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Trial record 26 of 1322 for:    survival | Neuroendocrine Tumors

AMG 706 and Octreotide in Treating Patients With Low-Grade Neuroendocrine Tumors

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ClinicalTrials.gov Identifier: NCT00427349
Recruitment Status : Completed
First Posted : January 29, 2007
Results First Posted : June 4, 2015
Last Update Posted : August 12, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Gastrointestinal Carcinoid Tumor
Islet Cell Tumor
Neoplastic Syndrome
Interventions Drug: AMG 706
Drug: octreotide
Enrollment 46
Recruitment Details This study was activated on September 16, 2008 and closed on March 18, 2010 with 46 patients registered to the study from 10 ECOG-ACRIN affiliated institutions.
Pre-assignment Details  
Arm/Group Title AMG 706+Octreotide
Hide Arm/Group Description

Patients receive oral AMG 706 and octreotide acetate intramuscularly once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

AMG 706: AMG 706 was administered on a flat scale of mg/day and not by weight or body surface area (BSA). AMG 706 was provided as a 25 mg tablet; the daily dose was 125 mg administered as five 25 mg tablets in the AM. AMG 706 was taken daily without breaks in treatment.

octreotide: One dose consisted of octreotide-LAR 30 mg administered IM on day 1 of each cycle. The first octreotide-LAR injection would correspond with the first day of AMG 706 and then on day 1 of subsequent cycles.

Period Title: Overall Study
Started 46
Eligible 45
Treated 45
Eligible and Treated 44
Completed 0 [1]
Not Completed 46
Reason Not Completed
Lack of Efficacy             23
Adverse Event             14
Death             1
Withdrawal by Subject             3
Alternative therapy             1
Other             2
Ineligible             1
Never started therapy             1
[1]
Treatment continued until disease progression or intolerable toxicity
Arm/Group Title AMG 706+Octreotide
Hide Arm/Group Description

Patients receive oral AMG 706 and octreotide acetate intramuscularly once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

AMG 706: AMG 706 was administered on a flat scale of mg/day and not by weight or body surface area (BSA). AMG 706 was provided as a 25 mg tablet; the daily dose was 125 mg administered as five 25 mg tablets in the AM. AMG 706 was taken daily without breaks in treatment.

octreotide: One dose consisted of octreotide-LAR 30 mg administered IM on day 1 of each cycle. The first octreotide-LAR injection would correspond with the first day of AMG 706 and then on day 1 of subsequent cycles.

Overall Number of Baseline Participants 44
Hide Baseline Analysis Population Description
Per protocol, the primary population for all efficacy analysis is all eligible and treated patients
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 44 participants
65
(38 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Female
20
  45.5%
Male
24
  54.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 44 participants
44
1.Primary Outcome
Title Four-month Progression-free Survival Rate
Hide Description Four-month progression-free survival (PFS) rate is defined as number of patients who are still progression free at 4 months after study entry divided by number of eligible and treated patients enrolled to the study. Progression is evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s), or unequivocal progression of existing non-target lesions.
Time Frame assessed every 4 weeks while on treatment and at three months post-treatment for participants treated for one cycle, up to month four
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all 44 eligible and treated patients. But 2 patients did not have disease assessment after study entry and are excluded from the analysis.
Arm/Group Title AMG 706+Octreotide
Hide Arm/Group Description:

Patients receive oral AMG 706 and octreotide acetate intramuscularly once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

AMG 706: AMG 706 was administered on a flat scale of mg/day and not by weight or body surface area (BSA). AMG 706 was provided as a 25 mg tablet; the daily dose was 125 mg administered as five 25 mg tablets in the AM. AMG 706 was taken daily without breaks in treatment.

octreotide: One dose consisted of octreotide-LAR 30 mg administered IM on day 1 of each cycle. The first octreotide-LAR injection would correspond with the first day of AMG 706 and then on day 1 of subsequent cycles.

