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A Randomized Study of Amplimexon (Imexon) With Gemcitabine in Pancreatic Cancer

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: NCT00637247
Recruitment Status : Completed
First Posted : March 17, 2008
Results First Posted : November 30, 2010
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
AmpliMed Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pancreatic Neoplasms
Interventions Drug: imexon in combination with gemcitabine
Drug: imexon placebo + gemcitabine
Enrollment 142
Recruitment Details Recruitment period was from April 2008 to May 2009. Enrollment occurred at 34 clinical centers in the United States.
Pre-assignment Details  
Arm/Group Title Amplimexon (Imexon) + Gemcitabine Imexon Placebo + Gemcitabine
Hide Arm/Group Description Amplimexon 875 mg/m^2 + gemcitabine 1000 mg/m^2 Placebo 875 mg/m^2+ gemcitabine 1000 mg/m^2
Period Title: Overall Study
Started 72 70
Completed 72 70
Not Completed 0 0
Arm/Group Title Amplimexon (Imexon) + Gemcitabine Imexon Placebo + Gemcitabine Total
Hide Arm/Group Description Amplimexon 875 mg/m^2 + gemcitabine 1000 mg/m^2 Placebo 875 mg/m^2+ gemcitabine 1000 mg/m^2 Total of all reporting groups
Overall Number of Baseline Participants 72 70 142
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 70 participants 142 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
34
  47.2%
31
  44.3%
65
  45.8%
>=65 years
38
  52.8%
39
  55.7%
77
  54.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 72 participants 70 participants 142 participants
66.1  (10.6) 64.9  (11.1) 65.5  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 70 participants 142 participants
Female
31
  43.1%
31
  44.3%
62
  43.7%
Male
41
  56.9%
39
  55.7%
80
  56.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 72 participants 70 participants 142 participants
72 70 142
1.Primary Outcome
Title Overall Survival for the Intent to Treat Population
Hide Description To compare the overall survival duration of the two treatment arms. Overall survival is measured from the time of randomization until reported death. Subjects were censored at last time known alive if lost to follow-up. Alive patients were censored at the last survival follow-up. Follow-up was monthly after off study treatment.
Time Frame up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat with subjects who were alive at the time of the survival analysis or lost to follow-up were considered censored at the last date the subject was known to be alive.
Arm/Group Title Amplimexon (Imexon) + Gemcitabine Imexon Placebo + Gemcitabine
Hide Arm/Group Description:
Amplimexon 875 mg/m^2 + gemcitabine 1000 mg/m^2
Placebo 875 mg/m^2+ gemcitabine 1000 mg/m^2
Overall Number of Participants Analyzed 72 70
Median (95% Confidence Interval)
Unit of Measure: months
5.2
(4.2 to 6.7)
6.8
(4.9 to 8.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Amplimexon (Imexon) + Gemcitabine, Imexon Placebo + Gemcitabine
Comments The hypothesis that survival curves were equal in the two treatment groups was tested with a one-sided logrank test at the alpha-0.2 level, one sided. The power of this test is 80% for detecting the hypothesized increase in median survival of 2.4 months for subjects in the experimental arm.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
2.Primary Outcome
Title To Evaluate and Compare the Tolerability and Toxicity of the Two Treatment Arms by Comparing Adverse Events
Hide Description Number of Participants with Adverse Events were compared between the two arms to detect any differences in number or types of events
Time Frame Adverse events were collected from the time of treatment until the participant went off study treatment, an average of 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
This includes only those subjects that received at least 1 dose of study treatment. There were 67 subjects in the imexon + gemcitabine arm and 68 in the placebo + gemcitabine arm.
Arm/Group Title Imexon + Gemcitabine Placebo + Gemcitabine
Hide Arm/Group Description:

imexon + gemcitabine

imexon in combination with gemcitabine: 875 mg/m^2 imexon IV + 1000 mg/m^2 gemcitabine IV

