Trial Outcomes & Findings for Study of (1) Everolimus, (2) Estrogen Deprivation Therapy (EDT) With Leuprolide + Letrozole and (3) Everolimus + EDT in Patients With Unresectable Fibrolamellar Hepatocellular Carcinoma (FLL-HCC) (NCT NCT01642186)
NCT ID: NCT01642186
Last Updated: 2022-12-29
Results Overview
for Part 1 of the study is progression-free survival at 6 months (PFS6). A progression event refers to the first evidence of radiographic disease progression, clinical progression as determined by study investigators, or death. Imaging performed in 6 months will be used to determine PFS6.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
6 months
Results posted on
2022-12-29
Participant Flow
Participant milestones
| Measure |
Arm A Everolimus
Everolimus will be administered at the following doses:
* Patients with a BSA ≤ 1.5 m2 will receive everolimus 5 mg PO QD.
* Patients with a BSA \> than or = to 1.5 m2 will receive everolimus 7.5 mg PO QD. If the patient is randomized to everolimus alone (1) or leuprolide and letrozole (2) and the cancer continues to grow, they may have the option to receive all three drugs together.
everolimus
|
Arm B Letrozole Plus Leuprolide
Day 1 of Cycle 1: Leuprolide 7.5 mg IM will be administered by a nurse in clinic.
Letrozole will be dispensed and will be taken at home. Patients will be instructed to take letrozole at the same time each day, consistently with food or without food, and swallowed whole with a glass of water. If the patient is randomized to everolimus alone (1) or leuprolide and letrozole (2) and the cancer continues to grow, they may have the option to receive all three drugs together.
letrozole plus leuprolide
|
Arm C Combination Everolimus, Letrozole and Leuprolide
* Patients with a BSA ≤ 1.5 m2 will receive everolimus 5 mg PO QD.
* Patients with a BSA \> than or = to 1.5 m2 will receive everolimus 7.5 mg PO QD. Leuprolide 7.5 mg IM will be given every 4 weeks (+/- 7 days). Everolimus and letrozole will be administered continuously using the same dose, schedule and administration. Everolimus, letrozole and leuprolide should be administered concurrently at all times.
combination of everolimus, letrozole and leuprolide
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
10
|
|
Overall Study
COMPLETED
|
9
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
3
|
Reasons for withdrawal
| Measure |
Arm A Everolimus
Everolimus will be administered at the following doses:
* Patients with a BSA ≤ 1.5 m2 will receive everolimus 5 mg PO QD.
* Patients with a BSA \> than or = to 1.5 m2 will receive everolimus 7.5 mg PO QD. If the patient is randomized to everolimus alone (1) or leuprolide and letrozole (2) and the cancer continues to grow, they may have the option to receive all three drugs together.
everolimus
|
Arm B Letrozole Plus Leuprolide
Day 1 of Cycle 1: Leuprolide 7.5 mg IM will be administered by a nurse in clinic.
Letrozole will be dispensed and will be taken at home. Patients will be instructed to take letrozole at the same time each day, consistently with food or without food, and swallowed whole with a glass of water. If the patient is randomized to everolimus alone (1) or leuprolide and letrozole (2) and the cancer continues to grow, they may have the option to receive all three drugs together.
letrozole plus leuprolide
|
Arm C Combination Everolimus, Letrozole and Leuprolide
* Patients with a BSA ≤ 1.5 m2 will receive everolimus 5 mg PO QD.
