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Trial record 99 of 851 for:    Pancreatic Cancer AND Metastatic Pancreatic Cancer

Phase II Trial Of Gemcitabine Plus Nab-Paclitaxel +/- OGX-427 In Patients With Metastatic Pancreatic Cancer (Rainier)

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: NCT01844817
Recruitment Status : Completed
First Posted : May 1, 2013
Results First Posted : May 16, 2017
Last Update Posted : May 16, 2017
Sponsor:
Collaborator:
Achieve Life Sciences
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Interventions Drug: OGX-427
Drug: Placebo
Enrollment 132
Recruitment Details Between September 2013 and December 2014, 132 subjhects with untreated metastatic pancreatic cancer were enrolled in the trial from 11 U.S. investigational sites.
Pre-assignment Details Subjects were enrolled and randomized in a 1:1 ratio (66 per Arm) to receive a combination of gemcitabine and nab-paclitaxel plus either OGX-427 (apatorsen) or a placebo.
Arm/Group Title OGX-427 Placebo
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OGX-427: Three separate loading doses at 600mg IV over 1 week prior to Cycle 1 of chemotherapy, followed by 600mg IV once weekly on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.

Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment.

Placebo (dextrose 5% in water): Three separate loading doses administered over 1 week prior to Cycle 1 of chemotherapy, followed by weekly doses on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.

Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment.

Period Title: Enrolled and Randomized
Started 66 66
Completed [1] 64 63
Not Completed 2 3
Reason Not Completed
Withdrawal by Subject             2             3
[1]
5 patients withdrew prior to treatment.
Period Title: Treatment
Started 64 63
Completed 0 0
Not Completed 64 63
Reason Not Completed
Progressive Disease             27             36
Adverse Event             17             9
Withdrawal by Subject             10             6
Death             10             8
Lost to Follow-up             0             1
Other             0             3
Arm/Group Title OGX-427 Placebo Total
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OGX-427: Three separate loading doses at 600mg IV over 1 week prior to Cycle 1 of chemotherapy, followed by 600mg IV once weekly on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.

Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment.

Placebo (Dextrose 5% in Water): Three separate loading doses administered over 1 week prior to Cycle 1 of chemotherapy, followed by weekly doses on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.

Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment.

Total of all reporting groups
Overall Number of Baseline Participants 66 66 132
Hide Baseline Analysis Population Description
Intent-to-Treat Population: All patients who met eligibility requirements and gave written informed consent.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 66 participants 66 participants 132 participants
66.5
(39 to 82)
65.5
(47 to 83)
66
(39 to 83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 66 participants 132 participants
Female
29
  43.9%
28
  42.4%
57
  43.2%
Male
37
  56.1%
38
  57.6%
75
  56.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 66 participants 132 participants
White
56
  84.8%
61
  92.4%
117
  88.6%
Black/African American
10
  15.2%
5
   7.6%
15
  11.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 66 participants 66 participants 132 participants
66 66 132
1.Primary Outcome
Title Overall Survival
Hide Description Overall survival defined as the time, in months, from date of randomization until date of death or date last known alive whichever comes first, assessed up to 2 years.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Includes Intent-to-Treat Population: all subjects enrolled and randomized
Arm/Group Title OGX-427 Placebo
Hide Arm/Group Description:

OGX-427: Three separate loading doses at 600mg IV over 1 week prior to Cycle 1 of chemotherapy, followed by 600mg IV once weekly on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.

Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment.

Placebo (Dextrose 5% in Water): Three separate loading doses administered over 1 week prior to Cycle 1 of chemotherapy, followed by weekly doses on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.

Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment.

Overall Number of Participants Analyzed 66 66
Median (95% Confidence Interval)
Unit of Measure: months
5.3
(3.2 to 7.0)
6.9
(5.8 to 9.3)
2.Secondary Outcome
Title Progression-Free Survival
Hide Description The time (in months) that patients are progression-free, assessed from date of randomization to date of first documented disease progression or date of death from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest (nadir) sum while on study (this includes the baseline sum if that is the smallest on study), or the appearance of one or more new lesions.
Time Frame Every 8 weeks up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population: all subjects enrolled and randomized
Arm/Group Title OGX-427 Placebo
Hide Arm/Group Description:

OGX-427: Three separate loading doses at 600mg IV over 1 week prior to Cycle 1 of chemotherapy, followed by 600mg IV once weekly on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.

Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment.

Placebo (Dextrose 5% in Water): Three separate loading doses administered over 1 week prior to Cycle 1 of chemotherapy, followed by weekly doses on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.

Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment.