Placebo in combination with gemcitabine

imexon placebo + gemcitabine: imexon placebo IV + 1000 mg/m^2 gemcitabine IV

Overall Number of Participants Analyzed 67 68
Measure Type: Number
Unit of Measure: participants
67 68
3.Secondary Outcome
Title Objective Response Rates of the Two Treatment Arms
Hide Description Objective response is measured by tumor reduction as defined in the RECIST criteria. Tumor shrinkage must be at least 30% to qualify as an objective response.
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, response evaluable population was treated and had baseline and at least one response evaluation.
Arm/Group Title Amplimexon (Imexon) + Gemcitabine Imexon Placebo + Gemcitabine
Hide Arm/Group Description:
Amplimexon 875 mg/m^2 + gemcitabine 1000 mg/m^2
Placebo 875 mg/m^2+ gemcitabine 1000 mg/m^2
Overall Number of Participants Analyzed 53 55
Measure Type: Number
Unit of Measure: percent of responses
13.2 16.4
4.Secondary Outcome
Title Progression Free Survival
Hide Description To compare the median progression free survival (PFS) of the two treatment arms. Progression free survival is measured from randomization until the subject has documented disease progression by an objective measure. Subjects were censored if no documented progression had occurred at the one year time point. Subjects must be alive with no more than 20% increase in tumor size to qualify for progression free survival. Changes in tumor size are defined by RECIST criteria.
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title Amplimexon (Imexon) + Gemcitabine Imexon Placebo + Gemcitabine
Hide Arm/Group Description:
Amplimexon 875 mg/m^2 + gemcitabine 1000 mg/m^2
Placebo 875 mg/m^2+ gemcitabine 1000 mg/m^2
Overall Number of Participants Analyzed 72 70
Median (95% Confidence Interval)
Unit of Measure: months
2.8
(2.0 to 4.1)
3.8
(2.2 to 4.7)
Time Frame Adverse events were collected from the time of treatment until the participant went off study treatment. This was an average timeframe of 4 months.
Adverse Event Reporting Description Adverse event reporting was performed on the safety population. This included only those subjects that received at least one dose of drug. This was 67 subjects in the active arm and 68 in the placebo arm.
 
