Trial Outcomes & Findings for RAD001 Plus Octreotide Depot in Metastatic or Unresectable Low Grade Neuroendocrine Carcinoma (NCT NCT00113360)
NCT ID: NCT00113360
Last Updated: 2025-05-01
Results Overview
PFS is measured from date of trial entry until documented progression of disease or death from any cause. PFS is measured by computed tomography (CT) scans or magnetic resonance imaging (MRI) performed at baseline and after every three cycles.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
67 participants
Primary outcome timeframe
PFS assessed every 12 weeks (at the end of every 3 cycles) or more frequently if clinically indicated
Results posted on
2025-05-01
Participant Flow
Recruitment Period: 02/2005 to 07/2006. All participants were enrolled at UT M. D. Anderson Cancer Center.
Three subjects enrolled in the screening portion of the trial did not meet eligibility requirements based on laboratory measurements.
Participant milestones
| Measure |
RAD001 Plus Octreotide Depot
RAD001 at 5 or 10 milligrams orally once a day plus Octreotide Depot 30 milligrams intramuscularly once every 28 days
|
|---|---|
|
Overall Study
STARTED
|
67
|
|
Overall Study
COMPLETED
|
60
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
RAD001 Plus Octreotide Depot
RAD001 at 5 or 10 milligrams orally once a day plus Octreotide Depot 30 milligrams intramuscularly once every 28 days
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Subject required surgery
|
1
|
|
Overall Study
Did not meet eligibility criteria
|
3
|
Baseline Characteristics
RAD001 Plus Octreotide Depot in Metastatic or Unresectable Low Grade Neuroendocrine Carcinoma
Baseline characteristics by cohort
| Measure |
RAD001 Plus Octreotide Depot
n=67 Participants
RAD001 at 5 or 10 milligrams orally once a day plus Octreotide Depot 30 milligrams intramuscularly once every 28 days
|
|---|---|
|
Age, Continuous
|
55 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
67 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: PFS assessed every 12 weeks (at the end of every 3 cycles) or more frequently if clinically indicatedPopulation: Per protocol
PFS is measured from date of trial entry until documented progression of disease or death from any cause. PFS is measured by computed tomography (CT) scans or magnetic resonance imaging (MRI) performed at baseline and after every three cycles.
Outcome measures
| Measure |
RAD001 Plus Octreotide Depot
n=60 Participants
RAD001 at 5 or 10 milligrams orally once a day plus Octreotide Depot 30 milligrams intramuscularly once every 28 days
|
|---|---|
|
Progression Free Survival (PFS)
|
60 Weeks
Interval 54.0 to 66.0
|
Adverse Events
RAD001 Plus Octreotide Depot
Serious events: 3 serious events
Other events: 64 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RAD001 Plus Octreotide Depot
n=64 participants at risk
RAD001 at 5 or 10 milligrams orally once a day plus Octreotide Depot 30 milligrams intramuscularly once every 28 days
|
|---|---|
|
Investigations
Glucose, serum-high (hyperglycemia)
|
1.6%
1/64 • Number of events 1 • 3 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
1.6%
1/64 • Number of events 1 • 3 years, 6 months
|
|
Blood and lymphatic system disorders
Hemoglobin
|
1.6%
1/64 • Number of events 1 • 3 years, 6 months
|
Other adverse events
| Measure |
RAD001 Plus Octreotide Depot
n=64 participants at risk
RAD001 at 5 or 10 milligrams orally once a day plus Octreotide Depot 30 milligrams intramuscularly once every 28 days
|
|---|---|
|
Investigations
ALT, SGPT
|
37.5%
24/64 • Number of events 37 • 3 years, 6 months
|
|
Investigations
AST,SGOT
|
62.5%
40/64 • Number of events 51 • 3 years, 6 months
|
|
Investigations
Alkaline phosphatase
|
9.4%
6/64 • Number of events 6 • 3 years, 6 months
|
|
Gastrointestinal disorders
Anorexia
|
6.2%
4/64 • Number of events 4 • 3 years, 6 months
|
|
Investigations
Bilirubin
|
6.2%
4/64 • Number of events 7 • 3 years, 6 months
