Trial Outcomes & Findings for Study of Hepatic Arterial Infusion With Intravenous Irinotecan, 5FU and Leucovorin With or Without Panitumumab, in Patients With Wild Type RAS Who Have Resected Hepatic Metastases From Colorectal Cancer (NCT NCT01312857)
NCT ID: NCT01312857
Last Updated: 2025-10-09
Results Overview
to determine if panitumumab with Hepatic Arterial Infusion (HAI) in combination with systemic chemotherapy can increase the recurrence free survival (RFS) for colorectal cancer patients with resected liver metastases
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
75 participants
Primary outcome timeframe
15 months
Results posted on
2025-10-09
Participant Flow
Participant milestones
| Measure |
Randomization to Panitumumab
Patients whose liver metastases have been completely resected will be randomized Arm A will receive Panitumumab in addition to HAI FUDR/Dexamethasone plus systemic CPT-11/5FU/LV
panitumumab: All patients receive HAI FUDR (0.12 mg/kg/day X kg X pump volume) / pump flow rate and Dexamethasone flat dose of 25 mg on days 1.
All patients receive CPT-11 (150 mg/m2 IV over 30 min to an hour), Leucovorin (400 mg/m2 IV, over 30 min to an hour) and 5FU (1000 mg/m2/day continuous infusion over two days) on days 15 and 29 Randomization to panitumumab 6 mg/kg day 15 and 29 Each cycle repeats every 36 days for a total of 6 cycles
|
Randomization to No Panitumumab
Patients whose liver metastases have been completely resected will be randomized and patients randomized to Arm B will receive HAI FUDR/Dex plus systemic CPT-11/5FU/LV alone.
Randomization to No Panitumumab: All patients receive HAI FUDR (0.12 mg/kg/day X kg X pump volume) / pump flow rate and Dexamethasone flat dose of 25 mg on days 1.
All patients receive CPT-11 (150 mg/m2 IV over 30 min to an hour), Leucovorin (400 mg/m2 IV, over 30 min to an hour) and 5FU (1000 mg/m2/day continuous infusion over two days) on days 15 and 29 Randomization (to no panitumumab) Each cycle repeats every 36 days for a total of 6 cycles
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
38
|
|
Overall Study
COMPLETED
|
29
|
37
|
|
Overall Study
NOT COMPLETED
|
8
|
1
|
Reasons for withdrawal
| Measure |
Randomization to Panitumumab
Patients whose liver metastases have been completely resected will be randomized Arm A will receive Panitumumab in addition to HAI FUDR/Dexamethasone plus systemic CPT-11/5FU/LV
panitumumab: All patients receive HAI FUDR (0.12 mg/kg/day X kg X pump volume) / pump flow rate and Dexamethasone flat dose of 25 mg on days 1.
All patients receive CPT-11 (150 mg/m2 IV over 30 min to an hour), Leucovorin (400 mg/m2 IV, over 30 min to an hour) and 5FU (1000 mg/m2/day continuous infusion over two days) on days 15 and 29 Randomization to panitumumab 6 mg/kg day 15 and 29 Each cycle repeats every 36 days for a total of 6 cycles
|
Randomization to No Panitumumab
Patients whose liver metastases have been completely resected will be randomized and patients randomized to Arm B will receive HAI FUDR/Dex plus systemic CPT-11/5FU/LV alone.
Randomization to No Panitumumab: All patients receive HAI FUDR (0.12 mg/kg/day X kg X pump volume) / pump flow rate and Dexamethasone flat dose of 25 mg on days 1.
All patients receive CPT-11 (150 mg/m2 IV over 30 min to an hour), Leucovorin (400 mg/m2 IV, over 30 min to an hour) and 5FU (1000 mg/m2/day continuous infusion over two days) on days 15 and 29 Randomization (to no panitumumab) Each cycle repeats every 36 days for a total of 6 cycles
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Physician Decision
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Study of Hepatic Arterial Infusion With Intravenous Irinotecan, 5FU and Leucovorin With or Without Panitumumab, in Patients With Wild Type RAS Who Have Resected Hepatic Metastases From Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Randomization to Panitumumab
n=37 Participants
Patients whose liver metastases have been completely resected will be randomized Arm A will receive Panitumumab in addition to HAI FUDR/Dexamethasone plus systemic CPT-11/5FU/LV
panitumumab: All patients receive HAI FUDR (0.12 mg/kg/day X kg X pump volume) / pump flow rate and Dexamethasone flat dose of 25 mg on days 1.