Arm/Group Title Amplimexon (Imexon) + Gemcitabine Imexon Placebo + Gemcitabine
Hide Arm/Group Description Amplimexon 875 mg/m^2 + gemcitabine 1000 mg/m^2 Placebo 875 mg/m^2+ gemcitabine 1000 mg/m^2
All-Cause Mortality
Amplimexon (Imexon) + Gemcitabine Imexon Placebo + Gemcitabine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Amplimexon (Imexon) + Gemcitabine Imexon Placebo + Gemcitabine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   51/67 (76.12%)      44/68 (64.71%)    
Blood and lymphatic system disorders     
Hemoglobin (low)  1  2/67 (2.99%)  2 1/68 (1.47%)  1
Neutrophils (low)  1  0/67 (0.00%)  0 1/68 (1.47%)  1
Fever-neutropenic  1  1/67 (1.49%)  1 0/68 (0.00%)  0
Cardiac disorders     
Conduction abnormality-AV block-third degree  1  1/67 (1.49%)  1 0/68 (0.00%)  0
Supraventricular arrhythmia-atrial fibrillation  1  1/67 (1.49%)  1 0/68 (0.00%)  0
Supraventricular arrhythmia-atrial flutter  1  1/67 (1.49%)  1 0/68 (0.00%)  0
Cardiac ischemia/infarction  1  1/67 (1.49%)  1 0/68 (0.00%)  0
Left ventricular diastolic dysfunction  1  0/67 (0.00%)  0 2/68 (2.94%)  2
Left ventricular systolic dysfunction  1  1/67 (1.49%)  1 0/68 (0.00%)  0
Gastrointestinal disorders     
Ascites  1  0/67 (0.00%)  0 1/68 (1.47%)  1
Constipation  1  2/67 (2.99%)  2 0/68 (0.00%)  0
Distension  1  1/67 (1.49%)  1 0/68 (0.00%)  0
Diarrhea  1  2/67 (2.99%)  2 1/68 (1.47%)  1
Gastrointestinal (GI) other-gastrostromy (G) tube leak  1  1/67 (1.49%)  1 0/68 (0.00%)  0
Nausea  1  1/67 (1.49%)  1 0/68 (0.00%)  0
Obstruction-small bowel not otherwise specified  1  0/67 (0.00%)  0 1/68 (1.47%)  1
Vomiting  1  2/67 (2.99%)  3 2/68 (2.94%)  2
Hemorrhage-abdomen not otherwise specified  1  0/67 (0.00%)  0 1/68 (1.47%)  1
Hemorrhage-duodenum  1  1/67 (1.49%)  1 0/68 (0.00%)  0
Hemorrhage- lower gastrointestinal not otherwise specified  1  0/67 (0.00%)  0 1/68 (1.47%)  1
Hemorrhage-other gastrointestinal  1  0/67 (0.00%)  0 1/68 (1.47%)  1
Hemorrhage-upper gastrointestinal not otherwise specified  1  0/67 (0.00%)  0 1/68 (1.47%)  1
Pancreatitis  1  0/67 (0.00%)  0 3/68 (4.41%)  3
Pain-abdomen not otherwise specified  1  4/67 (5.97%)  4 4/68 (5.88%)  4
Pain-stomach  1  0/67 (0.00%)  0 1/68 (1.47%)  1
General disorders     
Fatigue  1  1/67 (1.49%)  1 0/68 (0.00%)  0
Fever  1  7/67 (10.45%)  7 1/68 (1.47%)  1
Death-death not otherwise specified  1  0/67 (0.00%)  0 4/68 (5.88%)  4
Death-disease progression not otherwise specified  1  15/67 (22.39%)  15 11/68 (16.18%)  11
Edema:trunk/genital  1  0/67 (0.00%)  0 1/68 (1.47%)  1
Pain-chest/thorax not otherwise specified  1  0/67 (0.00%)  0 2/68 (2.94%)  2
Pain-pain not otherwise specified  1  2/67 (2.99%)  2 0/68 (0.00%)  0
Hepatobiliary disorders     
Stricture-biliary tree  1  0/67 (0.00%)  0 2/68 (2.94%)  2
Hepatobiliary-other-biliary obstruction  1  1/67 (1.49%)  1 0/68 (0.00%)  0
Liver dysfunction  1  1/67 (1.49%)  1 2/68 (2.94%)  2
Immune system disorders     
Allergic reaction  1  1/67 (1.49%)  1 0/68 (0.00%)  0
Infections and infestations     
Infection with normal absolute neutrophil count-biliary tree  1  2/67 (2.99%)  3 1/68 (1.47%)  1
Infection with normal absolute neutrophil count-blood  1  1/67 (1.49%)  1 0/68 (0.00%)  0
Infection with normal absolute neutrophil count-lung (pneumonia)  1  5/67 (7.46%)  5 4/68 (5.88%)  5
Infection with normal absolute neutrophil count-cellulitis  1  0/67 (0.00%)  0 2/68 (2.94%)  2
Infection with unknown absolute neutrophil count-lung (pneumonia)  1  1/67 (1.49%)  1 0/68 (0.00%)  0
Injury, poisoning and procedural complications     
Fracture  1  1/67 (1.49%)  1 0/68 (0.00%)  0
Metabolism and nutrition disorders     
Anorexia  1  0/67 (0.00%)  0 1/68 (1.47%)  1
Dehydration  1  3/67 (4.48%)  3 1/68 (1.47%)  1
Hypoglycemia  1  1/67 (1.49%)  1 0/68 (0.00%)  0
Hypokalemia  1  0/67 (0.00%)  0 1/68 (1.47%)  1
Musculoskeletal and connective tissue disorders     
Muscle weakness-whole body/generalized  1  2/67 (2.99%)  2 0/68 (0.00%)  0
Pain-back  1  1/67 (1.49%)  1 0/68 (0.00%)  0
Nervous system disorders     
