 300 mg/m2 IV bolus, followed by 2,400 mg/m2 continuous infusion for 46 hours. Levoleucovorin may be substituted for folinic acid at a dose of 200 mg/m2 infused over 120 minutes.
Stereotactic body radiotherapy (SBRT): Stereotactic body radiotherapy (SBRT) will be delivered to the primary tumor and any adjacent involved nodes to 33 Gy in 5 fractions over the course of 2 weeks, and within 4 weeks of chemotherapy.
|
|---|---|
|
Grade 3 or Greater Acute and Late Gastrointestinal Toxicity
|
5 Participants
|
Adverse Events
Patients With Borderline Resectable Pancreatic Adenocarcinoma
Serious events: 6 serious events
Other events: 9 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Patients With Borderline Resectable Pancreatic Adenocarcinoma
n=9 participants at risk
Borderline resectable disease will be defined by NCCN criteria, and determined centrally by review of a diagnostic pancreas protocol CT scan and/or MRI scan with contrast by a dedicated surgical oncologist and radiologist.
neoadjuvant mFOLFIRINOX: Patients will receive 8 cycles of mFOLFIRINOX every 2 weeks. mFOLFIRINOX will be dosed as follows: Oxaliplatin 85 mg/m2, followed by folinic acid 400 mg/m2 infused over 120 minutes and irinotecan 135 mg/m2 infused over 90 minutes, followed by 5-fluorouracil 300 mg/m2 IV bolus, followed by 2,400 mg/m2 continuous infusion for 46 hours. Levoleucovorin may be substituted for folinic acid at a dose of 200 mg/m2 infused over 120 minutes.
Stereotactic body radiotherapy (SBRT): Stereotactic body radiotherapy (SBRT) will be delivered to the primary tumor and any adjacent involved nodes to 33 Gy in 5 fractions over the course of 2 weeks, and within 4 weeks of chemotherapy.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
|
Gastrointestinal disorders
Colitis
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
|
Gastrointestinal disorders
Gastric ulcer
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
|
Gastrointestinal disorders
Nausea
|
22.2%
2/9 • Number of events 2 • Up to 40 weeks
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
|
General disorders
Fever
|
22.2%
2/9 • Number of events 2 • Up to 40 weeks
|
|
General disorders
Malaise
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
|
Hepatobiliary disorders
Hepatobility disorders - Other, specify
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
|
Infections and infestations
Sepsis
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
|
Infections and infestations
Upper respiratory infection
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
|
Vascular disorders
Hypertension
|
11.1%
1/9 • Number of events 2 • Up to 40 weeks
|
|
Vascular disorders
Hypotension
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
Other adverse events
| Measure |
Patients With Borderline Resectable Pancreatic Adenocarcinoma
n=9 participants at risk
Borderline resectable disease will be defined by NCCN criteria, and determined centrally by review of a diagnostic pancreas protocol CT scan and/or MRI scan with contrast by a dedicated surgical oncologist and radiologist.
neoadjuvant mFOLFIRINOX: Patients will receive 8 cycles of mFOLFIRINOX every 2 weeks. mFOLFIRINOX will be dosed as follows: Oxaliplatin 85 mg/m2, followed by folinic acid 400 mg/m2 infused over 120 minutes and irinotecan 135 mg/m2 infused over 90 minutes, followed by 5-fluorouracil 300 mg/m2 IV bolus, followed by 2,400 mg/m2 continuous infusion for 46 hours. Levoleucovorin may be substituted for folinic acid at a dose of 200 mg/m2 infused over 120 minutes.
Stereotactic body radiotherapy (SBRT): Stereotactic body radiotherapy (SBRT) will be delivered to the primary tumor and any adjacent involved nodes to 33 Gy in 5 fractions over the course of 2 weeks, and within 4 weeks of chemotherapy.
