Pasireotide in Prevention of GI Toxicity

Sponsor
Anthony Sung, MD (Other)
Overall Status
Completed
CT.gov ID
NCT02215070
Collaborator
Massachusetts General Hospital (Other)
37
Enrollment
2
Locations
1
Arm
56.8
Actual Duration (Months)
18.5
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate if the drug, Pasireotide, is safe and effective in reducing the gastrointestinal side effects of the drugs received to prepare for allogeneic stem cell transplant. The study will also evaluate if Pasireotide is effective in reducing acute and chronic Graft-versus-Host-Disease (GvHD) after transplant.

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

Detailed Description

The study design will be a non-randomized phase II. Forty patients receiving an ablative preparatory regimen will receive pasireotide subcutaneous (0.9 mg, b.i.d.) one day prior to initiation of the preparatory regimen and continuing for eight days following the completion of the preparatory regimen not to exceed 14 days total dosing. We select matched controls from existing patients who did not take the drug to minimize the time it takes to complete the trial.

Myeloablative preparatory regimens are defined as those including either TBI ≥ 1200 cGy or busulfan ≥ 12.8 mg/kg. The most common regimens combine TBI with cyclophosphamide (TBI/Cy) or busulfan with cyclophosphamide (Bu/Cy) (Appendix E). However, any regimen meeting the above definition of myeloablative preparatory regimen may be used.

The study will collect data at screening, at baseline prior to initiation of the drug (day of study drug start), transplant day 0, day +7, day +14 and weekly thereafter until day +100, and on days +180, +270, and +365. The total days on pasireotide therapy will be recorded as well as any SAE that is outside the expected for stem cell transplantation. We will also follow the incidence and severity of acute and chronic GVHD.

At Duke only, a video capsule endoscopy will be performed in a subset of ten study patients between transplant days +4 through +6. This substudy is descriptive in nature and only used to collect a source of preliminary data that may suggest further study.

Patients must agree to participate in this portion of the study and will be asked to sign a clinical consent for performance use of the video capsule endoscopy. Patients will be given detailed instructions to prepare for the procedure. An investigator who is blinded to the group allocation of the patients/volunteers separately will review the images obtained from each of the capsule examinations. Images will be examined for evidence of the four following types of abnormalities: reddened/edema/villous blunting, erosion, ulcer and stenosis. Each of these categories will be scored from 0-3 and summed to obtain an overall index that will range from 0 (normal study) to 12 (severely abnormal in all categories).

Citrulline assay Measurement of citrulline concentration has been used as a marker for cytotoxic treatment-induced intestinal damage and it is highly reproducible. The citrulline concentration appears to be a quantitative parameter that is independent of the underlying cause for epithelial cell loss and functions well in the post-SCT setting. Six mls of blood will be collected in heparinized tubes on days 0, 7, and 14. Tubes will be centrifuged according to manufacturer's instructions and the plasma will be collected and stored at -80C until shipment to the laboratory performing the assay.

Calprotectin assay Calprotectin has been described as another biomarker of GI injury. During radiation-induced inflammation, leucocytes infiltrate the mucosa and increase the level of fecal calprotectin. At least 50 mg of stool specimen will be collected from patients on days 0, 7, and 14. Samples will be stored at -80C until shipment to the laboratory performing the assay. Calprotectin will be measured with an ELISA kit (CALPRO, Oslo, Norway) in accordance with the manufacturer's instructions.

Study Design

Study Type:
Interventional
Actual Enrollment :
37 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prevention of Gastrointestinal Toxicity From Total Body Irradiation or High Dose Chemotherapy With Pasireotide
Actual Study Start Date :
Jan 21, 2015
Actual Primary Completion Date :
Feb 28, 2019
Actual Study Completion Date :
Oct 15, 2019

Arms and Interventions

ArmIntervention/Treatment
Experimental: Pasireotide + Preparatory Regimen

Eligible subjects will receive pasireotide daily for 5 days before stem cell transplant, the day of the stem cell transplant, and daily for 8 days following the stem cell transplant. Preparatory regimen will be given 4 days before stem cell transplant.

Drug: Pasireotide
Eligible subjects will receive pasireotide daily for 5 days before stem cell transplant, the day of the stem cell transplant, and daily for 8 days following the stem cell transplant. Preparatory regimen will be given 4 days before stem cell transplant.