* Patients with a BSA \> than or = to 1.5 m2 will receive everolimus 7.5 mg PO QD. Leuprolide 7.5 mg IM will be given every 4 weeks (+/- 7 days). Everolimus and letrozole will be administered continuously using the same dose, schedule and administration. Everolimus, letrozole and leuprolide should be administered concurrently at all times.
combination of everolimus, letrozole and leuprolide
|
|---|---|---|---|
|
Overall Study
Death
|
0
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
Baseline Characteristics
Study of (1) Everolimus, (2) Estrogen Deprivation Therapy (EDT) With Leuprolide + Letrozole and (3) Everolimus + EDT in Patients With Unresectable Fibrolamellar Hepatocellular Carcinoma (FLL-HCC)
Baseline characteristics by cohort
| Measure |
Arm A Everolimus
n=9 Participants
Everolimus will be administered at the following doses:
* Patients with a BSA ≤ 1.5 m2 will receive everolimus 5 mg PO QD.
* Patients with a BSA \> than or = to 1.5 m2 will receive everolimus 7.5 mg PO QD. If the patient is randomized to everolimus alone (1) or leuprolide and letrozole (2) and the cancer continues to grow, they may have the option to receive all three drugs together.
everolimus
|
Arm B Letrozole Plus Leuprolide
n=9 Participants
Day 1 of Cycle 1: Leuprolide 7.5 mg IM will be administered by a nurse in clinic.
Letrozole will be dispensed and will be taken at home. Patients will be instructed to take letrozole at the same time each day, consistently with food or without food, and swallowed whole with a glass of water. If the patient is randomized to everolimus alone (1) or leuprolide and letrozole (2) and the cancer continues to grow, they may have the option to receive all three drugs together.
letrozole plus leuprolide
|
Arm C Combination Everolimus, Letrozole and Leuprolide
n=10 Participants
* Patients with a BSA ≤ 1.5 m2 will receive everolimus 5 mg PO QD.
* Patients with a BSA \> than or = to 1.5 m2 will receive everolimus 7.5 mg PO QD. Leuprolide 7.5 mg IM will be given every 4 weeks (+/- 7 days). Everolimus and letrozole will be administered continuously using the same dose, schedule and administration. Everolimus, letrozole and leuprolide should be administered concurrently at all times.
combination of everolimus, letrozole and leuprolide
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
26 years
n=5 Participants
|
27 years
n=7 Participants
|
29 years
n=5 Participants
|
27 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
28 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 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
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
24 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
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 monthsfor Part 1 of the study is progression-free survival at 6 months (PFS6). A progression event refers to the first evidence of radiographic disease progression, clinical progression as determined by study investigators, or death. Imaging performed in 6 months will be used to determine PFS6.
Outcome measures
| Measure |
Arm B Letrozole Plus Leuprolide
n=9 Participants
Day 1 of Cycle 1: Leuprolide 7.5 mg IM will be administered by a nurse in clinic.
Letrozole will be dispensed and will be taken at home. Patients will be instructed to take letrozole at the same time each day, consistently with food or without food, and swallowed whole with a glass of water. If the patient is randomized to everolimus alone (1) or leuprolide and letrozole (2) and the cancer continues to grow, they may have the option to receive all three drugs together.
letrozole plus leuprolide
|
Arm A Everolimus
n=9 Participants
Everolimus will be administered at the following doses:
* Patients with a BSA ≤ 1.5 m2 will receive everolimus 5 mg PO QD.
* Patients with a BSA \> than or = to 1.5 m2 will receive everolimus 7.5 mg PO QD. If the patient is randomized to everolimus alone (1) or leuprolide and letrozole (2) and the cancer continues to grow, they may have the option to receive all three drugs together.
everolimus
|
Arm C Combination Everolimus, Letrozole and Leuprolide
n=10 Participants
* Patients with a BSA ≤ 1.5 m2 will receive everolimus 5 mg PO QD.