All patients receive CPT-11 (150 mg/m2 IV over 30 min to an hour), Leucovorin (400 mg/m2 IV, over 30 min to an hour) and 5FU (1000 mg/m2/day continuous infusion over two days) on days 15 and 29 Randomization to panitumumab 6 mg/kg day 15 and 29 Each cycle repeats every 36 days for a total of 6 cycles
|
Randomization to No Panitumumab
n=38 Participants
Patients whose liver metastases have been completely resected will be randomized and patients randomized to Arm B will receive HAI FUDR/Dex plus systemic CPT-11/5FU/LV alone.
Randomization to No Panitumumab: All patients receive HAI FUDR (0.12 mg/kg/day X kg X pump volume) / pump flow rate and Dexamethasone flat dose of 25 mg on days 1.
All patients receive CPT-11 (150 mg/m2 IV over 30 min to an hour), Leucovorin (400 mg/m2 IV, over 30 min to an hour) and 5FU (1000 mg/m2/day continuous infusion over two days) on days 15 and 29 Randomization (to no panitumumab) Each cycle repeats every 36 days for a total of 6 cycles
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52 years
n=5 Participants
|
53 years
n=7 Participants
|
53 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
68 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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 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
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
61 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
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
37 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 15 monthsto determine if panitumumab with Hepatic Arterial Infusion (HAI) in combination with systemic chemotherapy can increase the recurrence free survival (RFS) for colorectal cancer patients with resected liver metastases
Outcome measures
| Measure |
Randomization to Panitumumab
n=37 Participants
Patients whose liver metastases have been completely resected will be randomized Arm A will receive Panitumumab in addition to HAI FUDR/Dexamethasone plus systemic CPT-11/5FU/LV
panitumumab: All patients receive HAI FUDR (0.12 mg/kg/day X kg X pump volume) / pump flow rate and Dexamethasone flat dose of 25 mg on days 1.
All patients receive CPT-11 (150 mg/m2 IV over 30 min to an hour), Leucovorin (400 mg/m2 IV, over 30 min to an hour) and 5FU (1000 mg/m2/day continuous infusion over two days) on days 15 and 29 Randomization to panitumumab 6 mg/kg day 15 and 29 Each cycle repeats every 36 days for a total of 6 cycles
|
Randomization to No Panitumumab
n=38 Participants
Patients whose liver metastases have been completely resected will be randomized and patients randomized to Arm B will receive HAI FUDR/Dex plus systemic CPT-11/5FU/LV alone.
Randomization to No Panitumumab: All patients receive HAI FUDR (0.12 mg/kg/day X kg X pump volume) / pump flow rate and Dexamethasone flat dose of 25 mg on days 1.
All patients receive CPT-11 (150 mg/m2 IV over 30 min to an hour), Leucovorin (400 mg/m2 IV, over 30 min to an hour) and 5FU (1000 mg/m2/day continuous infusion over two days) on days 15 and 29 Randomization (to no panitumumab) Each cycle repeats every 36 days for a total of 6 cycles
|
|---|---|---|
|
Participants With Recurrence Free Survival for Colorectal Cancer Participants With Resected Liver Metastases
|
69 percentage of participants
Interval 53.0 to 82.0
|
47 percentage of participants
Interval 32.0 to 63.0
|
SECONDARY outcome
Timeframe: 2 yearsToxicities will be recorded as adverse events on the Adverse Event case report form and must be graded using The National Cancer Institute's Common Toxicity Criteria (CTC)version 4.0 with the exception of skin- or nail-related toxicities, which must be graded using CTC version 3.0 with modifications
Outcome measures
| Measure |
Randomization to Panitumumab
n=37 Participants
Patients whose liver metastases have been completely resected will be randomized Arm A will receive Panitumumab in addition to HAI FUDR/Dexamethasone plus systemic CPT-11/5FU/LV
panitumumab: All patients receive HAI FUDR (0.12 mg/kg/day X kg X pump volume) / pump flow rate and Dexamethasone flat dose of 25 mg on days 1.
