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Trial record 87 of 2732 for:    Neoplasms | Neuroendocrine Tumors

AMG 479 in Advanced Carcinoid and Pancreatic Neuroendocrine Tumors

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: NCT01024387
Recruitment Status : Completed
First Posted : December 2, 2009
Results First Posted : December 27, 2017
Last Update Posted : March 8, 2018
Sponsor:
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
H. Lee Moffitt Cancer Center and Research Institute
Amgen
Information provided by (Responsible Party):
Matthew H. Kulke, MD, Dana-Farber Cancer Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Neuroendocrine Tumor
Carcinoid Tumor
Pancreatic Neuroendocrine Tumor
Intervention Drug: AMG 479
Enrollment 60
Recruitment Details Patients enrolled from June 2010 through June 2011.
Pre-assignment Details  
Arm/Group Title AMG 479
Hide Arm/Group Description Patients receive AMG 479 at a dose of 18 mg/kg administered IV on day 1 (± 3 days) of every 3-week cycle. Treatment should continue until disease progression, unacceptable toxicity or withdrawal of consent.
Period Title: Overall Study
Started 60
Evaluable for PFS [1] 54
Evaluable for Response [2] 53
Completed [3] 0
Not Completed 60
Reason Not Completed
Radiographic Progression             29
Symptomatic Progression             10
Physician Decision             5
Withdrawal by Subject             5
Death             2
Prolonged Treatment Delay             1
Adverse Event             3
Other             5
[1]
One of the patients uneval for resp was incl in PFS eval dataset which included follow-up for death.
[2]
symptomatic deterioration (n=2), patient or MD decision (n=2 each), hypersensitivity reaction (n=1)
[3]
Given treatment duration is not fixed, all patients are considered as ‘Non Completed’.
Arm/Group Title AMG 479
Hide Arm/Group Description Patients receive AMG 479 at a dose of 18 mg/kg administered IV on day 1 (± 3 days) of every 3-week cycle. Treatment should continue until disease progression, unacceptable toxicity or withdrawal of consent.
Overall Number of Baseline Participants 60
Hide Baseline Analysis Population Description
The analysis dataset is comprised of all enrolled patients.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 60 participants
61
(30 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Female
38
  63.3%
Male
22
  36.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 60 participants
60
 100.0%
1.Primary Outcome
Title Objective Response Rate
Hide Description Objective response rate is the percentage of patients achieving partial response (PR) or complete response (CR) per RECIST 1.0 criteria. For target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. CR or PR status must be confirmed by repeat assessments performed no fewer than 4 weeks or more than 6 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
Time Frame Disease was evaluated radiologically at baseline, every 3 cycles (9 weeks) on treatment and at end of treatment. Patients in this study cohort received a median of 6 treatment cycles (18 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis dataset is comprised of all response evaluable patients.
Arm/Group Title AMG 479
Hide Arm/Group Description:
Patients receive AMG 479 at a dose of 18 mg/kg administered IV on day 1 (± 3 days) of every 3-week cycle. Treatment should continue until disease progression, unacceptable toxicity or withdrawal of consent.
Overall Number of Participants Analyzed 53
Measure Type: Number
Unit of Measure: percentage of patients
0.0
2.Secondary Outcome
Title Duration of Response
Hide Description The duration of response is measured from the time measurement criteria are met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).
Time Frame Disease was evaluated radiologically at baseline, every 3 cycles (9 weeks) on treatment and at end of treatment. Patients in this study cohort received a median of 6 treatment cycles (18 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
This endpoint was not evaluated because zero patients achieved objected response per RECIST criteria.
Arm/Group Title AMG 479
Hide Arm/Group Description:
Patients receive AMG 479 at a dose of 18 mg/kg administered IV on day 1 (± 3 days) of every 3-week cycle. Treatment should continue until disease progression, unacceptable toxicity or withdrawal of consent.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Grade 3-4 Toxicity Rate
Hide Description Grade 3-4 toxicity rate is the percentage of patients who experienced a grade 3 or 4 adverse event with treatment attribution of possible, probable or definite based on CTCAEv4.
Time Frame Toxicity was evaluated every cycle (3 weeks) on treatment. Patients in this study cohort received a median of 6 treatment cycles (18 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis dataset is comprised of all enrolled patients.
Arm/Group Title AMG 479
Hide Arm/Group Description:
Patients receive AMG 479 at a dose of 18 mg/kg administered IV on day 1 (± 3 days) of every 3-week cycle. Treatment should continue until disease progression, unacceptable toxicity or withdrawal of consent.