Outcome Measures

Primary Outcome Measures

  1. Percentage of GI Toxicity From the Preparatory Regimen and the GVHD Prophylaxis in Stem Cell Transplantation (SCT) Patients Who Are Treated With Pasireotide [30 Days]

    Number of participants who experience grades III-IV GI toxicity

Secondary Outcome Measures

  1. Percentage of Acute GVHD [100 days]

    Number of participants who experience acute GVHD

  2. Maximum Severity of Acute GVHD Compared to Historical Controls [100 days]

    Assess maximum severity of acute GVHD scored as stage 1 (least severe) through stage 4 (most severe) using BMT CTN, 2013 standards

  3. Incidence of Chronic GVHD Compared to Historical Controls [1 year]

    Measure the number of participants who experience chronic GVHD

  4. Maximum Severity of Chronic GVHD Compared to Historical Controls [1 year]

    Assess maximum severity of chronic GVHD scored as none, mild, moderate or severe using 2014 NIH Consensus Criteria

  5. Overall Survival Compared to Historical Controls [1 year]

    Rate of overall survival of participants at one year post transplant

  6. Disease Free Survival Compared to Historical Controls [1 year]

    Rate of disease free survival of participants at one year post transplant

Other Outcome Measures

  1. Citrulline and Fecal Calprotectin Levels Will be Measured [100 days]

    Exploratory outcome-These levels will be evaluated as biomarkers of GI tract health and function in SCT patients and the correlation between these biomarkers and GI toxicity.

  2. Evaluate GI Toxicity Assessment by Video Capsule Endoscopy. [14 days]

    Exploratory outcome-Video capsule endoscopy will be performed in a subset of ten study participants on the last day study drug is administered. Images will be examined for evidence of the four following types of abnormalities: reddened/edema/villous blunting, erosion, ulcer and stenosis.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 18 years of age or older at the time of study enrollment.

  • Histologically confirmed diagnosis for which an allogeneic transplant is utilized.

  • Plan to receive an allogeneic transplant from a 4-6/6 single or dual umbilical cord blood graft, or a 7-8/8 HLA-matched sibling or unrelated donor (High resolution HLA-A, B, C, DRB1).

  • Meet standard criteria as defined by the institution for a myeloablative allogeneic stem cell transplantation, with myeloablative defined as using conditioning regimens containing:

  • TBI ≥ 1200 cGy, or

  • Busulfan ≥ 12.8mg/kg

  • Patient must have given written informed consent according to FDA guidelines.

  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.

Exclusion Criteria:
  • Female patients who are pregnant or lactating, or are of childbearing potential (FCBP, defined as all women physiologically capable of becoming pregnant) and not practicing an effective method of contraception/birth control

  • FCBP must have a current negative serum pregnancy test prior to transplant per institutional practice.

  • Use of an investigational drug within 1 month prior to dosing. Concurrent enrollment on other clinical research studies that contain an interventional therapy is not permitted while subjects are receiving pasireotide or within 5 half-lives of finishing pasireotide. However, subjects may concurrently enroll in non-interventional studies (e.g. biobanking, mobile health tracking).

  • Active CNS disease (related to primary malignancy) at the time of enrollment.

  • Patients with existing grade 2 toxicities, except as approved by the investigator.

  • Any of the following diseases or conditions:

Cardiac:
  • History of unexplained syncope or family history of idiopathic sudden death.

  • Sustained or clinically significant cardiac arrhythmias.

  • Risk factors for Torsades de Pointes such as:

  • Uncontrolled hypokalemia

  • Uncontrolled hypomagnesemia or hypermagnesemia

  • Cardiac failure (New York Heart Association Class II or higher)

  • Clinically significant/symptomatic bradycardia (HR < 50), or high-grade AV block.

  • Known diagnosis of QT prolongation (QTc ≥ 470) or family history of long QT syndrome

  • Concomitant disease(s) that could prolong QT such as autonomic neuropathy (caused by diabetes, or Parkinson's disease), HIV, cirrhosis, uncontrolled hypothyroidism or cardiac failure.

  • Concomitant medications known to prolong the QT interval during the same time as pasireotide is to be administered (unless approved by PI and QTc < 470; standard transplant medications that are known to prolong the QT (e.g. azoles, ondansetron, etc.) are permitted but caution is advised and patients should be closely monitored).

Endocrine:
  • Uncontrolled diabetes at the time of cytoreduction. All patients with diabetes must be optimized on their diabetes regimen prior to initiating pasireotide.