All patients receive CPT-11 (150 mg/m2 IV over 30 min to an hour), Leucovorin (400 mg/m2 IV, over 30 min to an hour) and 5FU (1000 mg/m2/day continuous infusion over two days) on days 15 and 29 Randomization to panitumumab 6 mg/kg day 15 and 29 Each cycle repeats every 36 days for a total of 6 cycles
|
Randomization to No Panitumumab
n=38 Participants
Patients whose liver metastases have been completely resected will be randomized and patients randomized to Arm B will receive HAI FUDR/Dex plus systemic CPT-11/5FU/LV alone.
Randomization to No Panitumumab: All patients receive HAI FUDR (0.12 mg/kg/day X kg X pump volume) / pump flow rate and Dexamethasone flat dose of 25 mg on days 1.
All patients receive CPT-11 (150 mg/m2 IV over 30 min to an hour), Leucovorin (400 mg/m2 IV, over 30 min to an hour) and 5FU (1000 mg/m2/day continuous infusion over two days) on days 15 and 29 Randomization (to no panitumumab) Each cycle repeats every 36 days for a total of 6 cycles
|
|---|---|---|
|
Number of Participants Evaluated for Toxicity as Per the NCI Common Toxicity Criteria
|
37 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
Randomization to Panitumumab
n=37 Participants
Patients whose liver metastases have been completely resected will be randomized Arm A will receive Panitumumab in addition to HAI FUDR/Dexamethasone plus systemic CPT-11/5FU/LV
panitumumab: All patients receive HAI FUDR (0.12 mg/kg/day X kg X pump volume) / pump flow rate and Dexamethasone flat dose of 25 mg on days 1.
All patients receive CPT-11 (150 mg/m2 IV over 30 min to an hour), Leucovorin (400 mg/m2 IV, over 30 min to an hour) and 5FU (1000 mg/m2/day continuous infusion over two days) on days 15 and 29 Randomization to panitumumab 6 mg/kg day 15 and 29 Each cycle repeats every 36 days for a total of 6 cycles
|
Randomization to No Panitumumab
n=38 Participants
Patients whose liver metastases have been completely resected will be randomized and patients randomized to Arm B will receive HAI FUDR/Dex plus systemic CPT-11/5FU/LV alone.
Randomization to No Panitumumab: All patients receive HAI FUDR (0.12 mg/kg/day X kg X pump volume) / pump flow rate and Dexamethasone flat dose of 25 mg on days 1.
All patients receive CPT-11 (150 mg/m2 IV over 30 min to an hour), Leucovorin (400 mg/m2 IV, over 30 min to an hour) and 5FU (1000 mg/m2/day continuous infusion over two days) on days 15 and 29 Randomization (to no panitumumab) Each cycle repeats every 36 days for a total of 6 cycles
|
|---|---|---|
|
Participant Survival
Alive
|
22 Participants
|
11 Participants
|
|
Participant Survival
Dead
|
15 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: 2 years(such as NRAS, BRAF, PIK3CA, AKT1 and MEK1), and correlate with patient progression and survival following therapy.
Outcome measures
| Measure |
Randomization to Panitumumab
n=37 Participants
Patients whose liver metastases have been completely resected will be randomized Arm A will receive Panitumumab in addition to HAI FUDR/Dexamethasone plus systemic CPT-11/5FU/LV
panitumumab: All patients receive HAI FUDR (0.12 mg/kg/day X kg X pump volume) / pump flow rate and Dexamethasone flat dose of 25 mg on days 1.
All patients receive CPT-11 (150 mg/m2 IV over 30 min to an hour), Leucovorin (400 mg/m2 IV, over 30 min to an hour) and 5FU (1000 mg/m2/day continuous infusion over two days) on days 15 and 29 Randomization to panitumumab 6 mg/kg day 15 and 29 Each cycle repeats every 36 days for a total of 6 cycles
|
Randomization to No Panitumumab
n=38 Participants
Patients whose liver metastases have been completely resected will be randomized and patients randomized to Arm B will receive HAI FUDR/Dex plus systemic CPT-11/5FU/LV alone.
Randomization to No Panitumumab: All patients receive HAI FUDR (0.12 mg/kg/day X kg X pump volume) / pump flow rate and Dexamethasone flat dose of 25 mg on days 1.
