Trial Outcomes & Findings for Pasireotide & Everolimus in Adult Patients With Radioiodine-Refractory Differentiated & Medullary Thyroid Cancer (NCT NCT01270321)
NCT ID: NCT01270321
Last Updated: 2021-02-17
Results Overview
Number of participants with response per Response Evaluation Criteria In Solid Tumors Criteria (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."
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
Through study completion, an average of 1 year
Results posted on
2021-02-17
Participant Flow
Patients were enrolled between 11/17/2010 and 1/2/2019 at Winship Cancer Institute of Emory University
Participant milestones
| Measure |
Arm A (Everolimus Alone)
CURRENTLY CLOSED TO ACCRUAL--Everolimus alone followed by Everolimus + Pasireotide at the time of progression
Everolimus: Everolimus 10 mg daily continuously (switch to 2-drug combination at progression if no intolerable toxicity)
|
Arm B (Pasireotide Alone)
CURRENTLY CLOSED TO ACCRUAL--Pasireotide alone followed by Everolimus + Pasireotide at the time of progression
Pasireotide: Pasireotide 1200 mcg bid for 4 weeks followed by Pasireotide long acting release (LAR) 60 mg i.m. once every 4 weeks
|
Arm C (Everolimus + Pasireotide)
CURRENTLY CLOSED TO ACCRUAL
Everolimus and Pasireotide: Everolimus 10 mg daily continuously together with Pasireotide 1200 mcg bid for 4 weeks followed by Pasireotide long acting release (LAR) 60 mg i.m. once every 4 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
19
|
11
|
12
|
|
Overall Study
COMPLETED
|
9
|
1
|
3
|
|
Overall Study
NOT COMPLETED
|
10
|
10
|
9
|
Reasons for withdrawal
| Measure |
Arm A (Everolimus Alone)
CURRENTLY CLOSED TO ACCRUAL--Everolimus alone followed by Everolimus + Pasireotide at the time of progression
Everolimus: Everolimus 10 mg daily continuously (switch to 2-drug combination at progression if no intolerable toxicity)
|
Arm B (Pasireotide Alone)
CURRENTLY CLOSED TO ACCRUAL--Pasireotide alone followed by Everolimus + Pasireotide at the time of progression
Pasireotide: Pasireotide 1200 mcg bid for 4 weeks followed by Pasireotide long acting release (LAR) 60 mg i.m. once every 4 weeks
|
Arm C (Everolimus + Pasireotide)
CURRENTLY CLOSED TO ACCRUAL
Everolimus and Pasireotide: Everolimus 10 mg daily continuously together with Pasireotide 1200 mcg bid for 4 weeks followed by Pasireotide long acting release (LAR) 60 mg i.m. once every 4 weeks
|
|---|---|---|---|
|
Overall Study
Death
|
3
|
1
|
4
|
|
Overall Study
Adverse Event
|
7
|
9
|
5
|
Baseline Characteristics
Pasireotide & Everolimus in Adult Patients With Radioiodine-Refractory Differentiated & Medullary Thyroid Cancer
Baseline characteristics by cohort
| Measure |
Arm A (Everolimus Alone)
n=19 Participants
CURRENTLY CLOSED TO ACCRUAL--Everolimus alone followed by Everolimus + Pasireotide at the time of progression
Everolimus: Everolimus 10 mg daily continuously (switch to 2-drug combination at progression if no intolerable toxicity)
|
Arm B (Pasireotide Alone)
n=11 Participants
CURRENTLY CLOSED TO ACCRUAL--Pasireotide alone followed by Everolimus + Pasireotide at the time of progression
Pasireotide: Pasireotide 1200 mcg bid for 4 weeks followed by Pasireotide long acting release (LAR) 60 mg i.m. once every 4 weeks
|
Arm C (Everolimus + Pasireotide)
n=12 Participants
CURRENTLY CLOSED TO ACCRUAL
Everolimus and Pasireotide: Everolimus 10 mg daily continuously together with Pasireotide 1200 mcg bid for 4 weeks followed by Pasireotide long acting release (LAR) 60 mg i.m. once every 4 weeks
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
35 Participants
n=7 Participants
|
|
Age, Continuous
|
66.95 Years
STANDARD_DEVIATION NA • n=99 Participants
|
64.73 Years
STANDARD_DEVIATION NA • n=107 Participants
|
58.83 Years
STANDARD_DEVIATION NA • n=206 Participants
|
60.75 Years
STANDARD_DEVIATION NA • n=7 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