• If a patient is diabetic: uncontrolled diabetes as defined by HbA1c > 8 per cent despite adequate therapy

  • Patients who are not biochemically euthyroid. Patients with known history of hypothyroidism are eligible if they are on adequate and stable replacement thyroid hormone therapy for at least 3 months.

  • Known diagnosis of hypocortisolism

  • Known diagnosis of pituitary hormone deficiency.

  • Known hypersensitivity to somatostatin analogs or any component of the pasireotide LAR or s.c. formulations.

Infectious:
  • Uncontrolled (not being treated) infections at the time of cytoreduction.

  • A positive HIV test result (ELISA and Western blot) or history of known HIV. An HIV test will not be required; however, previous medical history will be reviewed.

Gastrointestinal:
  • Moderately impaired hepatic function (Child-Pugh B) or severe hepatic impairment (Child-Pugh C)

  • Known gallbladder or bile duct disease, symptomatic cholelithiasis, acute or chronic pancreatitis.

  • Known malabsorption syndrome, short bowel or chologenic diarrhea not controlled by specific therapeutic means.

Hematologic:
  • Abnormal coagulation (PT or aPTT > 30% above normal limits).

  • Continuous anticoagulation therapy. Patients who were on anticoagulant therapy must complete a washout period of at least 10 days and have confirmed normal coagulation parameters before study inclusion.

Miscellaneous:
  • Major surgery/surgical therapy for any cause within 1 month prior to pasireotide administration. Patients should have recovered and have a good clinical condition before entering the study.

  • Any co-morbid condition which, in the view of the Principal Investigator, renders the patient at high risk from treatment complications.

Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will not be able to complete the entire study.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Massachusetts General HospitalBostonMassachusettsUnited States02114
2Duke University Medical CenterDurhamNorth CarolinaUnited States27705

Sponsors and Collaborators

  • Anthony Sung, MD
  • Massachusetts General Hospital

Investigators

  • Principal Investigator: Anthony Sung, MD, Duke University

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Anthony Sung, MD, Professor of Medicine, Duke University
ClinicalTrials.gov Identifier:
NCT02215070
Other Study ID Numbers:
  • Pro00051736
First Posted:
Aug 13, 2014
Last Update Posted:
Nov 17, 2021
Last Verified:
Oct 1, 2021

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail5 enrolled participants screen failed, 5 withdrew, and 1 was withdrawn by physician decision.
Arm/Group TitlePasireotide + Preparatory RegimenHistorical Controls
Arm/Group DescriptionEligible subjects will receive pasireotide daily for 5 days before stem cell transplant, the day of the stem cell transplant, and daily for 8 days following the stem cell transplant. Preparatory regimen will be given 4 days before stem cell transplant.Contemporaneous controls were matched using the following parameters: Transplant diagnosis (acute leukemias, lymphomas, myelodysplastic syndrome [MDS]/myeloproliferative neoplasm [MPN]/other), donor (related, unrelated), graft (bone marrow, peripheral blood progenitor cell [PBPC], and cord), GVHD prophylaxis (tacrolimus/methotrexate), age, hematopoietic cell transplantation-specific comorbidity index (HCT-CI), and conditioning regimen (TBI-based, chemotherapy only).
Period Title: Overall Study
STARTED2652
COMPLETED2052
NOT COMPLETED60

Baseline Characteristics

Arm/Group TitlePasireotide + Preparatory RegimenHistorical ControlsTotal
Arm/Group DescriptionEligible subjects will receive pasireotide daily for 5 days before stem cell transplant, the day of the stem cell transplant, and daily for 8 days following the stem cell transplant. Preparatory regimen will be given 4 days before stem cell transplant.Contemporaneous controls were matched using the following parameters: Transplant diagnosis (acute leukemias, lymphomas, myelodysplastic syndrome [MDS]/myeloproliferative neoplasm [MPN]/other), donor (related, unrelated), graft (bone marrow, peripheral blood progenitor cell [PBPC], and cord), GVHD prophylaxis (tacrolimus/methotrexate), age, hematopoietic cell transplantation-specific comorbidity index (HCT-CI), and conditioning regimen (TBI-based, chemotherapy only).Total of all reporting groups
Overall Participants265278
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]
58
51
52
Sex: Female, Male (Count of Participants)
Female
8
30.8%
23
44.2%
31
39.7%
Male
18
69.2%
29
55.8%
47
60.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
0
0%
1
1.9%
1
1.3%
Not Hispanic or Latino
26
100%
46
88.5%
72
92.3%
Unknown or Not Reported
0
0%
5
9.6%
5
6.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
Asian
1
3.8%
0
0%
1
1.3%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
Black or African American
2
7.7%
7
13.5%
9
11.5%
White
23
88.5%
43
82.7%
66
84.6%
More than one race
0
0%
0
0%
0
0%
Unknown or Not Reported
0
0%
2
3.8%
2
2.6%
Region of Enrollment (Count of Participants)
United States
26
100%
52
100%
78
100%