All patients receive CPT-11 (150 mg/m2 IV over 30 min to an hour), Leucovorin (400 mg/m2 IV, over 30 min to an hour) and 5FU (1000 mg/m2/day continuous infusion over two days) on days 15 and 29 Randomization (to no panitumumab) Each cycle repeats every 36 days for a total of 6 cycles
|
|---|---|---|
|
Number of Participants With Tumor Tissue Expression of Predictive Makers
NRAS
|
1 Participants
|
1 Participants
|
|
Number of Participants With Tumor Tissue Expression of Predictive Makers
BRAF
|
0 Participants
|
2 Participants
|
|
Number of Participants With Tumor Tissue Expression of Predictive Makers
PIK3CA
|
3 Participants
|
8 Participants
|
|
Number of Participants With Tumor Tissue Expression of Predictive Makers
AKT1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Tumor Tissue Expression of Predictive Makers
MEK1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Tumor Tissue Expression of Predictive Makers
Participants without predictive tumor markers
|
33 Participants
|
27 Participants
|
Adverse Events
Randomization to Panitumumab
Serious events: 14 serious events
Other events: 27 other events
Deaths: 15 deaths
Randomization to No Panitumumab
Serious events: 6 serious events
Other events: 26 other events
Deaths: 27 deaths
Serious adverse events
| Measure |
Randomization to Panitumumab
n=37 participants at risk
Patients whose liver metastases have been completely resected will be randomized Arm A will receive Panitumumab in addition to HAI FUDR/Dexamethasone plus systemic CPT-11/5FU/LV
panitumumab: All patients receive HAI FUDR (0.12 mg/kg/day X kg X pump volume) / pump flow rate and Dexamethasone flat dose of 25 mg on days 1.
All patients receive CPT-11 (150 mg/m2 IV over 30 min to an hour), Leucovorin (400 mg/m2 IV, over 30 min to an hour) and 5FU (1000 mg/m2/day continuous infusion over two days) on days 15 and 29 Randomization to panitumumab 6 mg/kg day 15 and 29 Each cycle repeats every 36 days for a total of 6 cycles
|
Randomization to No Panitumumab
n=38 participants at risk
Patients whose liver metastases have been completely resected will be randomized and patients randomized to Arm B will receive HAI FUDR/Dex plus systemic CPT-11/5FU/LV alone.
Randomization to No Panitumumab: All patients receive HAI FUDR (0.12 mg/kg/day X kg X pump volume) / pump flow rate and Dexamethasone flat dose of 25 mg on days 1.
All patients receive CPT-11 (150 mg/m2 IV over 30 min to an hour), Leucovorin (400 mg/m2 IV, over 30 min to an hour) and 5FU (1000 mg/m2/day continuous infusion over two days) on days 15 and 29 Randomization (to no panitumumab) Each cycle repeats every 36 days for a total of 6 cycles
|
|---|---|---|
|
Investigations
Hyperbilirubinemia
|
2.7%
1/37 • 2 years
|
0.00%
0/38 • 2 years
|
|
General disorders
Chills
|
0.00%
0/37 • 2 years
|
2.6%
1/38 • 2 years
|
|
Gastrointestinal disorders
Colitis
|
2.7%
1/37 • 2 years
|
0.00%
0/38 • 2 years
|
|
Gastrointestinal disorders
Colonic obstruction
|
2.7%
1/37 • 2 years
|
0.00%
0/38 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
2.7%
1/37 • 2 years
|
0.00%
0/38 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
2.7%
1/37 • 2 years
|
0.00%
0/38 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
5.4%
2/37 • 2 years
|
2.6%
1/38 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.7%
1/37 • 2 years
|
0.00%
0/38 • 2 years
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/37 • 2 years
|
2.6%
1/38 • 2 years
|
|
General disorders
Fatigue
|
2.7%
1/37 • 2 years
|
2.6%
1/38 • 2 years
|
|
General disorders
Fever
|
8.1%
3/37 • 2 years
|
2.6%
1/38 • 2 years
|
|
Injury, poisoning and procedural complications
Fracture
|
2.7%
1/37 • 2 years
|
0.00%
0/38 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
16.2%
6/37 • 2 years
|
5.3%
2/38 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
2.7%
1/37 • 2 years