Overall Number of Participants Analyzed 66 66
Median (95% Confidence Interval)
Unit of Measure: months
2.7
(2.2 to 3.7)
3.8
(2.3 to 4.7)
3.Secondary Outcome
Title Objective Response Rate
Hide Description Objective response rate defined as the percent of patients having a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR=complete disappearance of all target lesions. PR=decrease in baseline of 30% or more of the diameter(s) of all target lesions.
Time Frame Every 8 weeks for up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Includes Intent-to-Treat Population: all subjects enrolled and randomized
Arm/Group Title OGX-427 Placebo
Hide Arm/Group Description:

OGX-427: Three separate loading doses at 600mg IV over 1 week prior to Cycle 1 of chemotherapy, followed by 600mg IV once weekly on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.

Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment.

Placebo (Dextrose 5% in water): Three separate loading doses administered over 1 week prior to Cycle 1 of chemotherapy, followed by weekly doses on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.

Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment.

Overall Number of Participants Analyzed 66 66
Measure Type: Number
Unit of Measure: percentage of participants
PR 18 18
CR 0 0
Time Frame weekly for approximately 24 months
Adverse Event Reporting Description All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
 
Arm/Group Title OGX-427 Placebo
Hide Arm/Group Description

OGX-427: Three separate loading doses at 600mg IV over 1 week prior to Cycle 1 of chemotherapy, followed by 600mg IV once weekly on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.

Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment.

Placebo (dextrose 5% in water): Three separate loading doses administered over 1 week prior to Cycle 1 of chemotherapy, followed by weekly doses on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.

Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment.