* Patients with a BSA \> than or = to 1.5 m2 will receive everolimus 7.5 mg PO QD. Leuprolide 7.5 mg IM will be given every 4 weeks (+/- 7 days). Everolimus and letrozole will be administered continuously using the same dose, schedule and administration. Everolimus, letrozole and leuprolide should be administered concurrently at all times.
combination of everolimus, letrozole and leuprolide
|
|---|---|---|---|
|
Efficacy Endpoints for Part 1 of the Study is Progression-free Survival at 6 Months (PFS6)
Progression Free
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Efficacy Endpoints for Part 1 of the Study is Progression-free Survival at 6 Months (PFS6)
Participants With Progression
|
9 Participants
|
9 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 2 yearsKaplan-Meier PFS will be measured from the date that study therapy is initiated until the date of first evidence of radiographic disease progression, global clinical deterioration as determined by study investigators, or death.
Outcome measures
| Measure |
Arm B Letrozole Plus Leuprolide
n=9 Participants
Day 1 of Cycle 1: Leuprolide 7.5 mg IM will be administered by a nurse in clinic.
Letrozole will be dispensed and will be taken at home. Patients will be instructed to take letrozole at the same time each day, consistently with food or without food, and swallowed whole with a glass of water. If the patient is randomized to everolimus alone (1) or leuprolide and letrozole (2) and the cancer continues to grow, they may have the option to receive all three drugs together.
letrozole plus leuprolide
|
Arm A Everolimus
n=9 Participants
Everolimus will be administered at the following doses:
* Patients with a BSA ≤ 1.5 m2 will receive everolimus 5 mg PO QD.
* Patients with a BSA \> than or = to 1.5 m2 will receive everolimus 7.5 mg PO QD. If the patient is randomized to everolimus alone (1) or leuprolide and letrozole (2) and the cancer continues to grow, they may have the option to receive all three drugs together.
everolimus
|
Arm C Combination Everolimus, Letrozole and Leuprolide
n=10 Participants
* Patients with a BSA ≤ 1.5 m2 will receive everolimus 5 mg PO QD.
* Patients with a BSA \> than or = to 1.5 m2 will receive everolimus 7.5 mg PO QD. Leuprolide 7.5 mg IM will be given every 4 weeks (+/- 7 days). Everolimus and letrozole will be administered continuously using the same dose, schedule and administration. Everolimus, letrozole and leuprolide should be administered concurrently at all times.
combination of everolimus, letrozole and leuprolide
|
|---|---|---|---|
|
Median PFS
|
2.7 months
Interval 1.7 to 5.2
|
2.6 months
Interval 0.9 to 5.5
|
2.4 months
Interval 1.0 to 2.9
|
SECONDARY outcome
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 monthsKaplan-Meier OS will be measured from the date that study therapy was commenced until the date of death.
Outcome measures
| Measure |
Arm B Letrozole Plus Leuprolide
n=9 Participants
Day 1 of Cycle 1: Leuprolide 7.5 mg IM will be administered by a nurse in clinic.
Letrozole will be dispensed and will be taken at home. Patients will be instructed to take letrozole at the same time each day, consistently with food or without food, and swallowed whole with a glass of water. If the patient is randomized to everolimus alone (1) or leuprolide and letrozole (2) and the cancer continues to grow, they may have the option to receive all three drugs together.
letrozole plus leuprolide
|
Arm A Everolimus
n=9 Participants
Everolimus will be administered at the following doses:
* Patients with a BSA ≤ 1.5 m2 will receive everolimus 5 mg PO QD.
* Patients with a BSA \> than or = to 1.5 m2 will receive everolimus 7.5 mg PO QD. If the patient is randomized to everolimus alone (1) or leuprolide and letrozole (2) and the cancer continues to grow, they may have the option to receive all three drugs together.
everolimus
|
Arm C Combination Everolimus, Letrozole and Leuprolide
n=10 Participants
* Patients with a BSA ≤ 1.5 m2 will receive everolimus 5 mg PO QD.
