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A Study Evaluating Ultratrace Iobenguane I131 in Patients With Malignant Relapsed/Refractory Pheochromocytoma/Paraganglioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00874614
Recruitment Status : Active, not recruiting
First Posted : April 2, 2009
Results First Posted : October 5, 2018
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Molecular Insight Pharmaceuticals, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Pheochromocytoma
Paraganglioma
Intervention Radiation: Ultratrace® Iobenguane I131
Enrollment 74
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AZEDRA® (Iobenguane I 131)
Hide Arm/Group Description Patients received dosimetric dose (~5 mCi) of AZEDRA® via intravenous injection to confirm iobenguane-avidity and to establish dosimetry and biodistribution assessment. Eligible patients received a therapeutic dose of AZEDRA® based on body weight and reduced, if necessary, based on the dosimetry data. The second therapeutic dose is administered intravenously at least 90 days later.
Period Title: Overall Study
Started 74
Received at Least One Therapeutic Dose 68
Received Two Therapeutic Doses 50
Completed [1] 16 [2]
Not Completed 58
[1]
Completed or continuing in long-term follow-up phase
[2]
As of December 2017
Arm/Group Title AZEDRA® (Iobenguane I 131)
Hide Arm/Group Description Patients received dosimetric dose (~5 mCi) of AZEDRA® via intravenous injection to confirm iobenguane-avidity and to establish dosimetry and biodistribution assessment. Eligible patients received a therapeutic dose of AZEDRA® based on body weight and reduced, if necessary, based on the dosimetry data. The second therapeutic dose is administered intravenously at least 90 days later.
Overall Number of Baseline Participants 68
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 68 participants
55
(16 to 72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants
Female
39
  57.4%
Male
29
  42.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants
American Indian or Alaska Native
0
   0.0%
Asian
3
   4.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
14
  20.6%
White
51
  75.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Percentage of Patients Who Experienced a 50% or Greater Reduction (Including Discontinuation) of All Antihypertensive Medication(s) Lasting for at Least Six Months.
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZEDRA® (Iobenguane I 131)
Hide Arm/Group Description:
Patients received at least one therapeutic dose of AZEDRA®.
Overall Number of Participants Analyzed 68
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
25
(16 to 37)
2.Secondary Outcome
Title Best Confirmed Overall Tumor Response of Complete Response (CR) or Partial Response (PR) by RECIST 1.0.
Hide Description Response Evaluation Criteria In Solid Tumors (RECIST) 1.0 was assessed by two independent central reviewers and one adjudicator, and overall response (PR or CR) was confirmed by follow-up imaging at the subsequent timepoint. Complete response was defined as confirmed disappearance of all target lesions and Partial Response was defined as confirmed decreased of >= 30% in baseline sum of the longest diameter of target lesions.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 64 patients with tumor measurements evaluable for tumor response.
Arm/Group Title AZEDRA® (Iobenguane I 131)
Hide Arm/Group Description:
Patients received at least one therapeutic dose of AZEDRA®.
Overall Number of Participants Analyzed 64
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
23.4
(15 to 35)
3.Secondary Outcome
Title Changes From Baseline in Overall Quality of Life (QoL) - Best Response Within 12 Months After First Therapeutic Dose of AZEDRA®.
Hide Description The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 v.3 was used to evaluate QoL. This questionnaire was comprised of 30 questions, two of which pertain to a patient's Global Health Status and QoL. The two questions used a 7-point Likert scale of 1 (very poor) to 7 (excellent), in which the scores were averaged and linearly transformed to a 0-100 scale with higher scores indicating better health status and QoL. The questionnaire was administered at baseline and through 12 months after the first therapeutic dose of AZEDRA®. The results of QoL and changes from baseline were summarized by visit and the best response within 12 months after first therapeutic dose of AZEDRA® was reported. The outcome represents the mean change from baseline in overall QoL based on the best response reported within 12 months after first therapeutic dose of AZEDRA®.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
53 patients with data available.
Arm/Group Title AZEDRA® (Iobenguane I 131)
Hide Arm/Group Description:
Patients received at least one therapeutic dose of AZEDRA®.
Overall Number of Participants Analyzed 53
Mean (Standard Deviation)
Unit of Measure: score on a scale
17.5  (18.12)
4.Secondary Outcome
Title Overall Survival
Hide Description Duration of overall survival was calculated from the date of first therapeutic dose of AZEDRA® to death, or at the last date the patient was known to be alive. Results are presented per December 2017 data-cut. Survival was censored at the end of the 5-year long-term follow-up period, thus the upper limit of the confidence interval reported below for two therapeutic doses is actually >60 months.