Overall Number of Participants Analyzed 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
31.7
(22.3 to 45.0)
4.Secondary Outcome
Title Progression Free Survival
Hide Description Progression-free survival (PFS) based on the Kaplan-Meier method is defined as the time from the start of treatment to the date of the first documented disease progression or death due to any cause. Patients without an event were censored at the earliest date of last disease assessment or initiation of non-protocol anti-cancer therapy. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.
Time Frame Disease was evaluated radiologically at baseline, every 3 cycles (9 weeks) on treatment and at end of treatment. Patients in this study cohort were followed up to 20 months.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis dataset is comprised of all PFS evaluable patients.
Arm/Group Title AMG 479
Hide Arm/Group Description:
Patients receive AMG 479 at a dose of 18 mg/kg administered IV on day 1 (± 3 days) of every 3-week cycle. Treatment should continue until disease progression, unacceptable toxicity or withdrawal of consent.
Overall Number of Participants Analyzed 54
Median (95% Confidence Interval)
Unit of Measure: months
6.3
(4.2 to 12.6)
5.Secondary Outcome
Title 1-Year Overall Survival
Hide Description Overall survival (OS) based on the Kaplan-Meier method is defined as the time from treatment start to the date of death or censored at the date last known alive. 1-year overall survival is the probability (%) of remaining alive 1 year from the start of treatment.
Time Frame Patients in this study cohort were followed up to 20 months.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis dataset is comprised of all enrolled patients.
Arm/Group Title AMG 479
Hide Arm/Group Description:
Patients receive AMG 479 at a dose of 18 mg/kg administered IV on day 1 (± 3 days) of every 3-week cycle. Treatment should continue until disease progression, unacceptable toxicity or withdrawal of consent.
Overall Number of Participants Analyzed 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent probability
66
(52 to 77)
Time Frame Adverse events (AEs) were evaluated every cycle (3 weeks) on treatment. Patients in this study cohort received a median of 6 treatment cycles (18 weeks).
Adverse Event Reporting Description Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
 
Arm/Group Title AMG 479
Hide Arm/Group Description Patients receive AMG 479 at a dose of 18 mg/kg administered IV on day 1 (± 3 days) of every 3-week cycle. Treatment should continue until disease progression, unacceptable toxicity or withdrawal of consent.
All-Cause Mortality
AMG 479
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
AMG 479
Affected / at Risk (%)
Total   19/60 (31.67%) 
Blood and lymphatic system disorders   
Anemia  1  1/60 (1.67%) 
Gastrointestinal disorders   
Abdominal pain  1  2/60 (3.33%) 
General disorders   
Death NOS  1  1/60 (1.67%) 
Infusion related reaction  1  1/60 (1.67%) 
Infections and infestations   
Lung infection  1  2/60 (3.33%) 
Infections and infestations - Other, specify  1  2/60 (3.33%) 
Investigations   
Alkaline phosphatase increased  1  3/60 (5.00%) 
Lymphocyte count decreased  1  4/60 (6.67%) 
Neutrophil count decreased  1  2/60 (3.33%) 
Platelet count decreased  1  3/60 (5.00%) 
Metabolism and nutrition disorders   
Anorexia  1  1/60 (1.67%) 
Hyperglycemia  1  9/60 (15.00%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/60 (1.67%) 
Myalgia  1  1/60 (1.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
AMG 479
Affected / at Risk (%)
Total   57/60 (95.00%) 
Blood and lymphatic system disorders   
Anemia  1  21/60 (35.00%) 
Febrile neutropenia  1  1/60 (1.67%) 