Outcome Measures

1. Primary Outcome
TitlePercentage of GI Toxicity From the Preparatory Regimen and the GVHD Prophylaxis in Stem Cell Transplantation (SCT) Patients Who Are Treated With Pasireotide
DescriptionNumber of participants who experience grades III-IV GI toxicity
Time Frame30 Days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitlePasireotide + Preparatory Regimen
Arm/Group DescriptionEligible subjects will receive pasireotide daily for 5 days before stem cell transplant, the day of the stem cell transplant, and daily for 8 days following the stem cell transplant. Preparatory regimen will be given 4 days before stem cell transplant.
Measure Participants26
Count of Participants [Participants]
21
80.8%
2. Secondary Outcome
TitlePercentage of Acute GVHD
DescriptionNumber of participants who experience acute GVHD
Time Frame100 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitlePasireotide + Preparatory Regimen
Arm/Group DescriptionEligible subjects will receive pasireotide daily for 5 days before stem cell transplant, the day of the stem cell transplant, and daily for 8 days following the stem cell transplant. Preparatory regimen will be given 4 days before stem cell transplant.
Measure Participants26
Count of Participants [Participants]
15
57.7%
3. Secondary Outcome
TitleMaximum Severity of Acute GVHD Compared to Historical Controls
DescriptionAssess maximum severity of acute GVHD scored as stage 1 (least severe) through stage 4 (most severe) using BMT CTN, 2013 standards
Time Frame100 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitlePasireotide + Preparatory Regimen
Arm/Group DescriptionEligible subjects will receive pasireotide daily for 5 days before stem cell transplant, the day of the stem cell transplant, and daily for 8 days following the stem cell transplant. Preparatory regimen will be given 4 days before stem cell transplant.
Measure Participants26
Median (Inter-Quartile Range) [units on a scale]
2
4. Secondary Outcome
TitleIncidence of Chronic GVHD Compared to Historical Controls
DescriptionMeasure the number of participants who experience chronic GVHD
Time Frame1 year

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitlePasireotide + Preparatory RegimenHistorical Controls
Arm/Group DescriptionEligible subjects will receive pasireotide daily for 5 days before stem cell transplant, the day of the stem cell transplant, and daily for 8 days following the stem cell transplant. Preparatory regimen will be given 4 days before stem cell transplant.Contemporaneous controls were matched using the following parameters: Transplant diagnosis (acute leukemias, lymphomas, myelodysplastic syndrome [MDS]/myeloproliferative neoplasm [MPN]/other), donor (related, unrelated), graft (bone marrow, peripheral blood progenitor cell [PBPC], and cord), GVHD prophylaxis (tacrolimus/methotrexate), age, hematopoietic cell transplantation-specific comorbidity index (HCT-CI), and conditioning regimen (TBI-based, chemotherapy only).
Measure Participants2652
Count of Participants [Participants]
16
61.5%
22
42.3%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pasireotide + Preparatory Regimen, Historical Controls
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesisp-Value0.12
Comments
MethodChi-squared
Comments
5. Secondary Outcome
TitleMaximum Severity of Chronic GVHD Compared to Historical Controls
DescriptionAssess maximum severity of chronic GVHD scored as none, mild, moderate or severe using 2014 NIH Consensus Criteria
Time Frame1 year

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitlePasireotide + Preparatory RegimenHistorical Controls
Arm/Group DescriptionEligible subjects will receive pasireotide daily for 5 days before stem cell transplant, the day of the stem cell transplant, and daily for 8 days following the stem cell transplant. Preparatory regimen will be given 4 days before stem cell transplant.Contemporaneous controls were matched using the following parameters: Transplant diagnosis (acute leukemias, lymphomas, myelodysplastic syndrome [MDS]/myeloproliferative neoplasm [MPN]/other), donor (related, unrelated), graft (bone marrow, peripheral blood progenitor cell [PBPC], and cord), GVHD prophylaxis (tacrolimus/methotrexate), age, hematopoietic cell transplantation-specific comorbidity index (HCT-CI), and conditioning regimen (TBI-based, chemotherapy only).
Measure Participants2652
Count of Participants [Participants]
8
30.8%
11
21.2%
6. Secondary Outcome
TitleOverall Survival Compared to Historical Controls
DescriptionRate of overall survival of participants at one year post transplant
Time Frame1 year