|
0.00%
0/38 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
2.7%
1/37 • 2 years
|
0.00%
0/38 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.7%
1/37 • 2 years
|
2.6%
1/38 • 2 years
|
|
Blood and lymphatic system disorders
Leukocytes
|
0.00%
0/37 • 2 years
|
2.6%
1/38 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
5.4%
2/37 • 2 years
|
2.6%
1/38 • 2 years
|
|
General disorders
Pain - Other
|
2.7%
1/37 • 2 years
|
0.00%
0/38 • 2 years
|
|
Nervous system disorders
Presyncope
|
2.7%
1/37 • 2 years
|
0.00%
0/38 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.7%
1/37 • 2 years
|
0.00%
0/38 • 2 years
|
|
Injury, poisoning and procedural complications
Rectal anastomotic leak
|
2.7%
1/37 • 2 years
|
0.00%
0/38 • 2 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
2.7%
1/37 • 2 years
|
0.00%
0/38 • 2 years
|
|
Surgical and medical procedures
Surgical and medical procedures - Other
|
2.7%
1/37 • 2 years
|
7.9%
3/38 • 2 years
|
|
Vascular disorders
Thromboembolic event
|
2.7%
1/37 • 2 years
|
0.00%
0/38 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
8.1%
3/37 • 2 years
|
2.6%
1/38 • 2 years
|
|
Investigations
Weight loss
|
0.00%
0/37 • 2 years
|
2.6%
1/38 • 2 years
|
|
Infections and infestations
Wound infection
|
5.4%
2/37 • 2 years
|
0.00%
0/38 • 2 years
|
Other adverse events
| Measure |
Randomization to Panitumumab
n=37 participants at risk
Patients whose liver metastases have been completely resected will be randomized Arm A will receive Panitumumab in addition to HAI FUDR/Dexamethasone plus systemic CPT-11/5FU/LV
panitumumab: All patients receive HAI FUDR (0.12 mg/kg/day X kg X pump volume) / pump flow rate and Dexamethasone flat dose of 25 mg on days 1.
All patients receive CPT-11 (150 mg/m2 IV over 30 min to an hour), Leucovorin (400 mg/m2 IV, over 30 min to an hour) and 5FU (1000 mg/m2/day continuous infusion over two days) on days 15 and 29 Randomization to panitumumab 6 mg/kg day 15 and 29 Each cycle repeats every 36 days for a total of 6 cycles
|
Randomization to No Panitumumab
n=38 participants at risk
Patients whose liver metastases have been completely resected will be randomized and patients randomized to Arm B will receive HAI FUDR/Dex plus systemic CPT-11/5FU/LV alone.
Randomization to No Panitumumab: All patients receive HAI FUDR (0.12 mg/kg/day X kg X pump volume) / pump flow rate and Dexamethasone flat dose of 25 mg on days 1.
All patients receive CPT-11 (150 mg/m2 IV over 30 min to an hour), Leucovorin (400 mg/m2 IV, over 30 min to an hour) and 5FU (1000 mg/m2/day continuous infusion over two days) on days 15 and 29 Randomization (to no panitumumab) Each cycle repeats every 36 days for a total of 6 cycles
|
|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
32.4%
12/37 • 2 years
|
28.9%
11/38 • 2 years
|
|
Investigations
Alkaline phosphatase increased
|
10.8%
4/37 • 2 years
|
7.9%
3/38 • 2 years
|
|
Investigations
Blood bilirubin increased
|
2.7%
1/37 • 2 years
|
2.6%
1/38 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
21.6%
8/37 • 2 years
|
10.5%
4/38 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
24.3%
9/37 • 2 years
|
0.00%
0/38 • 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
8.1%
3/37 • 2 years
|
5.3%
2/38 • 2 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.4%
2/37 • 2 years
|
7.9%
3/38 • 2 years
|
|
Investigations
Lymphopenia
|
10.8%
4/37 • 2 years
|
5.3%
2/38 • 2 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
8.1%
3/37 • 2 years
|
0.00%
0/38 • 2 years
|
|
Infections and infestations
Paronychia
|
2.7%
1/37 • 2 years
|
0.00%
0/38 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
10.8%
4/37 • 2 years
|
0.00%
0/38 • 2 years
|
Additional Information
Dr. Nancy Kemeny, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4180
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place