All-Cause Mortality
OGX-427 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
OGX-427 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   64/64 (100.00%)   63/63 (100.00%) 
Blood and lymphatic system disorders     
Anaemia * 1  9/64 (14.06%)  6/63 (9.52%) 
Haemolytic Uraemic Syndrome * 1  3/64 (4.69%)  3/63 (4.76%) 
Febrile Neutropeniua * 1  0/64 (0.00%)  3/63 (4.76%) 
Hypotension * 1  0/64 (0.00%)  3/63 (4.76%) 
Neutropenia * 1  3/64 (4.69%)  0/63 (0.00%) 
Cardiac disorders     
Atrial Fibrillation * 1  9/64 (14.06%)  6/63 (9.52%) 
Acute Myocardial Infarction * 1  3/64 (4.69%)  3/63 (4.76%) 
Cardiac Failure Congestive * 1  0/64 (0.00%)  6/63 (9.52%) 
Cardiac Arrest * 1  0/64 (0.00%)  3/63 (4.76%) 
Gastrointestinal disorders     
Abdominal Pain * 1  12/64 (18.75%)  9/63 (14.29%) 
Diarrhoea * 1  6/64 (9.38%)  6/63 (9.52%) 
Gastrointestinal Haemorrhage * 1  9/64 (14.06%)  3/63 (4.76%) 
Obstruction Gastric * 1  0/64 (0.00%)  9/63 (14.29%) 
Vomiting * 1  3/64 (4.69%)  6/63 (9.52%) 
Nausea * 1  3/64 (4.69%)  3/63 (4.76%) 
Abdominal Pain Upper * 1  3/64 (4.69%)  0/63 (0.00%) 
Ascites * 1  0/64 (0.00%)  3/63 (4.76%) 
Constipation * 1  3/64 (4.69%)  0/63 (0.00%) 
Duodenal Obstruction * 1  3/64 (4.69%)  0/63 (0.00%) 
Duodenal Stenosis * 1  3/64 (4.69%)  0/63 (0.00%) 
Gastric Varices Haemorrhage * 1  0/64 (0.00%)  3/63 (4.76%) 
Gastritis * 1  3/64 (4.69%)  0/63 (0.00%) 
Gastritis Erosive * 1  3/64 (4.69%)  0/63 (0.00%) 
Haemorrhagic Ascites * 1  0/64 (0.00%)  3/63 (4.76%) 
Ileus Spastic * 1  0/64 (0.00%)  3/63 (4.76%) 
Intestinal Obstruction * 1  3/64 (4.69%)  0/63 (0.00%) 
Intestinal Perforation * 1  0/64 (0.00%)  3/63 (4.76%) 
Large Intestine Perforation * 1  3/64 (4.69%)  0/63 (0.00%) 
Pancreatitis Acute * 1  0/64 (0.00%)  3/63 (4.76%) 
Peptic Ulcer * 1  3/64 (4.69%)  0/63 (0.00%) 
General disorders     
Pyrexia * 1  12/64 (18.75%)  0/63 (0.00%) 
Device Occlusion * 1  0/64 (0.00%)  6/63 (9.52%) 
Fatigue * 1  6/64 (9.38%)  0/63 (0.00%) 
Asthenia * 1  0/64 (0.00%)  3/63 (4.76%) 
Chest Pain * 1  3/64 (4.69%)  0/63 (0.00%) 
Device Related Infection * 1  0/64 (0.00%)  3/63 (4.76%) 
Lethargy * 1  3/64 (4.69%)  0/63 (0.00%) 
Mucosal Inflammation * 1  3/64 (4.69%)  0/63 (0.00%) 
Hepatobiliary disorders     
Bile Duct Obstruction * 1  9/64 (14.06%)  3/63 (4.76%) 
Small Intestine Obstruction * 1  3/64 (4.69%)  3/63 (4.76%) 
Biliary Tract Infection * 1  0/64 (0.00%)  3/63 (4.76%) 
Haematochezia * 1  0/64 (0.00%)  3/63 (4.76%) 
Immune system disorders     
Anaphylactic Reaction * 1  3/64 (4.69%)  0/63 (0.00%) 
Infections and infestations     
Sepsis * 1  18/64 (28.13%)  9/63 (14.29%) 
Pneumonia * 1  12/64 (18.75%)  6/63 (9.52%) 
Cellulitis * 1  3/64 (4.69%)  6/63 (9.52%) 
Bursitis Infective Staphylococcal * 1  0/64 (0.00%)  3/63 (4.76%) 
Cholangitis Infective * 1  3/64 (4.69%)  0/63 (0.00%) 
Klebsiella Infection * 1  3/64 (4.69%)  0/63 (0.00%) 
Urinary Tract Infection * 1  0/64 (0.00%)  3/63 (4.76%) 
Investigations     
Failure to Thrive * 1  0/64 (0.00%)  3/63 (4.76%) 
Metabolism and nutrition disorders     
Dehydration * 1  18/64 (28.13%)  12/63 (19.05%) 
Hyponatraemia * 1  3/64 (4.69%)  3/63 (4.76%) 
Decreased Appetite * 1  0/64 (0.00%)  3/63 (4.76%) 
Electrolyte Imbalance * 1  0/64 (0.00%)  3/63 (4.76%) 
Nervous system disorders     
Oedema Peripheral * 1  3/64 (4.69%)  0/63 (0.00%) 
Systemic Inflammatory Response * 1  3/64 (4.69%)  0/63 (0.00%) 
Renal and urinary disorders     
Acute Kidney Injury * 1  12/64 (18.75%)  3/63 (4.76%) 
Renal Failure * 1  3/64 (4.69%)  3/63 (4.76%) 
Urosepsis * 1  3/64 (4.69%)  0/63 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary Embolism * 1  9/64 (14.06%)  3/63 (4.76%) 
Respiratory Failure * 1  3/64 (4.69%)  3/63 (4.76%) 
Skin and subcutaneous tissue disorders     
Bacteraemia * 1  0/64 (0.00%)  3/63 (4.76%) 
Vascular disorders     
Deep Vein Thrombosis * 1  3/64 (4.69%)  9/63 (14.29%) 
Cerebrovascular Accident * 1  6/64 (9.38%)  0/63 (0.00%) 
Ischaemic Stroke * 1  3/64 (4.69%)  0/63 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 19.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
OGX-427 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   62/64 (96.88%)   62/63 (98.41%) 
Blood and lymphatic system disorders     
Anaemia * 1  36/64 (56.25%)  40/63 (63.49%) 