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitlePasireotide + Preparatory RegimenHistorical Controls
Arm/Group DescriptionEligible subjects will receive pasireotide daily for 5 days before stem cell transplant, the day of the stem cell transplant, and daily for 8 days following the stem cell transplant. Preparatory regimen will be given 4 days before stem cell transplant.Contemporaneous controls were matched using the following parameters: Transplant diagnosis (acute leukemias, lymphomas, myelodysplastic syndrome [MDS]/myeloproliferative neoplasm [MPN]/other), donor (related, unrelated), graft (bone marrow, peripheral blood progenitor cell [PBPC], and cord), GVHD prophylaxis (tacrolimus/methotrexate), age, hematopoietic cell transplantation-specific comorbidity index (HCT-CI), and conditioning regimen (TBI-based, chemotherapy only).
Measure Participants2652
Number (95% Confidence Interval) [percentage of participants]
63
242.3%
82
157.7%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pasireotide + Preparatory Regimen, Historical Controls
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesisp-Value0.006
Comments
MethodLog Rank
Comments
7. Secondary Outcome
TitleDisease Free Survival Compared to Historical Controls
DescriptionRate of disease free survival of participants at one year post transplant
Time Frame1 year

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitlePasireotide + Preparatory RegimenHistorical Controls
Arm/Group DescriptionEligible subjects will receive pasireotide daily for 5 days before stem cell transplant, the day of the stem cell transplant, and daily for 8 days following the stem cell transplant. Preparatory regimen will be given 4 days before stem cell transplant.Contemporaneous controls were matched using the following parameters: Transplant diagnosis (acute leukemias, lymphomas, myelodysplastic syndrome [MDS]/myeloproliferative neoplasm [MPN]/other), donor (related, unrelated), graft (bone marrow, peripheral blood progenitor cell [PBPC], and cord), GVHD prophylaxis (tacrolimus/methotrexate), age, hematopoietic cell transplantation-specific comorbidity index (HCT-CI), and conditioning regimen (TBI-based, chemotherapy only).
Measure Participants2652
Number (95% Confidence Interval) [percentage of participants]
40
153.8%
78
150%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pasireotide + Preparatory Regimen, Historical Controls
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesisp-Value0.002
Comments
MethodLog Rank
Comments
8. Other Pre-specified Outcome
TitleCitrulline and Fecal Calprotectin Levels Will be Measured
DescriptionExploratory outcome-These levels will be evaluated as biomarkers of GI tract health and function in SCT patients and the correlation between these biomarkers and GI toxicity.
Time Frame100 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
9. Other Pre-specified Outcome
TitleEvaluate GI Toxicity Assessment by Video Capsule Endoscopy.
DescriptionExploratory outcome-Video capsule endoscopy will be performed in a subset of ten study participants on the last day study drug is administered. Images will be examined for evidence of the four following types of abnormalities: reddened/edema/villous blunting, erosion, ulcer and stenosis.
Time Frame14 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description