Time Frame Up to 5 Years (60 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title At Least One Therapeutic Dose of AZEDRA® Two Therapeutic Doses of AZEDRA®
Hide Arm/Group Description:
Patients received at least one therapeutic dose of AZEDRA®.
Patients received two therapeutic doses of AZEDRA®.
Overall Number of Participants Analyzed 68 50
Median (95% Confidence Interval)
Unit of Measure: months
37
(31 to 49)
44
(32 to 60)
Time Frame All adverse events were collected from time of signed informed consent until the end of 15 weeks after the last therapeutic dose of AZEDRA®. Serious adverse events and adverse events of special interest were collected as part of long-term follow-up.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AZEDRA® (Iobenguane I 131)
Hide Arm/Group Description Patients who received any dose of AZEDRA® (N=74). All-cause mortality was followed in patients who received at least one therapeutic dose of AZEDRA® (N=68), up through long-term follow-up as of December 2017.
All-Cause Mortality
AZEDRA® (Iobenguane I 131)
Affected / at Risk (%)
Total   31/68 (45.59%) 
Show Serious Adverse Events Hide Serious Adverse Events
AZEDRA® (Iobenguane I 131)
Affected / at Risk (%)
Total   32/74 (43.24%) 
Blood and lymphatic system disorders   
Thrombocytopenia   12/74 (16.22%) 
Anemia   4/74 (5.41%) 
Febrile neutropenia   3/74 (4.05%) 
Leukopenia   3/74 (4.05%) 
Neutropenia   3/74 (4.05%) 
Sickle cell anemia with crisis   1/74 (1.35%) 
Cardiac disorders   
Cardiomyopathy   1/74 (1.35%) 
Tachycardia   1/74 (1.35%) 
Endocrine disorders   
Hypothyroidism   1/74 (1.35%) 
Gastrointestinal disorders   
Constipation   2/74 (2.70%) 
Abdominal pain   1/74 (1.35%) 
Diarrhea   1/74 (1.35%) 
Intestinal perforation   1/74 (1.35%) 
General disorders   
Disease progression   1/74 (1.35%) 
Hepatobiliary disorders   
Cholangitis acute   1/74 (1.35%) 
Infections and infestations   
Cellulitis   1/74 (1.35%) 
Sepsis   1/74 (1.35%) 
Injury, poisoning and procedural complications   
Radius fracture   1/74 (1.35%) 
Tendon injury   1/74 (1.35%) 
Investigations   
Aspartate aminotransferase increased   1/74 (1.35%) 
Platelet count decreased   1/74 (1.35%) 
Metabolism and nutrition disorders   
Dehydration   1/74 (1.35%) 
Musculoskeletal and connective tissue disorders   
Pathological fracture   1/74 (1.35%) 
Spinal instability   1/74 (1.35%) 
Nervous system disorders   
Convulsion   1/74 (1.35%) 
Dyskinesia   1/74 (1.35%) 
Seizure   1/74 (1.35%) 
Spinal cord compression   1/74 (1.35%) 
Psychiatric disorders   
Mental status changes   1/74 (1.35%) 
Suicide attempt   1/74 (1.35%) 
Renal and urinary disorders   
Acute kidney injury   1/74 (1.35%) 
Hydronephrosis   1/74 (1.35%) 
Kidney fibrosis   1/74 (1.35%) 
Renal failure acute   1/74 (1.35%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea   3/74 (4.05%) 
Pulmonary embolism   2/74 (2.70%) 
Pleural effusion   1/74 (1.35%) 
Pneumothorax   1/74 (1.35%) 
Pulmonary edema   1/74 (1.35%) 
Vascular disorders   
Hypertensive crisis   1/74 (1.35%) 
Hypotension   1/74 (1.35%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AZEDRA® (Iobenguane I 131)
Affected / at Risk (%)
Total   69/74 (93.24%) 
Blood and lymphatic system disorders   
Thrombocytopenia   49/74 (66.22%) 
Anemia   43/74 (58.11%) 
Leukopenia   41/74 (55.41%) 
Neutropenia   39/74 (52.70%) 
Lymphopenia   10/74 (13.51%) 
