Trial Outcomes & Findings for Study of Lanreotide in Patients With Metastatic Gastrointestinal Neuroendocrine Tumors Who Are Undergoing Liver-directed Radioembolization With Yttrium-90 Microspheres (NCT NCT02859064)
NCT ID: NCT02859064
Last Updated: 2023-12-05
Results Overview
Treatment-emergent Adverse Events were assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
From the day of the first dose to 30 days after the last dose of study medication, up to 52 months
Results posted on
2023-12-05
Participant Flow
Participant milestones
| Measure |
Lanreotide/Y-90 Microspheres
Lanreotide: 120 mg by subcutaneous injection (SQ) on Day 1 of every cycle (every 28 days) in combination with SIR-Spheres therapy.
Y-90 (Yttrium-90) microspheres \[SIR-Spheres therapy\]: dose and treatment day to be determined by treating radiation oncologist.
Lanreotide: Administered every 28 days irrespective of when SIR-Spheres is administered. No waiting or adjusting of schedule is required. Lanreotide treatment may continue monthly until disease progression or unacceptable toxicity occurs.
Y-90 microspheres: To be administered by injection through a trans-femoral catheter into the hepatic artery.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Lanreotide/Y-90 Microspheres
Lanreotide: 120 mg by subcutaneous injection (SQ) on Day 1 of every cycle (every 28 days) in combination with SIR-Spheres therapy.
Y-90 (Yttrium-90) microspheres \[SIR-Spheres therapy\]: dose and treatment day to be determined by treating radiation oncologist.
Lanreotide: Administered every 28 days irrespective of when SIR-Spheres is administered. No waiting or adjusting of schedule is required. Lanreotide treatment may continue monthly until disease progression or unacceptable toxicity occurs.
Y-90 microspheres: To be administered by injection through a trans-femoral catheter into the hepatic artery.
|
|---|---|
|
Overall Study
Progressive Disease
|
3
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Study of Lanreotide in Patients With Metastatic Gastrointestinal Neuroendocrine Tumors Who Are Undergoing Liver-directed Radioembolization With Yttrium-90 Microspheres
Baseline characteristics by cohort
| Measure |
Lanreotide/Y-90 Microspheres
n=6 Participants
Lanreotide: 120 mg by subcutaneous injection (SQ) on Day 1 of every cycle (every 28 days) in combination with SIR-Spheres therapy.
Y-90 (Yttrium-90) microspheres \[SIR-Spheres therapy\]: dose and treatment day to be determined by treating radiation oncologist.
Lanreotide: Administered every 28 days irrespective of when SIR-Spheres is administered. No waiting or adjusting of schedule is required. Lanreotide treatment may continue monthly until disease progression or unacceptable toxicity occurs.
Y-90 microspheres: To be administered by injection through a trans-femoral catheter into the hepatic artery.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 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
|
0 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
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the day of the first dose to 30 days after the last dose of study medication, up to 52 monthsPopulation: All enrolled patients who received at least one dose of both study medications, at least one dose of lanreotide and at least one dose of Y-90 microspheres.
Treatment-emergent Adverse Events were assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Outcome measures
| Measure |
Lanreotide/Y-90 Microspheres
n=6 Participants
Lanreotide: 120 mg by subcutaneous injection (SQ) on Day 1 of every cycle (every 28 days) in combination with SIR-Spheres therapy.
Y-90 (Yttrium-90) microspheres \[SIR-Spheres therapy\]: dose and treatment day to be determined by treating radiation oncologist.
Lanreotide: Administered every 28 days irrespective of when SIR-Spheres is administered. No waiting or adjusting of schedule is required. Lanreotide treatment may continue monthly until disease progression or unacceptable toxicity occurs.