27 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
36 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
31 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
19 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
42 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of 1 yearNumber of participants with response per Response Evaluation Criteria In Solid Tumors Criteria (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 |
Arm A (Everolimus Alone)
n=19 Participants
CURRENTLY CLOSED TO ACCRUAL--Everolimus alone followed by Everolimus + Pasireotide at the time of progression
Everolimus: Everolimus 10 mg daily continuously (switch to 2-drug combination at progression if no intolerable toxicity)
Most frequent adverse events in \>20% of patients:
* Dry skin
* Dysgeusia
* Hypoalbuminemia
* Joint Pain
* Cough
* Diarrhea
* Hypercholesterolemia
* Hypertriglceridemia
* Hypokalemia
* Hyponatremiapnia
* Mucositis
* Rash
* Thrombocyto
|
Arm B (Pasireotide Alone)
n=11 Participants
CURRENTLY CLOSED TO ACCRUAL--Pasireotide alone followed by Everolimus + Pasireotide at the time of progression
Pasireotide: Pasireotide 1200 mcg bid for 4 weeks followed by Pasireotide long acting release (LAR) 60 mg i.m. once every 4 weeks.
Most frequent adverse events in \>20% of patients:
* Hyperbilirubinemia
* Hypertriglyceridemia
* Hypercholesterolemia
|
Arm C (Everolimus + Pasireotide)
n=12 Participants
CURRENTLY CLOSED TO ACCRUAL
Everolimus and Pasireotide: Everolimus 10 mg daily continuously together with Pasireotide 1200 mcg bid for 4 weeks followed by Pasireotide long acting release (LAR) 60 mg i.m. once every 4 weeks.
Most frequent adverse events in \>20% of patients:
* Hypercholesterolemia
* Anemia
* Headache
* Decreased Appetite
* Cough
* Mucositis
* Hyponatremia
|
|---|---|---|---|
|
Number of Participants With Response Per Responsive Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0)
|
17 Participants
|
9 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 yearTime from starting treatment until disease progression as defined using Response Evaluation CriteriaIn Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions", or death.
Outcome measures
| Measure |
Arm A (Everolimus Alone)
n=19 Participants
CURRENTLY CLOSED TO ACCRUAL--Everolimus alone followed by Everolimus + Pasireotide at the time of progression
Everolimus: Everolimus 10 mg daily continuously (switch to 2-drug combination at progression if no intolerable toxicity)
Most frequent adverse events in \>20% of patients:
* Dry skin
* Dysgeusia
* Hypoalbuminemia
* Joint Pain
* Cough
* Diarrhea
* Hypercholesterolemia
* Hypertriglceridemia
* Hypokalemia
* Hyponatremiapnia
* Mucositis
* Rash
* Thrombocyto
|
Arm B (Pasireotide Alone)
n=11 Participants
CURRENTLY CLOSED TO ACCRUAL--Pasireotide alone followed by Everolimus + Pasireotide at the time of progression
Pasireotide: Pasireotide 1200 mcg bid for 4 weeks followed by Pasireotide long acting release (LAR) 60 mg i.m. once every 4 weeks.
Most frequent adverse events in \>20% of patients:
* Hyperbilirubinemia
* Hypertriglyceridemia
* Hypercholesterolemia
|
Arm C (Everolimus + Pasireotide)
n=12 Participants
CURRENTLY CLOSED TO ACCRUAL
Everolimus and Pasireotide: Everolimus 10 mg daily continuously together with Pasireotide 1200 mcg bid for 4 weeks followed by Pasireotide long acting release (LAR) 60 mg i.m. once every 4 weeks.
Most frequent adverse events in \>20% of patients:
* Hypercholesterolemia
* Anemia
* Headache
* Decreased Appetite
* Cough
* Mucositis
* Hyponatremia
|
|---|---|---|---|
|
Number of Participants With Progression-free Survival
|
17 Participants
|
9 Participants
|
11 Participants
|
Adverse Events
Arm A (Everolimus Alone)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Arm B (Pasireotide Alone)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Arm C (Everolimus + Pasireotide)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place