Leukocytosis  1  1/60 (1.67%) 
Spleen disorder  1  1/60 (1.67%) 
Cardiac disorders   
Atrial flutter  1  1/60 (1.67%) 
Chest pain - cardiac  1  1/60 (1.67%) 
Palpitations  1  4/60 (6.67%) 
Ear and labyrinth disorders   
Hearing impaired  1  1/60 (1.67%) 
Ear and labyrinth disorders - Other, specify  1  1/60 (1.67%) 
Endocrine disorders   
Cushingoid  1  1/60 (1.67%) 
Eye disorders   
Blurred vision  1  1/60 (1.67%) 
Dry eye  1  1/60 (1.67%) 
Eye disorders - Other, specify  1  1/60 (1.67%) 
Gastrointestinal disorders   
Abdominal distension  1  5/60 (8.33%) 
Abdominal pain  1  22/60 (36.67%) 
Anal pain  1  2/60 (3.33%) 
Ascites  1  1/60 (1.67%) 
Bloating  1  3/60 (5.00%) 
Cecal hemorrhage  1  1/60 (1.67%) 
Colitis  1  3/60 (5.00%) 
Colonic obstruction  1  1/60 (1.67%) 
Constipation  1  13/60 (21.67%) 
Diarrhea  1  15/60 (25.00%) 
Dry mouth  1  4/60 (6.67%) 
Duodenal hemorrhage  1  1/60 (1.67%) 
Dyspepsia  1  3/60 (5.00%) 
Dysphagia  1  1/60 (1.67%) 
Flatulence  1  6/60 (10.00%) 
Gastric fistula  1  1/60 (1.67%) 
Gastritis  1  1/60 (1.67%) 
Gastroesophageal reflux disease  1  2/60 (3.33%) 
Gastrointestinal pain  1  1/60 (1.67%) 
Hemorrhoidal hemorrhage  1  1/60 (1.67%) 
Hemorrhoids  1  1/60 (1.67%) 
Ileus  1  1/60 (1.67%) 
Lower gastrointestinal hemorrhage  1  3/60 (5.00%) 
Malabsorption  1  1/60 (1.67%) 
Mucositis oral  1  3/60 (5.00%) 
Nausea  1  21/60 (35.00%) 
Obstruction gastric  1  1/60 (1.67%) 
Pancreatitis  1  1/60 (1.67%) 
Rectal fistula  1  1/60 (1.67%) 
Rectal hemorrhage  1  2/60 (3.33%) 
Rectal pain  1  1/60 (1.67%) 
Small intestinal obstruction  1  1/60 (1.67%) 
Toothache  1  1/60 (1.67%) 
Vomiting  1  12/60 (20.00%) 
Gastrointestinal disorders - Other, specify  1  3/60 (5.00%) 
General disorders   
Chills  1  10/60 (16.67%) 
Death NOS  1  1/60 (1.67%) 
Edema face  1  1/60 (1.67%) 
Edema limbs  1  5/60 (8.33%) 
Fatigue  1  34/60 (56.67%) 
Fever  1  9/60 (15.00%) 
Flu like symptoms  1  1/60 (1.67%) 
Hypothermia  1  1/60 (1.67%) 
Infusion related reaction  1  8/60 (13.33%) 
Irritability  1  1/60 (1.67%) 
Malaise  1  6/60 (10.00%) 
Non-cardiac chest pain  1  2/60 (3.33%) 
Pain  1  5/60 (8.33%) 
Sudden death NOS  1  1/60 (1.67%) 
General disorders and administration site conditions - Other, specify  1  7/60 (11.67%) 
Immune system disorders   
Allergic reaction  1  3/60 (5.00%) 
Infections and infestations   
Abdominal infection  1  1/60 (1.67%) 
Anorectal infection  1  2/60 (3.33%) 
Bronchial infection  1  1/60 (1.67%) 
Eye infection  1  1/60 (1.67%) 
Lung infection  1  1/60 (1.67%) 
Sepsis  1  2/60 (3.33%) 
Sinusitis  1  1/60 (1.67%) 
Skin infection  1  1/60 (1.67%) 
Tooth infection  1  1/60 (1.67%) 
Upper respiratory infection  1  4/60 (6.67%) 
Urinary tract infection  1  4/60 (6.67%) 
Infections and infestations - Other, specify  1  3/60 (5.00%) 
Injury, poisoning and procedural complications   
Bruising  1  2/60 (3.33%) 
Burn  1  2/60 (3.33%) 
Fall  1  2/60 (3.33%) 
Investigations   
Activated partial thromboplastin time prolonged  1  2/60 (3.33%) 
Alanine aminotransferase increased  1  8/60 (13.33%) 
Alkaline phosphatase increased  1  10/60 (16.67%) 
Aspartate aminotransferase increased  1  12/60 (20.00%) 
Blood bilirubin increased  1  6/60 (10.00%) 
Creatinine increased  1  3/60 (5.00%) 
INR increased  1  3/60 (5.00%) 
Lymphocyte count decreased  1  8/60 (13.33%) 
Neutrophil count decreased  1  7/60 (11.67%) 
Platelet count decreased  1  15/60 (25.00%) 
Weight loss  1  10/60 (16.67%) 
White blood cell decreased  1  6/60 (10.00%) 
Investigations - Other, specify  1  1/60 (1.67%) 
Metabolism and nutrition disorders   
Alcohol intolerance  1  1/60 (1.67%) 
Anorexia  1  16/60 (26.67%) 
Dehydration  1  10/60 (16.67%) 
Hypercalcemia  1  4/60 (6.67%) 