Overall Number of Participants Analyzed 42
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
78.5
(65.6 to 88.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AMG 706+Octreotide
Comments The null hypothesis is that the 4-month progression free survival rate is 20%. Alternatively, AMG 706 will be considered worthy of further study if its true progression-free survival rate is 40% or better at 4 months (alternative hypothesis).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method one sample binomial test
Comments The study result was compared to a null hypothesis of 20% 4-month progression free survival rate using one sample binomial test
2.Secondary Outcome
Title Overall Survival
Hide Description Overall survival (OS) is defined as the time from registration until death (event), or censored at last date known alive. OS was estimated using the Kaplan-Meier method , with 95% confidence intervals calculated using Greenwood’s formula
Time Frame assessed every 3 months if patient is < 2 years from study entry, then every 6 months up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible and treated patients
Arm/Group Title AMG 706+Octreotide
Hide Arm/Group Description:

Patients receive oral AMG 706 and octreotide acetate intramuscularly once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

AMG 706: AMG 706 was administered on a flat scale of mg/day and not by weight or body surface area (BSA). AMG 706 was provided as a 25 mg tablet; the daily dose was 125 mg administered as five 25 mg tablets in the AM. AMG 706 was taken daily without breaks in treatment.

octreotide: One dose consisted of octreotide-LAR 30 mg administered IM on day 1 of each cycle. The first octreotide-LAR injection would correspond with the first day of AMG 706 and then on day 1 of subsequent cycles.

Overall Number of Participants Analyzed 44
Median (95% Confidence Interval)
Unit of Measure: months
27.5
(14.6 to 45.1)
3.Secondary Outcome
Title Objective Response Rate
Hide Description Tumor response was evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Objective response rate is defined as number of patients with complete response (CR) or partial response (PR) divided by the total number of analyzable patients. CR is defined as complete disappearance of all tumor lesions, and partial response is defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter.
Time Frame assessed every 8 weeks while on treatment, and frequency of tumor measurements during follow-up were determined by the treating physician, assessed up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AMG 706+Octreotide
Hide Arm/Group Description:

Patients receive oral AMG 706 and octreotide acetate intramuscularly once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

AMG 706: AMG 706 was administered on a flat scale of mg/day and not by weight or body surface area (BSA). AMG 706 was provided as a 25 mg tablet; the daily dose was 125 mg administered as five 25 mg tablets in the AM. AMG 706 was taken daily without breaks in treatment.

octreotide: One dose consisted of octreotide-LAR 30 mg administered IM on day 1 of each cycle. The first octreotide-LAR injection would correspond with the first day of AMG 706 and then on day 1 of subsequent cycles.

Overall Number of Participants Analyzed 44
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
13.6
(6 to 25)
Time Frame Assessed at the end of each cycle (1 cycle=28 days) while on treatment and for 30 days after the end of treatment
Adverse Event Reporting Description Late adverse events (defined as any adverse events occur prior to diagnosis of progression/relapse and has not been previously reported) are collected via the long-term follow up forms at each follow-up visit.
 