Central nervous system ischemia  1  0/67 (0.00%)  0 2/68 (2.94%)  2
Syncope (fainting)  1  2/67 (2.99%)  2 0/68 (0.00%)  0
Psychiatric disorders     
Confusion  1  1/67 (1.49%)  1 0/68 (0.00%)  0
Renal and urinary disorders     
Renal failure  1  0/67 (0.00%)  0 4/68 (5.88%)  4
Renal-other-hemolytic uremic syndrome  1  1/67 (1.49%)  1 0/68 (0.00%)  0
Urinary retention  1  0/67 (0.00%)  0 1/68 (1.47%)  1
Respiratory, thoracic and mediastinal disorders     
Hemorrhage-nose  1  0/67 (0.00%)  0 1/68 (1.47%)  1
Aspiration  1  1/67 (1.49%)  1 0/68 (0.00%)  0
Dyspnea  1  2/67 (2.99%)  2 2/68 (2.94%)  2
Hypoxia  1  1/67 (1.49%)  1 1/68 (1.47%)  1
Pleural effusion  1  0/67 (0.00%)  0 1/68 (1.47%)  1
Pneumonitis  1  1/67 (1.49%)  1 0/68 (0.00%)  0
Vascular disorders     
Hypertension  1  1/67 (1.49%)  1 0/68 (0.00%)  0
Peripheral arterial ischemia  1  0/67 (0.00%)  0 1/68 (1.47%)  1
Thrombosis/thrombus/embolism  1  5/67 (7.46%)  5 5/68 (7.35%)  5
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 1%
Amplimexon (Imexon) + Gemcitabine Imexon Placebo + Gemcitabine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   66/67 (98.51%)      68/68 (100.00%)    
Blood and lymphatic system disorders     
Hemoglobin (low)  1  34/67 (50.75%)  84 36/68 (52.94%)  89
Gastrointestinal disorders     
Pain-abdomen not otherwise specified  1  33/67 (49.25%)  50 33/68 (48.53%)  61
Nausea  1  42/67 (62.69%)  64 29/68 (42.65%)  44
Constipation  1  31/67 (46.27%)  41 26/68 (38.24%)  30
Vomiting  1  25/67 (37.31%)  34 24/68 (35.29%)  37
Diarrhea  1  21/67 (31.34%)  23 22/68 (32.35%)  36
General disorders     
Fatigue  1  44/67 (65.67%)  75 44/68 (64.71%)  84
Fever  1  27/67 (40.30%)  49 18/68 (26.47%)  24
Edema:limb  1  23/67 (34.33%)  31 27/68 (39.71%)  38
Rigors/chills  1  16/67 (23.88%)  17 10/68 (14.71%)  12
Investigations     
Platelets (low)  1  28/67 (41.79%)  100 32/68 (47.06%)  102
Neutrophils (low)  1  18/67 (26.87%)  55 32/68 (47.06%)  109
Leukocytes (low)  1  23/67 (34.33%)  84 17/68 (25.00%)  51
ALT (high)  1  18/67 (26.87%)  49 16/68 (23.53%)  36
AST (high)  1  18/67 (26.87%)  38 14/68 (20.59%)  34
Lymphopenia  1  10/67 (14.93%)  35 11/68 (16.18%)  27
Alkaline phosphatase (high)  1  13/67 (19.40%)  21 19/68 (27.94%)  31
Metabolism and nutrition disorders     
Anorexia  1  23/67 (34.33%)  29 26/68 (38.24%)  30
Hyperglycemia  1  10/67 (14.93%)  18 13/68 (19.12%)  31
Hypoalbuminemia  1  4/67 (5.97%)  13 14/68 (20.59%)  26
Hypokalemia  1  13/67 (19.40%)  18 11/68 (16.18%)  13
Musculoskeletal and connective tissue disorders     
Pain-extremity-limb  1  7/67 (10.45%)  12 11/68 (16.18%)  19
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  22/67 (32.84%)  28 20/68 (29.41%)  29
Skin and subcutaneous tissue disorders     
Rash  1  12/67 (17.91%)  18 10/68 (14.71%)  13
Vascular disorders     
Thrombosis/thrombus/embolism  1  12/67 (17.91%)  12 18/68 (26.47%)  19
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.
The manuscript or abstract shall be submitted at least (45) days prior to submission for publication to permit Sponsor to request removal of any Confidential Information and to protect its rights to any patentable inventions set forth therein. Upon Sponsor’s reasonable request, the investigator shall redact Sponsor’s Confidential Information from any such proposed publication or shall delay publication for up to 90 days to permit Sponsor to protect its proprietary Information.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Robert Dorr
Organization: AmpliMed Corporation
Phone: 520-626-7892
EMail: bdorr@azcc.arizona.edu
Publications:
S. J. Cohen, M. M. Zalupski, P. Conkling, F. W. Nugent, W. Ma, M. Modiano, R. A. Pascual, F. Lee, L. Wong, E. Hersh, J Clin Oncol 28:15s, 2010 (suppl; abstr 4076)
Layout table for additonal information
Responsible Party: AmpliMed Corporation
ClinicalTrials.gov Identifier: NCT00637247     History of Changes
Other Study ID Numbers: AMP-019
First Submitted: March 10, 2008
First Posted: March 17, 2008
Results First Submitted: September 17, 2010
Results First Posted: November 30, 2010
Last Update Posted: March 20, 2019