Hyperglycemia  1  24/60 (40.00%) 
Hyperkalemia  1  5/60 (8.33%) 
Hypermagnesemia  1  1/60 (1.67%) 
Hypernatremia  1  4/60 (6.67%) 
Hypertriglyceridemia  1  1/60 (1.67%) 
Hypoalbuminemia  1  6/60 (10.00%) 
Hypocalcemia  1  8/60 (13.33%) 
Hypoglycemia  1  6/60 (10.00%) 
Hypokalemia  1  8/60 (13.33%) 
Hypomagnesemia  1  4/60 (6.67%) 
Hyponatremia  1  12/60 (20.00%) 
Hypophosphatemia  1  1/60 (1.67%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  3/60 (5.00%) 
Back pain  1  10/60 (16.67%) 
Bone pain  1  1/60 (1.67%) 
Buttock pain  1  1/60 (1.67%) 
Chest wall pain  1  1/60 (1.67%) 
Flank pain  1  1/60 (1.67%) 
Generalized muscle weakness  1  4/60 (6.67%) 
Muscle weakness lower limb  1  1/60 (1.67%) 
Muscle weakness upper limb  1  1/60 (1.67%) 
Myalgia  1  7/60 (11.67%) 
Neck pain  1  2/60 (3.33%) 
Pain in extremity  1  5/60 (8.33%) 
Musculoskeletal and connective tissue disorder - Other, specify  1  2/60 (3.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumor pain  1  1/60 (1.67%) 
Nervous system disorders   
Dizziness  1  3/60 (5.00%) 
Headache  1  5/60 (8.33%) 
Lethargy  1  1/60 (1.67%) 
Paresthesia  1  1/60 (1.67%) 
Peripheral sensory neuropathy  1  1/60 (1.67%) 
Presyncope  1  2/60 (3.33%) 
Nervous system disorders - Other, specify  1  2/60 (3.33%) 
Psychiatric disorders   
Anxiety  1  7/60 (11.67%) 
Confusion  1  3/60 (5.00%) 
Delirium  1  1/60 (1.67%) 
Depression  1  6/60 (10.00%) 
Insomnia  1  11/60 (18.33%) 
Psychiatric disorders - Other, specify  1  3/60 (5.00%) 
Renal and urinary disorders   
Acute kidney injury  1  1/60 (1.67%) 
Hematuria  1  1/60 (1.67%) 
Proteinuria  1  2/60 (3.33%) 
Urinary frequency  1  1/60 (1.67%) 
Urinary incontinence  1  1/60 (1.67%) 
Urinary retention  1  1/60 (1.67%) 
Reproductive system and breast disorders   
Erectile dysfunction  1  1/60 (1.67%) 
Pelvic pain  1  2/60 (3.33%) 
Uterine pain  1  1/60 (1.67%) 
Vaginal discharge  1  1/60 (1.67%) 
Vaginal hemorrhage  1  1/60 (1.67%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  5/60 (8.33%) 
Dyspnea  1  7/60 (11.67%) 
Epistaxis  1  2/60 (3.33%) 
Hiccups  1  1/60 (1.67%) 
Hypoxia  1  1/60 (1.67%) 
Laryngeal edema  1  1/60 (1.67%) 
Nasal congestion  1  1/60 (1.67%) 
Pleural effusion  1  1/60 (1.67%) 
Postnasal drip  1  2/60 (3.33%) 
Pulmonary edema  1  2/60 (3.33%) 
Sore throat  1  1/60 (1.67%) 
Respiratory, thoracic and mediastinal disorders - Other, specify  1  1/60 (1.67%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  1/60 (1.67%) 
Dry skin  1  2/60 (3.33%) 
Hyperhidrosis  1  2/60 (3.33%) 
Nail ridging  1  1/60 (1.67%) 
Palmar-plantar erythrodysesthesia syndrome  1  1/60 (1.67%) 
Rash acneiform  1  1/60 (1.67%) 
Rash maculo-papular  1  8/60 (13.33%) 
Skin hyperpigmentation  1  1/60 (1.67%) 
Skin ulceration  1  1/60 (1.67%) 
Skin and subcutaneous tissue disorders - Other, specify  1  4/60 (6.67%) 
Surgical and medical procedures   
Surgical and medical procedures - Other, specify  1  2/60 (3.33%) 
Vascular disorders   
Flushing  1  5/60 (8.33%) 
Hot flashes  1  1/60 (1.67%) 
Hypertension  1  6/60 (10.00%) 
Hypotension  1  5/60 (8.33%) 
Thromboembolic event  1  1/60 (1.67%) 
Vascular disorders - Other, specify  1  1/60 (1.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
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/Title: Matthew H. Kulke, MD
Organization: Dana-Farber Cancer Institute
Phone: 617.632.5136
Responsible Party: Matthew H. Kulke, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01024387     History of Changes
Other Study ID Numbers: 09-240
First Submitted: December 1, 2009
First Posted: December 2, 2009
Results First Submitted: November 30, 2017
Results First Posted: December 27, 2017
Last Update Posted: March 8, 2018