Y-90 microspheres: To be administered by injection through a trans-femoral catheter into the hepatic artery.
|
|---|---|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
|
6 Participants
|
SECONDARY outcome
Timeframe: At 12 weeks post-treatment with SIR-Spheres then every 8 weeks, up to 52 monthsPopulation: All enrolled patients who received at least one full dose of lanreotide and y-90 microspheres
Percentage of patients with confirmed complete or partial response (CR or PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1),: Complete Response (CR): Disappearance of all target and non-target lesions; Partial Response (PR): \>=30% decrease in the sum of the diameters of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Lanreotide/Y-90 Microspheres
n=6 Participants
Lanreotide: 120 mg by subcutaneous injection (SQ) on Day 1 of every cycle (every 28 days) in combination with SIR-Spheres therapy.
Y-90 (Yttrium-90) microspheres \[SIR-Spheres therapy\]: dose and treatment day to be determined by treating radiation oncologist.
Lanreotide: Administered every 28 days irrespective of when SIR-Spheres is administered. No waiting or adjusting of schedule is required. Lanreotide treatment may continue monthly until disease progression or unacceptable toxicity occurs.
Y-90 microspheres: To be administered by injection through a trans-femoral catheter into the hepatic artery.
|
|---|---|
|
Overall Response Rate
|
16.7 percentage of participants
|
SECONDARY outcome
Timeframe: At 12 weeks post-treatment with SIR-Spheres then every 8 weeks, up to 52 months.Population: All enrolled patients who received at least one full dose of lanreotide and y-90 microspheres.
Percentage of patients with CR, PR or stable disease (SD) according to RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1),: Complete Response (CR): Disappearance of all target and non-target lesions; Partial Response (PR): \>=30% decrease in the sum of the diameters of target lesions; Stable Disease: Meeting neither criteria for PR or Progression (PD= greater than 20% increase in the sum of diameters of target lesions, or an unequivocal increase in a non-target lesion, or the appearance of new lesions). Disease Control Rate (DCR) = CR + PR + SD.
Outcome measures
| Measure |
Lanreotide/Y-90 Microspheres
n=6 Participants
Lanreotide: 120 mg by subcutaneous injection (SQ) on Day 1 of every cycle (every 28 days) in combination with SIR-Spheres therapy.
Y-90 (Yttrium-90) microspheres \[SIR-Spheres therapy\]: dose and treatment day to be determined by treating radiation oncologist.
Lanreotide: Administered every 28 days irrespective of when SIR-Spheres is administered. No waiting or adjusting of schedule is required. Lanreotide treatment may continue monthly until disease progression or unacceptable toxicity occurs.
Y-90 microspheres: To be administered by injection through a trans-femoral catheter into the hepatic artery.
|
|---|---|
|
Disease Control Rate
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: At 12 weeks post-treatment with SIR-Spheres then every 8 weeks, up to 52 monthsPopulation: All enrolled patients who received at least one full dose of lanreotide and y-90 microspheres.
The time from Day 1 of study drug administration to disease progression as defined by RECIST v1.1, or death on study. Per RECIST V1.1 criteria, progression is defined as a greater than 20% increase in the sum of diameters of target lesions, or an unequivocal increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Lanreotide/Y-90 Microspheres
n=6 Participants
Lanreotide: 120 mg by subcutaneous injection (SQ) on Day 1 of every cycle (every 28 days) in combination with SIR-Spheres therapy.
Y-90 (Yttrium-90) microspheres \[SIR-Spheres therapy\]: dose and treatment day to be determined by treating radiation oncologist.
Lanreotide: Administered every 28 days irrespective of when SIR-Spheres is administered. No waiting or adjusting of schedule is required. Lanreotide treatment may continue monthly until disease progression or unacceptable toxicity occurs.
Y-90 microspheres: To be administered by injection through a trans-femoral catheter into the hepatic artery.
|
|---|---|
|
Progression Free Survival
|
11 months
Interval 3.6 to 51.4
|
SECONDARY outcome
Timeframe: At 12 weeks post-treatment with SIR-Spheres then every 8 weeks, up to 52 monthsPopulation: All enrolled patients who received at least one full dose of lanreotide and y-90 microspheres.
The time from Day 1 of study drug administration until death from any cause.