* Patients with a BSA \> than or = to 1.5 m2 will receive everolimus 7.5 mg PO QD. Leuprolide 7.5 mg IM will be given every 4 weeks (+/- 7 days). Everolimus and letrozole will be administered continuously using the same dose, schedule and administration. Everolimus, letrozole and leuprolide should be administered concurrently at all times.
combination of everolimus, letrozole and leuprolide
|
|---|---|---|---|
|
Median Overall Survival (OS)
|
14.0 months
Interval 3.2 to 22.4
|
12.5 months
Interval 2.7 to 41.9
|
10.6 months
Interval 2.3 to 20.9
|
SECONDARY outcome
Timeframe: 2 yearsObjective responses will be reported using RECIST guidelines (version 1.1). Objective response will be estimated using binomial proportions and exact 95% CIs will be provided. Stable Disease is defined as neither sufficient shrinkage (compared to baseline) to qualify for Partial Reponse nor sufficient increase (taking as reference the smallest sum diameters while on study) to qualify for Progressive Disease.
Outcome measures
| Measure |
Arm B Letrozole Plus Leuprolide
n=9 Participants
Day 1 of Cycle 1: Leuprolide 7.5 mg IM will be administered by a nurse in clinic.
Letrozole will be dispensed and will be taken at home. Patients will be instructed to take letrozole at the same time each day, consistently with food or without food, and swallowed whole with a glass of water. If the patient is randomized to everolimus alone (1) or leuprolide and letrozole (2) and the cancer continues to grow, they may have the option to receive all three drugs together.
letrozole plus leuprolide
|
Arm A Everolimus
n=9 Participants
Everolimus will be administered at the following doses:
* Patients with a BSA ≤ 1.5 m2 will receive everolimus 5 mg PO QD.
* Patients with a BSA \> than or = to 1.5 m2 will receive everolimus 7.5 mg PO QD. If the patient is randomized to everolimus alone (1) or leuprolide and letrozole (2) and the cancer continues to grow, they may have the option to receive all three drugs together.
everolimus
|
Arm C Combination Everolimus, Letrozole and Leuprolide
n=10 Participants
* Patients with a BSA ≤ 1.5 m2 will receive everolimus 5 mg PO QD.
* Patients with a BSA \> than or = to 1.5 m2 will receive everolimus 7.5 mg PO QD. Leuprolide 7.5 mg IM will be given every 4 weeks (+/- 7 days). Everolimus and letrozole will be administered continuously using the same dose, schedule and administration. Everolimus, letrozole and leuprolide should be administered concurrently at all times.
combination of everolimus, letrozole and leuprolide
|
|---|---|---|---|
|
Percentage of Participants With Stable Disease
|
37 Percentage of pts with stable disease
|
55 Percentage of pts with stable disease
|
11 Percentage of pts with stable disease
|
SECONDARY outcome
Timeframe: 2 yearsAdverse events/toxicity will be monitored and recorded using the CTCAE version 4.0 and summarized descriptively.
Outcome measures
| Measure |
Arm B Letrozole Plus Leuprolide
n=9 Participants
Day 1 of Cycle 1: Leuprolide 7.5 mg IM will be administered by a nurse in clinic.
Letrozole will be dispensed and will be taken at home. Patients will be instructed to take letrozole at the same time each day, consistently with food or without food, and swallowed whole with a glass of water. If the patient is randomized to everolimus alone (1) or leuprolide and letrozole (2) and the cancer continues to grow, they may have the option to receive all three drugs together.
letrozole plus leuprolide
|
Arm A Everolimus
n=9 Participants
Everolimus will be administered at the following doses:
* Patients with a BSA ≤ 1.5 m2 will receive everolimus 5 mg PO QD.
* Patients with a BSA \> than or = to 1.5 m2 will receive everolimus 7.5 mg PO QD. If the patient is randomized to everolimus alone (1) or leuprolide and letrozole (2) and the cancer continues to grow, they may have the option to receive all three drugs together.
everolimus
|
Arm C Combination Everolimus, Letrozole and Leuprolide
n=10 Participants
* Patients with a BSA ≤ 1.5 m2 will receive everolimus 5 mg PO QD.