Cardiac disorders   
Tachycardia   7/74 (9.46%) 
Palpitations   8/74 (10.81%) 
Gastrointestinal disorders   
Nausea   53/74 (71.62%) 
Vomiting   36/74 (48.65%) 
Dry mouth   28/74 (37.84%) 
Constipation   16/74 (21.62%) 
Diarrhea   16/74 (21.62%) 
Abdominal pain   14/74 (18.92%) 
Retching   4/74 (5.41%) 
Salivary gland pain   10/74 (13.51%) 
Dyspepsia   8/74 (10.81%) 
Abdominal distension   5/74 (6.76%) 
Dysphagia   4/74 (5.41%) 
General disorders   
Fatigue   41/74 (55.41%) 
Asthenia   14/74 (18.92%) 
Pyrexia   9/74 (12.16%) 
Edema peripheral   9/74 (12.16%) 
Infusion site pain   6/74 (8.11%) 
Injection site pain   6/74 (8.11%) 
Chills   5/74 (6.76%) 
Chest pain   4/74 (5.41%) 
Infections and infestations   
Sialoadenitis   14/74 (18.92%) 
Urinary tract infection   8/74 (10.81%) 
Candida infection   5/74 (6.76%) 
Upper respiratory tract infection   5/74 (6.76%) 
Nasopharyngitis   4/74 (5.41%) 
Sinusitis   4/74 (5.41%) 
Injury, poisoning and procedural complications   
Contusion   4/74 (5.41%) 
Investigations   
White blood cell count decreased   12/74 (16.22%) 
International normalized ratio increased   11/74 (14.86%) 
Neutrophil count decreased   10/74 (13.51%) 
Aspartate aminotransferase increased   9/74 (12.16%) 
Hemoglobin decreased   7/74 (9.46%) 
Platelet count decreased   6/74 (8.11%) 
Alanine aminotransferase increased   5/74 (6.76%) 
Weight decreased   11/74 (14.86%) 
Prothrombin time prolonged   8/74 (10.81%) 
Lymphocyte count decreased   6/74 (8.11%) 
Blood alkaline phosphatase increased   5/74 (6.76%) 
Blood creatinine increased   5/74 (6.76%) 
Red blood cell count decreased   5/74 (6.76%) 
Hematocrit decreased   4/74 (5.41%) 
Metabolism and nutrition disorders   
Decreased appetite   17/74 (22.97%) 
Dehydration   9/74 (12.16%) 
Hypocalcemia   4/74 (5.41%) 
Hypokalemia   4/74 (5.41%) 
Musculoskeletal and connective tissue disorders   
Back pain   10/74 (13.51%) 
Pain in extremity   9/74 (12.16%) 
Neck pain   6/74 (8.11%) 
Arthralgia   5/74 (6.76%) 
Myalgia   4/74 (5.41%) 
Nervous system disorders   
Dizziness   28/74 (37.84%) 
Headache   21/74 (28.38%) 
Syncope   4/74 (5.41%) 
Dysgeusia   13/74 (17.57%) 
Paraesthesia   4/74 (5.41%) 
Psychiatric disorders   
Insomnia   7/74 (9.46%) 
Anxiety   4/74 (5.41%) 
Renal and urinary disorders   
Proteinuria   6/74 (8.11%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea   14/74 (18.92%) 
Pleural effusion   4/74 (5.41%) 
Cough   11/74 (14.86%) 
Oropharyngeal pain   10/74 (13.51%) 
Epistaxis   4/74 (5.41%) 
Nasal congestion   4/74 (5.41%) 
Skin and subcutaneous tissue disorders   
Petechiae   6/74 (8.11%) 
Hyperhidrosis   8/74 (10.81%) 
Dry skin   7/74 (9.46%) 
Alopecia   4/74 (5.41%) 
Dermatitis contact   4/74 (5.41%) 
Vascular disorders   
Hypotension   18/74 (24.32%) 
Hypertension   13/74 (17.57%) 
Orthostatic hypotension   8/74 (10.81%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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/Title: Jessica D Jensen, MPH
Organization: Progenics Pharmaceuticals, Inc
Phone: 646-975-2513
Responsible Party: Molecular Insight Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00874614     History of Changes
Other Study ID Numbers: MIP-IB12B
First Submitted: April 1, 2009
First Posted: April 2, 2009
Results First Submitted: August 22, 2018
Results First Posted: October 5, 2018
Last Update Posted: October 5, 2018