Thrombocytopenia * 1  27/64 (42.19%)  21/63 (33.33%) 
Neutropenia * 1  18/64 (28.13%)  21/63 (33.33%) 
Leukopenia * 1  8/64 (12.50%)  6/63 (9.52%) 
Cardiac disorders     
Tachycardia * 1  5/64 (7.81%)  5/63 (7.94%) 
Gastrointestinal disorders     
Nausea * 1  34/64 (53.13%)  40/63 (63.49%) 
Abdominal Pain * 1  26/64 (40.63%)  21/63 (33.33%) 
Diarrhoea * 1  28/64 (43.75%)  18/63 (28.57%) 
Vomiting * 1  26/64 (40.63%)  20/63 (31.75%) 
Constipation * 1  20/64 (31.25%)  22/63 (34.92%) 
Dyspepsia * 1  7/64 (10.94%)  5/63 (7.94%) 
Ascites * 1  5/64 (7.81%)  5/63 (7.94%) 
Flatulence * 1  4/64 (6.25%)  6/63 (9.52%) 
Abdominal Pain Upper * 1  7/64 (10.94%)  2/63 (3.17%) 
Stomatitis * 1  6/64 (9.38%)  3/63 (4.76%) 
Gastroesophageal Reflux * 1  4/64 (6.25%)  4/63 (6.35%) 
Abdominal Distention * 1  3/64 (4.69%)  4/63 (6.35%) 
General disorders     
Fatigure * 1  41/64 (64.06%)  44/63 (69.84%) 
Oedema Peripheral * 1  26/64 (40.63%)  16/63 (25.40%) 
Pyrexia * 1  21/64 (32.81%)  17/63 (26.98%) 
Asthenia * 1  9/64 (14.06%)  11/63 (17.46%) 
Chills * 1  4/64 (6.25%)  9/63 (14.29%) 
Pain * 1  5/64 (7.81%)  4/63 (6.35%) 
Peripheral Swelling * 1  2/64 (3.13%)  7/63 (11.11%) 
Mucosal Inflammation * 1  4/64 (6.25%)  3/63 (4.76%) 
Infections and infestations     
Urinary Tract Infections * 1  9/64 (14.06%)  4/63 (6.35%) 
Pneumonia * 1  6/64 (9.38%)  3/63 (4.76%) 
Sepsis * 1  5/64 (7.81%)  4/63 (6.35%) 
Upper Respiratory Track Infection * 1  6/64 (9.38%)  2/63 (3.17%) 
Investigations     
Alanine Aminotransferase Increased * 1  16/64 (25.00%)  16/63 (25.40%) 
Aspartate Aminotransferase Increased * 1  16/64 (25.00%)  13/63 (20.63%) 
Platelet Count Decreased * 1  16/64 (25.00%)  11/63 (17.46%) 
Blood Alkaline Phosphatase Increased * 1  11/64 (17.19%)  13/63 (20.63%) 
Weight Decreased * 1  12/64 (18.75%)  12/63 (19.05%) 
Neutrophil Count Decreased * 1  6/64 (9.38%)  9/63 (14.29%) 
Blood Bilirubin Increased * 1  7/64 (10.94%)  7/63 (11.11%) 
Blood Creatinine Increased * 1  8/64 (12.50%)  4/63 (6.35%) 
Metabolism and nutrition disorders     
Decreased Appetite * 1  23/64 (35.94%)  22/63 (34.92%) 
Dehydration * 1  16/64 (25.00%)  18/63 (28.57%) 
Hypokalaemia * 1  10/64 (15.63%)  8/63 (12.70%) 
Hyponatraemia * 1  9/64 (14.06%)  6/63 (9.52%) 
Hyperglycaemia * 1  7/64 (10.94%)  5/63 (7.94%) 
Hyperalbuminaemia * 1  4/64 (6.25%)  7/63 (11.11%) 
Hypocalcaemia * 1  5/64 (7.81%)  3/63 (4.76%) 
Musculoskeletal and connective tissue disorders     
Pain in Extremity * 1  6/64 (9.38%)  7/63 (11.11%) 
Muscular Weakness * 1  5/64 (7.81%)  7/63 (11.11%) 
Myalgia * 1  7/64 (10.94%)  5/63 (7.94%) 
Arthralgia * 1  8/64 (12.50%)  3/63 (4.76%) 
Back Pain * 1  5/64 (7.81%)  3/63 (4.76%) 
Psychiatric disorders     
Insomnia * 1  10/64 (15.63%)  15/63 (23.81%) 
Anxiety * 1  7/64 (10.94%)  8/63 (12.70%) 
Depression * 1  8/64 (12.50%)  2/63 (3.17%) 
Renal and urinary disorders     
Acute Kidney Injury * 1  6/64 (9.38%)  3/63 (4.76%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea * 1  15/64 (23.44%)  12/63 (19.05%) 
Cough * 1  13/64 (20.31%)  6/63 (9.52%) 
Pulmonary Embolism * 1  6/64 (9.38%)  5/63 (7.94%) 
Epistaxis * 1  4/64 (6.25%)  5/63 (7.94%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1  16/64 (25.00%)  15/63 (23.81%) 
Rash * 1  9/64 (14.06%)  16/63 (25.40%) 
Pruritis * 1  4/64 (6.25%)  3/63 (4.76%) 
Vascular disorders     
Hypotension * 1  8/64 (12.50%)  10/63 (15.87%) 
Deep Vein Thrombosis * 1  4/64 (6.25%)  8/63 (12.70%) 
Hypertension * 1  4/64 (6.25%)  7/63 (11.11%) 
Flushing * 1  4/64 (6.25%)  5/63 (7.94%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 19.1
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 sponsor can review/embargo results communications prior to public release for a period that is >60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Charles Davis, RAC
Organization: Sarah Cannon Development Innovations
EMail: Charles.Davis2@scri-innovations.com
Layout table for additonal information
Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT01844817     History of Changes
Other Study ID Numbers: SCRI GI 184
First Submitted: April 29, 2013
First Posted: May 1, 2013
Results First Submitted: February 8, 2017
Results First Posted: May 16, 2017
Last Update Posted: May 16, 2017