* Patients with a BSA \> than or = to 1.5 m2 will receive everolimus 7.5 mg PO QD. Leuprolide 7.5 mg IM will be given every 4 weeks (+/- 7 days). Everolimus and letrozole will be administered continuously using the same dose, schedule and administration. Everolimus, letrozole and leuprolide should be administered concurrently at all times.
combination of everolimus, letrozole and leuprolide
|
|---|---|---|---|
|
Number of Participants With One or More Adverse Events/Toxicity
|
9 Participants
|
9 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 2 yearsAssociations between baseline tissue biomarkers and PFS6 will be assessed using Fisher's exact test for categorical biomarkers, trend tests for ordinal biomarkers and Wilcoxon rank-sum test for continuous biomarkers. For patients undergoing surgery, changes in tissue biomarkers from baseline to surgery will be summarized descriptively in an exploratory fashion.
Outcome measures
| Measure |
Arm B Letrozole Plus Leuprolide
n=9 Participants
Day 1 of Cycle 1: Leuprolide 7.5 mg IM will be administered by a nurse in clinic.
Letrozole will be dispensed and will be taken at home. Patients will be instructed to take letrozole at the same time each day, consistently with food or without food, and swallowed whole with a glass of water. If the patient is randomized to everolimus alone (1) or leuprolide and letrozole (2) and the cancer continues to grow, they may have the option to receive all three drugs together.
letrozole plus leuprolide
|
Arm A Everolimus
n=9 Participants
Everolimus will be administered at the following doses:
* Patients with a BSA ≤ 1.5 m2 will receive everolimus 5 mg PO QD.
* Patients with a BSA \> than or = to 1.5 m2 will receive everolimus 7.5 mg PO QD. If the patient is randomized to everolimus alone (1) or leuprolide and letrozole (2) and the cancer continues to grow, they may have the option to receive all three drugs together.
everolimus
|
Arm C Combination Everolimus, Letrozole and Leuprolide
n=10 Participants
* Patients with a BSA ≤ 1.5 m2 will receive everolimus 5 mg PO QD.
* Patients with a BSA \> than or = to 1.5 m2 will receive everolimus 7.5 mg PO QD. Leuprolide 7.5 mg IM will be given every 4 weeks (+/- 7 days). Everolimus and letrozole will be administered continuously using the same dose, schedule and administration. Everolimus, letrozole and leuprolide should be administered concurrently at all times.
combination of everolimus, letrozole and leuprolide
|
|---|---|---|---|
|
Number of Participants With Tissue Biomarkers Collected
|
9 Participants
|
9 Participants
|
10 Participants
|
Adverse Events
Arm A Everolimus
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Arm B Letrozole Plus Leuprolide
Serious events: 0 serious events
Other events: 9 other events
Deaths: 2 deaths
Arm C Combination Everolimus, Letrozole and Leuprolide
Serious events: 0 serious events
Other events: 9 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm A Everolimus
n=9 participants at risk
Everolimus will be administered at the following doses:
* Patients with a BSA ≤ 1.5 m2 will receive everolimus 5 mg PO QD.
* Patients with a BSA \> than or = to 1.5 m2 will receive everolimus 7.5 mg PO QD. If the patient is randomized to everolimus alone (1) or leuprolide and letrozole (2) and the cancer continues to grow, they may have the option to receive all three drugs together.
everolimus
|
Arm B Letrozole Plus Leuprolide
n=9 participants at risk
Day 1 of Cycle 1: Leuprolide 7.5 mg IM will be administered by a nurse in clinic.
Letrozole will be dispensed and will be taken at home. Patients will be instructed to take letrozole at the same time each day, consistently with food or without food, and swallowed whole with a glass of water. If the patient is randomized to everolimus alone (1) or leuprolide and letrozole (2) and the cancer continues to grow, they may have the option to receive all three drugs together.
letrozole plus leuprolide
|
Arm C Combination Everolimus, Letrozole and Leuprolide
n=10 participants at risk
* Patients with a BSA ≤ 1.5 m2 will receive everolimus 5 mg PO QD.