Outcome measures
| Measure |
Lanreotide/Y-90 Microspheres
n=6 Participants
Lanreotide: 120 mg by subcutaneous injection (SQ) on Day 1 of every cycle (every 28 days) in combination with SIR-Spheres therapy.
Y-90 (Yttrium-90) microspheres \[SIR-Spheres therapy\]: dose and treatment day to be determined by treating radiation oncologist.
Lanreotide: Administered every 28 days irrespective of when SIR-Spheres is administered. No waiting or adjusting of schedule is required. Lanreotide treatment may continue monthly until disease progression or unacceptable toxicity occurs.
Y-90 microspheres: To be administered by injection through a trans-femoral catheter into the hepatic artery.
|
|---|---|
|
Overall Survival
|
11.5 months
Interval 3.7 to 51.4
|
Adverse Events
Lanreotide/Y-90 Microspheres
Serious events: 2 serious events
Other events: 6 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Lanreotide/Y-90 Microspheres
n=6 participants at risk
Lanreotide: 120 mg by subcutaneous injection (SQ) on Day 1 of every cycle (every 28 days) in combination with SIR-Spheres therapy.
Y-90 (Yttrium-90) microspheres \[SIR-Spheres therapy\]: dose and treatment day to be determined by treating radiation oncologist.
Lanreotide: Administered every 28 days irrespective of when SIR-Spheres is administered. No waiting or adjusting of schedule is required. Lanreotide treatment may continue monthly until disease progression or unacceptable toxicity occurs.
Y-90 microspheres: To be administered by injection through a trans-femoral catheter into the hepatic artery.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Asthenia
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Infections and infestations
Sepsis
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Cardiac disorders
Cardiac Arrest
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
Other adverse events
| Measure |
Lanreotide/Y-90 Microspheres
n=6 participants at risk
Lanreotide: 120 mg by subcutaneous injection (SQ) on Day 1 of every cycle (every 28 days) in combination with SIR-Spheres therapy.
Y-90 (Yttrium-90) microspheres \[SIR-Spheres therapy\]: dose and treatment day to be determined by treating radiation oncologist.
Lanreotide: Administered every 28 days irrespective of when SIR-Spheres is administered. No waiting or adjusting of schedule is required. Lanreotide treatment may continue monthly until disease progression or unacceptable toxicity occurs.
Y-90 microspheres: To be administered by injection through a trans-femoral catheter into the hepatic artery.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Cardiac disorders
Acute myocardial infarction
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Cardiac disorders
Cardiac arrest
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Ear and labyrinth disorders
Vertigo
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Eye disorders
Macular hole
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Eye disorders
Retinal tear
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Gastrointestinal disorders
Abdominal distension
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
2/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Gastrointestinal disorders
Ascites
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Gastrointestinal disorders
Diverticulum
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Gastrointestinal disorders
Flatulence
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
4/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
General disorders
Asthenia
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
General disorders
Chills
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
General disorders
Fatigue
|
66.7%
4/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
General disorders
Oedema peripheral
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
General disorders
Pain
|
33.3%
2/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
General disorders
Pyrexia
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Infections and infestations
Clostridium difficile infection
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Infections and infestations
Gingivitis
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Infections and infestations
Sepsis
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Investigations
Blood alkaline phosphatase increased
|
33.3%
2/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Investigations
Blood lactic acid increased
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Nervous system disorders
Hypoaesthesia
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Nervous system disorders
Paraesthesia
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Psychiatric disorders
Depression
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Psychiatric disorders
Mental status changes
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Psychiatric disorders
Suicidal ideation
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
2/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Skin and subcutaneous tissue disorders
Erythema annulare
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Vascular disorders
Flushing
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Vascular disorders
Hot flush
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
|
Vascular disorders
Peripheral coldness
|
16.7%
1/6 • From the date of first dose to 30 days after last dose of study treatment, up to 52 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
|
Additional Information
Sarah Cannon Development Innovations, LLC
Sarah Cannon Development Innovations, LLC
Phone: 844-710-6157
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60