|
|---|---|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
|
Endocrine disorders
Hyperthyroidism
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
77.8%
7/9 • Number of events 9 • Up to 40 weeks
|
|
Gastrointestinal disorders
Constipation
|
77.8%
7/9 • Number of events 9 • Up to 40 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
77.8%
7/9 • Number of events 19 • Up to 40 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
|
Gastrointestinal disorders
Flatulence
|
22.2%
2/9 • Number of events 3 • Up to 40 weeks
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
44.4%
4/9 • Number of events 5 • Up to 40 weeks
|
|
Gastrointestinal disorders
Hemorrhoids
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
|
Gastrointestinal disorders
Nausea
|
88.9%
8/9 • Number of events 12 • Up to 40 weeks
|
|
Gastrointestinal disorders
Pancreatitis
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • Number of events 4 • Up to 40 weeks
|
|
Gastrointestinal disorders
Oral dysesthesia
|
22.2%
2/9 • Number of events 3 • Up to 40 weeks
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
55.6%
5/9 • Number of events 6 • Up to 40 weeks
|
|
General disorders
Fatigue
|
100.0%
9/9 • Number of events 16 • Up to 40 weeks
|
|
General disorders
Gait disturbance
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
66.7%
6/9 • Number of events 10 • Up to 40 weeks
|
|
General disorders
Irritability
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
|
General disorders
Pain
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
|
General disorders
Edema limbs
|
33.3%
3/9 • Number of events 3 • Up to 40 weeks
|
|
General disorders
Infusion related reaction
|
44.4%
4/9 • Number of events 4 • Up to 40 weeks
|
|
General disorders
Non-cardiac chest pain
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
|
Vascular disorders
Hypertension
|
11.1%
1/9 • Number of events 2 • Up to 40 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
3/9 • Number of events 3 • Up to 40 weeks
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
22.2%
2/9 • Number of events 5 • Up to 40 weeks
|
|
Infections and infestations
Infections and infestations - Other, specify
|
22.2%
2/9 • Number of events 3 • Up to 40 weeks
|
|
Infections and infestations
Upper respiratory infection
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
|
Infections and infestations
Urinary tract infection
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
11.1%
1/9 • Number of events 2 • Up to 40 weeks
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
3/9 • Number of events 5 • Up to 40 weeks
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
3/9 • Number of events 6 • Up to 40 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
22.2%
2/9 • Number of events 6 • Up to 40 weeks
|
|
Investigations
Blood bilirubin increased
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
|
Investigations
Investigations - Other, specify
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
|
Investigations
Neutrophil count decreased
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
|
Investigations
Platelet count decreased
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
|
Investigations
Weight gain
|
11.1%
1/9 • Number of events 2 • Up to 40 weeks
|
|
Investigations
Weight loss
|
55.6%
5/9 • Number of events 11 • Up to 40 weeks
|
|
Investigations
White blood cell decreased
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
88.9%
8/9 • Number of events 11 • Up to 40 weeks
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
22.2%
2/9 • Number of events 3 • Up to 40 weeks
|
|
Metabolism and nutrition disorders
Hypokalemia
|
22.2%
2/9 • Number of events 2 • Up to 40 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
3/9 • Number of events 3 • Up to 40 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
11.1%
1/9 • Number of events 2 • Up to 40 weeks
|
|
Nervous system disorders
Amnesia
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
|
Nervous system disorders
Dizziness
|
22.2%
2/9 • Number of events 2 • Up to 40 weeks
|
|
Nervous system disorders
Dysarthria
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
|
Nervous system disorders
Dysgeusia
|
22.2%
2/9 • Number of events 2 • Up to 40 weeks
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
22.2%
2/9 • Number of events 4 • Up to 40 weeks
|
|
Nervous system disorders
Paresthesia
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
66.7%
6/9 • Number of events 7 • Up to 40 weeks
|
|
Nervous system disorders
Reversible posterior leukoencephalopathy syndrome
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
|
Psychiatric disorders
Anxiety
|
22.2%
2/9 • Number of events 2 • Up to 40 weeks
|
|
Psychiatric disorders
Depression
|
22.2%
2/9 • Number of events 2 • Up to 40 weeks
|
|
Psychiatric disorders
Insomnia
|
66.7%
6/9 • Number of events 6 • Up to 40 weeks
|
|
Cardiac disorders
Palpitations
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
22.2%
2/9 • Number of events 2 • Up to 40 weeks
|
|
Renal and urinary disorders
Urine discoloration
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
3/9 • Number of events 3 • Up to 40 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
22.2%
2/9 • Number of events 2 • Up to 40 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
11.1%
1/9 • Number of events 2 • Up to 40 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
3/9 • Number of events 4 • Up to 40 weeks
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
11.1%
1/9 • Number of events 1 • Up to 40 weeks
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
22.2%
2/9 • Number of events 2 • Up to 40 weeks
|
Additional Information
Kimberly L. Johung, MD, PhD Associate Professor of Therapeutic Radiology
Yale School of Medicine
Phone: (203) 200-2008
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place