Adverse Events

Time FrameAEs were reported from the day Pasireotide started to day 30 after transplant (Day +30).
Adverse Event Reporting Description Adverse event collection is not applicable for historical controls. Adverse events after Day 30 were not expected to be related to the intervention. However, HCT is a fraught process, with significant morbidity, and 10-20% of patients die from transplant-related complications. To determine if the study intervention would improve survival, overall survival was collected at year 1 (efficacy) and adverse events between Day 30-Year 1 were not collected.
Arm/Group TitlePasireotide + Preparatory RegimenHistorical Controls
Arm/Group DescriptionEligible subjects will receive pasireotide daily for 5 days before stem cell transplant, the day of the stem cell transplant, and daily for 8 days following the stem cell transplant. Preparatory regimen will be given 4 days before stem cell transplant.Contemporaneous controls were matched using the following parameters: Transplant diagnosis (acute leukemias, lymphomas, myelodysplastic syndrome [MDS]/myeloproliferative neoplasm [MPN]/other), donor (related, unrelated), graft (bone marrow, peripheral blood progenitor cell [PBPC], and cord), GVHD prophylaxis (tacrolimus/methotrexate), age, hematopoietic cell transplantation-specific comorbidity index (HCT-CI), and conditioning regimen (TBI-based, chemotherapy only).
All Cause Mortality
Pasireotide + Preparatory RegimenHistorical Controls
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total1/26 (3.8%) 0/0 (NaN)
Serious Adverse Events
Pasireotide + Preparatory RegimenHistorical Controls
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total8/26 (30.8%) 0/0 (NaN)
Cardiac disorders
Mobitz - Type II AV Block1/26 (3.8%) 1/0 (Infinity)
Gastrointestinal disorders
Enterocolitis1/26 (3.8%) 1/0 (Infinity)
Hepatobiliary disorders
VOD1/26 (3.8%) 1/0 (Infinity)
Infections and infestations
Febrile Neutropenia2/26 (7.7%) 2/0 (Infinity)
Infections and infestations - Other, specify; blood stream1/26 (3.8%) 1/0 (Infinity)
Lung infection1/26 (3.8%) 1/0 (Infinity)
Nervous system disorders
Somnolence1/26 (3.8%) 1/0 (Infinity)
Other (Not Including Serious) Adverse Events
Pasireotide + Preparatory RegimenHistorical Controls
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total26/26 (100%) 0/0 (NaN)
Blood and lymphatic system disorders
Hematoma0/26 (0%) 0/0 (NaN)
Thromboembolic event1/26 (3.8%) 1/0 (Infinity)
Cardiac disorders
Afib0/26 (0%) 0/0 (NaN)
Sinus Bradycardia7/26 (26.9%) 7/0 (Infinity)
2nd deg AVB1/26 (3.8%) 1/0 (Infinity)
Myocardial Infarction0/26 (0%) 0/0 (NaN)
Pericardial effusion1/26 (3.8%) 1/0 (Infinity)
Pulmonary Edema4/26 (15.4%) 4/0 (Infinity)
Endocrine disorders
Hyperglycemia12/26 (46.2%) 12/0 (Infinity)
Eye disorders
Dry Eyes2/26 (7.7%) 2/0 (Infinity)
Floaters0/26 (0%) 0/0 (NaN)
Gastrointestinal disorders
Abdominal Pain14/26 (53.8%) 14/0 (Infinity)
Anorexia21/26 (80.8%) 21/0 (Infinity)
Bloating5/26 (19.2%) 5/0 (Infinity)
Constipation8/26 (30.8%) 8/0 (Infinity)
Diarrhea24/26 (92.3%) 24/0 (Infinity)
Dysphagia1/26 (3.8%) 1/0 (Infinity)
Dyspepsia5/26 (19.2%) 5/0 (Infinity)
Dysgeusia9/26 (34.6%) 9/0 (Infinity)
Mucositis24/26 (92.3%) 24/0 (Infinity)
Ileus2/26 (7.7%) 2/0 (Infinity)
Nausea25/26 (96.2%) 25/0 (Infinity)
Vomiting20/26 (76.9%) 20/0 (Infinity)