Arm/Group Title MG 706+Octreotide
Hide Arm/Group Description AMG 706 was administered on a flat scale of mg/day and not by weight or body surface area (BSA). AMG 706 was provided as a 25 mg tablet; the daily dose was 125 mg administered as five 25 mg tablets in the AM. AMG 706 was taken daily without breaks in treatment. Each cycle was defined as 28 days. AMG 706 was started within 7 working days of registration, given on the same day as the octreotide-LAR.
All-Cause Mortality
MG 706+Octreotide
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
MG 706+Octreotide
Affected / at Risk (%)
Total   26/45 (57.78%) 
Blood and lymphatic system disorders   
Anemia  1  2/45 (4.44%) 
Gastrointestinal disorders   
Diarrhea  1  4/45 (8.89%) 
Nausea  1  3/45 (6.67%) 
Vomiting  1  2/45 (4.44%) 
Intra-abdominal hemorrhage  1  1/45 (2.22%) 
Abdominal pain  1  4/45 (8.89%) 
General disorders   
Fatigue  1  6/45 (13.33%) 
Hepatobiliary disorders   
Cholecystitis  1  5/45 (11.11%) 
Infections and infestations   
Urinary tract infection  1  1/45 (2.22%) 
Infections and infestations - blood  1  1/45 (2.22%) 
Investigations   
Lymphocyte count decreased  1  1/45 (2.22%) 
Platelet count decreased  1  3/45 (6.67%) 
Electrocardiogram QT corrected interval  1  1/45 (2.22%) 
Weight loss  1  1/45 (2.22%) 
INR increased  1  1/45 (2.22%) 
Alkaline phosphatase increased  1  2/45 (4.44%) 
Alanine aminotransferase increased  1  1/45 (2.22%) 
Aspartate aminotransferase increased  1  1/45 (2.22%) 
Blood bilirubin increased  1  1/45 (2.22%) 
Lipase increased  1  1/45 (2.22%) 
Metabolism and nutrition disorders   
Anorexia  1  2/45 (4.44%) 
Dehydration  1  2/45 (4.44%) 
Hypocalcemia  1  1/45 (2.22%) 
Hypomagnesemia  1  1/45 (2.22%) 
Hypokalemia  1  1/45 (2.22%) 
Nervous system disorders   
Ataxia  1  2/45 (4.44%) 
Dizziness  1  1/45 (2.22%) 
Headache  1  2/45 (4.44%) 
Psychiatric disorders   
Confusion  1  1/45 (2.22%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary hypertension  1  1/45 (2.22%) 
Dyspnea  1  1/45 (2.22%) 
Vascular disorders   
Hypertension  1  12/45 (26.67%) 
Thromboembolic event  1  1/45 (2.22%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 3.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MG 706+Octreotide
Affected / at Risk (%)
Total   43/45 (95.56%) 
Blood and lymphatic system disorders   
Anemia  1  11/45 (24.44%) 
Cardiac disorders   
Left ventricular systolic dysfunction  1  7/45 (15.56%) 
Gastrointestinal disorders   
Constipation  1  6/45 (13.33%) 
Diarrhea  1  23/45 (51.11%) 
Abdominal distension  1  8/45 (17.78%) 
Dry mouth  1  3/45 (6.67%) 
Flatulence  1  4/45 (8.89%) 
Nausea  1  13/45 (28.89%) 
Vomiting  1  9/45 (20.00%) 
Abdominal pain  1  9/45 (20.00%) 
General disorders   
Fatigue  1  29/45 (64.44%) 
Edema limbs  1  3/45 (6.67%) 
Investigations   
White blood cell decreased  1  11/45 (24.44%) 
Lymphocyte count decreased  1  7/45 (15.56%) 
Neutrophil count decreased  1  7/45 (15.56%) 
Platelet count decreased  1  13/45 (28.89%) 
Weight loss  1  21/45 (46.67%) 
Alkaline phosphatase increased  1  9/45 (20.00%) 
Alanine aminotransferase increased  1  4/45 (8.89%) 
Aspartate aminotransferase increased  1  12/45 (26.67%) 
Blood bilirubin increased  1  3/45 (6.67%) 
Creatinine increased  1  3/45 (6.67%) 
Metabolism and nutrition disorders   
Anorexia  1  15/45 (33.33%) 
Hypoalbuminemia  1  5/45 (11.11%) 
Hyperglycemia  1  11/45 (24.44%) 
Hypokalemia  1  4/45 (8.89%) 
Hyponatremia  1  4/45 (8.89%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  3/45 (6.67%) 
Myalgia  1  6/45 (13.33%) 
Nervous system disorders   
Dizziness  1  5/45 (11.11%) 
Peripheral sensory neuropathy  1  3/45 (6.67%) 
Headache  1  16/45 (35.56%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  5/45 (11.11%) 
Voice alteration  1  4/45 (8.89%) 
Skin and subcutaneous tissue disorders   
Hyperhidrosis  1  3/45 (6.67%) 
Vascular disorders   
Hypertension  1  26/45 (57.78%) 
Hypotension  1  3/45 (6.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 3.0
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
Layout table for Results Point of Contact information
Name/Title: Study Statistician
Organization: ECOG-ACRIN Statistical Office
Phone: 617-632-3012
Layout table for additonal information
Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00427349     History of Changes
Other Study ID Numbers: CDR0000526256
ECOG-E4206 ( Other Identifier: Eastern Cooperative Oncology Group (ECOG) )
U10CA023318 ( U.S. NIH Grant/Contract )
First Submitted: January 25, 2007
First Posted: January 29, 2007
Results First Submitted: May 19, 2015
Results First Posted: June 4, 2015
Last Update Posted: August 12, 2016