* Patients with a BSA \> than or = to 1.5 m2 will receive everolimus 7.5 mg PO QD. Leuprolide 7.5 mg IM will be given every 4 weeks (+/- 7 days). Everolimus and letrozole will be administered continuously using the same dose, schedule and administration. Everolimus, letrozole and leuprolide should be administered concurrently at all times.
combination of everolimus, letrozole and leuprolide
|
|---|---|---|---|
|
Investigations
ALT increased
|
77.8%
7/9 • Up to 100 months
|
77.8%
7/9 • Up to 100 months
|
80.0%
8/10 • Up to 100 months
|
|
Investigations
Alkaline phosphatase increased
|
77.8%
7/9 • Up to 100 months
|
88.9%
8/9 • Up to 100 months
|
90.0%
9/10 • Up to 100 months
|
|
Blood and lymphatic system disorders
Anemia
|
44.4%
4/9 • Up to 100 months
|
88.9%
8/9 • Up to 100 months
|
80.0%
8/10 • Up to 100 months
|
|
Investigations
AST increased
|
88.9%
8/9 • Up to 100 months
|
88.9%
8/9 • Up to 100 months
|
80.0%
8/10 • Up to 100 months
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/9 • Up to 100 months
|
33.3%
3/9 • Up to 100 months
|
30.0%
3/10 • Up to 100 months
|
|
Investigations
Cholesterol high
|
55.6%
5/9 • Up to 100 months
|
33.3%
3/9 • Up to 100 months
|
30.0%
3/10 • Up to 100 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/9 • Up to 100 months
|
11.1%
1/9 • Up to 100 months
|
20.0%
2/10 • Up to 100 months
|
|
General disorders
Fatigue
|
88.9%
8/9 • Up to 100 months
|
88.9%
8/9 • Up to 100 months
|
60.0%
6/10 • Up to 100 months
|
|
Gastrointestinal disorders
Mucositis oral
|
33.3%
3/9 • Up to 100 months
|
11.1%
1/9 • Up to 100 months
|
30.0%
3/10 • Up to 100 months
|
|
Gastrointestinal disorders
Nausea
|
33.3%
3/9 • Up to 100 months
|
44.4%
4/9 • Up to 100 months
|
50.0%
5/10 • Up to 100 months
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/9 • Up to 100 months
|
11.1%
1/9 • Up to 100 months
|
30.0%
3/10 • Up to 100 months
|
|
Investigations
Platelet count decreased
|
33.3%
3/9 • Up to 100 months
|
22.2%
2/9 • Up to 100 months
|
60.0%
6/10 • Up to 100 months
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
3/9 • Up to 100 months
|
55.6%
5/9 • Up to 100 months
|
40.0%
4/10 • Up to 100 months
|
|
Investigations
White blood cell decreased
|
33.3%
3/9 • Up to 100 months
|
33.3%
3/9 • Up to 100 months
|
70.0%
7/10 • Up to 100 months
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
66.7%
6/9 • Up to 100 months
|
33.3%
3/9 • Up to 100 months
|
40.0%
4/10 • Up to 100 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
44.4%
4/9 • Up to 100 months
|
55.6%
5/9 • Up to 100 months
|
80.0%
8/10 • Up to 100 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
11.1%
1/9 • Up to 100 months
|
11.1%
1/9 • Up to 100 months
|
0.00%
0/10 • Up to 100 months
|
|
General disorders
Death - NOS
|
0.00%
0/9 • Up to 100 months
|
22.2%
2/9 • Up to 100 months
|
20.0%
2/10 • Up to 100 months
|
Additional Information
Dr. Ghassan Abou-Alfa, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-824-6566
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place