Bowel Obstruction1/26 (3.8%) 1/0 (Infinity)
General disorders
Chills1/26 (3.8%) 1/0 (Infinity)
Chest pain2/26 (7.7%) 2/0 (Infinity)
Epistaxis2/26 (7.7%) 2/0 (Infinity)
Bone Pain1/26 (3.8%) 1/0 (Infinity)
Dehydration1/26 (3.8%) 1/0 (Infinity)
Fatigue20/26 (76.9%) 20/0 (Infinity)
Fracture1/26 (3.8%) 1/0 (Infinity)
Hiccups0/26 (0%) 0/0 (NaN)
Insomnia4/26 (15.4%) 4/0 (Infinity)
Myalgias0/26 (0%) 0/0 (NaN)
Nasal Congestion8/26 (30.8%) 8/0 (Infinity)
Pain in Extremity1/26 (3.8%) 1/0 (Infinity)
Pruritis2/26 (7.7%) 2/0 (Infinity)
Menorrhagia0/26 (0%) 0/0 (NaN)
Rhinorrhea3/26 (11.5%) 3/0 (Infinity)
Toe Trauma1/26 (3.8%) 1/0 (Infinity)
Hepatobiliary disorders
VOD1/26 (3.8%) 1/0 (Infinity)
AST Elevation2/26 (7.7%) 2/0 (Infinity)
ALT Elevation2/26 (7.7%) 2/0 (Infinity)
Alk Phos Elevation1/26 (3.8%) 1/0 (Infinity)
Bilirubin Elevation6/26 (23.1%) 6/0 (Infinity)
Immune system disorders
Allergic reaction2/26 (7.7%) 2/0 (Infinity)
Infusion Reaction3/26 (11.5%) 3/0 (Infinity)
Infections and infestations
Enterocolitis5/26 (19.2%) 5/0 (Infinity)
Febrile Neutropenia17/26 (65.4%) 17/0 (Infinity)
Fever4/26 (15.4%) 4/0 (Infinity)
HSV Reactivation3/26 (11.5%) 3/0 (Infinity)
Lung Infection4/26 (15.4%) 4/0 (Infinity)
Otitis Media1/26 (3.8%) 1/0 (Infinity)
Joint Infection0/26 (0%) 0/0 (NaN)
Skin Infection3/26 (11.5%) 3/0 (Infinity)
Catheter-Related Infection6/26 (23.1%) 6/0 (Infinity)
Sinusitis0/26 (0%) 0/0 (NaN)
Sepsis7/26 (26.9%) 7/0 (Infinity)
Thrush4/26 (15.4%) 4/0 (Infinity)
UTI2/26 (7.7%) 2/0 (Infinity)
Viremia4/26 (15.4%) 4/0 (Infinity)
Metabolism and nutrition disorders
Hyperkalemia3/26 (11.5%) 3/0 (Infinity)
Hypernatremia1/26 (3.8%) 1/0 (Infinity)
Hyponatremia1/26 (3.8%) 1/0 (Infinity)
Nervous system disorders
Encephalopathy6/26 (23.1%) 6/0 (Infinity)
Hallucination3/26 (11.5%) 3/0 (Infinity)
Headache11/26 (42.3%) 11/0 (Infinity)
Intracranial Hemorrhage0/26 (0%) 0/0 (NaN)
Peripheral Sensory Neuropathy2/26 (7.7%) 2/0 (Infinity)
PRES0/26 (0%) 0/0 (NaN)
Psychiatric disorders
Anxiety7/26 (26.9%) 7/0 (Infinity)
Renal and urinary disorders
Inreased Creatinine5/26 (19.2%) 5/0 (Infinity)
Acute Kidney Injury0/26 (0%) 0/0 (NaN)
Dysuria6/26 (23.1%) 6/0 (Infinity)
Bladder Spasm1/26 (3.8%) 1/0 (Infinity)
Hematuria1/26 (3.8%) 1/0 (Infinity)
Prostatic Obstruction1/26 (3.8%) 1/0 (Infinity)
Urinary incontinence1/26 (3.8%) 1/0 (Infinity)
Urinary Retention3/26 (11.5%) 3/0 (Infinity)
Respiratory, thoracic and mediastinal disorders
Cough8/26 (30.8%) 8/0 (Infinity)
Dyspnea7/26 (26.9%) 7/0 (Infinity)
URI1/26 (3.8%) 1/0 (Infinity)
Hemoptysis1/26 (3.8%) 1/0 (Infinity)
Hypoxia7/26 (26.9%) 7/0 (Infinity)
Pleural Effusion1/26 (3.8%) 1/0 (Infinity)
Pneumonitis0/26 (0%) 0/0 (NaN)
Skin and subcutaneous tissue disorders
Dry Skin2/26 (7.7%) 2/0 (Infinity)
Folliculitis0/26 (0%) 0/0 (NaN)
Acne Rash1/26 (3.8%) 1/0 (Infinity)
Rash19/26 (73.1%) 19/0 (Infinity)
Vascular disorders
Hypertension14/26 (53.8%) 14/0 (Infinity)
Hypotension5/26 (19.2%) 5/0 (Infinity)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/TitleAnthony Sung
OrganizationDuke University
Phone919-668-1000
Emailanthony.sung@duke.edu
Responsible Party:
Anthony Sung, MD, Professor of Medicine, Duke University
ClinicalTrials.gov Identifier:
NCT02215070
Other Study ID Numbers:
  • Pro00051736
First Posted:
Aug 13, 2014
Last Update Posted:
Nov 17, 2021
Last Verified:
Oct 1, 2021