|
|
Investigations
Calcium, serum-low (hypocalcemia)
|
6.2%
4/64 • Number of events 4 • 3 years, 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
32/64 • Number of events 73 • 3 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.4%
6/64 • Number of events 6 • 3 years, 6 months
|
|
Blood and lymphatic system disorders
Edema, limb
|
12.5%
8/64 • Number of events 11 • 3 years, 6 months
|
|
General disorders
Fatigue
|
62.5%
40/64 • Number of events 96 • 3 years, 6 months
|
|
General disorders
Fever (in the absence of neutropenia)
|
4.7%
3/64 • Number of events 3 • 3 years, 6 months
|
|
Gastrointestinal disorders
Flatulence
|
6.2%
4/64 • Number of events 4 • 3 years, 6 months
|
|
Investigations
Glucose, serum-high (hyperglycemia)
|
70.3%
45/64 • Number of events 76 • 3 years, 6 months
|
|
Metabolism and nutrition disorders
Glucose, serum-low (Hypoglycemia)
|
6.2%
4/64 • Number of events 5 • 3 years, 6 months
|
|
Blood and lymphatic system disorders
Hemoglobin
|
57.8%
37/64 • Number of events 43 • 3 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
46.9%
30/64 • Number of events 72 • 3 years, 6 months
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
32.8%
21/64 • Number of events 42 • 3 years, 6 months
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (Hypomagnesemia)
|
28.1%
18/64 • Number of events 21 • 3 years, 6 months
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)
|
59.4%
38/64 • Number of events 149 • 3 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
9.4%
6/64 • Number of events 6 • 3 years, 6 months
|
|
Gastrointestinal disorders
Nausea
|
43.8%
28/64 • Number of events 63 • 3 years, 6 months
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
39.1%
25/64 • Number of events 40 • 3 years, 6 months
|
|
General disorders
Pain (Abdomen NOS)
|
6.2%
4/64 • Number of events 4 • 3 years, 6 months
|
|
General disorders
Pain (Head/Headache
|
26.6%
17/64 • Number of events 28 • 3 years, 6 months
|
|
General disorders
Pain (other)
|
6.2%
4/64 • Number of events 8 • 3 years, 6 months
|
|
General disorders
Pain - Other (injection site)
|
4.7%
3/64 • Number of events 3 • 3 years, 6 months
|
|
General disorders
Pain-Other (Buttock)
|
6.2%
4/64 • Number of events 5 • 3 years, 6 months
|
|
Investigations
Phosphate, serum-low (Hypophosphatemia)
|
31.2%
20/64 • Number of events 28 • 3 years, 6 months
|
|
Blood and lymphatic system disorders
Platelets
|
37.5%
24/64 • Number of events 41 • 3 years, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
6.2%
4/64 • Number of events 4 • 3 years, 6 months
|
|
Investigations
Potassium, serum-high (hyperkalemia)
|
7.8%
5/64 • Number of events 5 • 3 years, 6 months
|
|
Metabolism and nutrition disorders
Potassium, serum-low (Hypokalemia)
|
15.6%
10/64 • Number of events 18 • 3 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
6.2%
4/64 • Number of events 4 • 3 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
34.4%
22/64 • Number of events 48 • 3 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Rash: Erythema multiforme
|
12.5%
8/64 • Number of events 12 • 3 years, 6 months
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
18.8%
12/64 • Number of events 16 • 3 years, 6 months
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
25.0%
16/64 • Number of events 17 • 3 years, 6 months
|
|
Endocrine disorders
Thyroid function, low (hypothyroidism)
|
4.7%
3/64 • Number of events 3 • 3 years, 6 months
|
|
Investigations
Triglyceride, serum-high (hypertriglyceridemia)
|
45.3%
29/64 • Number of events 43 • 3 years, 6 months
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
8/64 • Number of events 16 • 3 years, 6 months
|
|
General disorders
Weight loss
|
7.8%
5/64 • Number of events 5 • 3 years, 6 months
|
Additional Information
James Yao, M.D./Associate Professor
UT M. D. Anderson Cancer Center
Phone: 713-792-2828
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place