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Trial record 91 of 2836 for:    Pancreatic Cancer

Trial of ICM With or Without AZD2281 (Olaparib) in Patients With Advanced 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: NCT01296763
Recruitment Status : Completed
First Posted : February 15, 2011
Results First Posted : March 22, 2016
Last Update Posted : March 22, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Interventions Drug: Irinotecan
Drug: Cisplatin
Drug: Olaparib (for levels 1 and 5)
Drug: Olaparib (for dose level 2)
Drug: Mitomycin-C
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dose Level 1 Dose Level 2 Dose Level 5
Hide Arm/Group Description
  1. Irinotecan 70 mg/m2 IV, Days 1 and 8
  2. Cisplatin 25 mg/m2 IV, Days 1 and 8
  3. Olaparib 100 mg bid oral, Days 1 and 8
  1. Irinotecan 70 mg/m2 IV, Days 1 and 8
  2. Cisplatin 25 mg/m2 IV, Days 1 and 8
  3. Olaparib 100mg bid oral, Day 1-3, Day 8-10
  1. Irinotecan 70 mg/m2 IV, Days 1 and 8
  2. Cisplatin 25 mg/m2 IV, Days 1 and 8
  3. Mitomycin 5 mg/m2 IV, Day 1
  4. Olaparib 100 mg bid oral, Days 1 and 8
Period Title: Overall Study
Started 7 5 6
Completed 7 5 6
Not Completed 0 0 0
Arm/Group Title Dose Level 1 Dose Level 2 Dose Level 5 Total
Hide Arm/Group Description
  1. Irinotecan 70 mg/m2 IV, Days 1 and 8
  2. Cisplatin 25 mg/m2 IV, Days 1 and 8
  3. Olaparib 100 mg bid oral, Days 1 and 8
  1. Irinotecan 70 mg/m2 IV, Days 1 and 8
  2. Cisplatin 25 mg/m2 IV, Days 1 and 8
  3. Olaparib 100mg bid oral, Day 1-3, Day 8-10
  1. Irinotecan 70 mg/m2 IV, Days 1 and 8
  2. Cisplatin 25 mg/m2 IV, Days 1 and 8
  3. Mitomycin 5 mg/m2 IV, Day 1
  4. Olaparib 100 mg bid oral, Days 1 and 8
Total of all reporting groups
Overall Number of Baseline Participants 7 5 6 18
Hide Baseline Analysis Population Description
Subject with advanced pancreatic cancer
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 5 participants 6 participants 18 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
 100.0%
3
  60.0%
5
  83.3%
15
  83.3%
>=65 years
0
   0.0%
2
  40.0%
1
  16.7%
3
  16.7%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 7 participants 5 participants 6 participants 18 participants
59.28
(47.31 to 65.81)
59.08
(33.09 to 72.9)
51.98
(38.73 to 76.48)
56.79
(33.09 to 76.48)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 5 participants 6 participants 18 participants
Female
3
  42.9%
4
  80.0%
2
  33.3%
9
  50.0%
Male
4
  57.1%
1
  20.0%
4
  66.7%
9
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 5 participants 6 participants 18 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
1
  16.7%
1
   5.6%
Not Hispanic or Latino
7
 100.0%
5
 100.0%
5
  83.3%
17
  94.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 5 participants 6 participants 18 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
1
  16.7%
1
   5.6%
White
7
 100.0%
5
 100.0%
5
  83.3%
17
  94.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 5 participants 6 participants 18 participants
7 5 6 18
1.Primary Outcome
Title Number of Participants Who Experienced a Dose Limiting Toxicity to Determine the Maximum Tolerated Dose (MTD)
Hide Description

1.Phase I - Assess the safety and toxicities of IC with Olaparib escalating to ICM with Olaparib in patients with locally advanced and metastatic pancreatic cancer and determine the phase 2 dose. The number of subjects who experienced a dose limiting toxicity was assessed.Dose-limiting toxicity (DLT) is defined as any of the following study drug-related events experienced during Cycle 1:

Thrombocytopenia with platelets <25,000 x106/l > 7 days. Grade 4 neutropenia lasting ≥7 days. Grade 3 or 4 febrile neutropenia. Grade 3 or greater non-haematological toxicities; excluding grade 3 diarrhoea, nausea or vomiting despite adequate treatment and grade 3 fatigue, lethargy and GGT elevation.

Delay of >2 weeks for next scheduled IC/ICM for reasons of toxicity.

Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects who experienced a dose limiting toxicity, as defined in the protocol.
Arm/Group Title Dose Level 1 Dose Level 2 Dose Level 5
Hide Arm/Group Description:
  1. Irinotecan 70 mg/m2 IV, Days 1 and 8
  2. Cisplatin 25 mg/m2 IV, Days 1 and 8
  3. Olaparib 100 mg bid oral, Days 1 and 8
  1. Irinotecan 70 mg/m2 IV, Days 1 and 8
  2. Cisplatin 25 mg/m2 IV, Days 1 and 8
  3. Olaparib 100mg bid oral, Day 1-3, Day 8-10
  1. Irinotecan 70 mg/m2 IV, Days 1 and 8
  2. Cisplatin 25 mg/m2 IV, Days 1 and 8
  3. Mitomycin 5 mg/m2 IV, Day 1
  4. Olaparib 100 mg bid oral, Days 1 and 8
Overall Number of Participants Analyzed 7 5 6
Measure Type: Number
Unit of Measure: participants
0 2 2
2.Secondary Outcome
Title Number of Years From Cycle 1, Day 1 On-Study to Date of Death
Hide Description The overall survival of subjects with locally advanced and/or metastatic pancreatic cancer treated with Irinotecan, Cisplatin, Olaparib, with escalation to the addition of Mitomycin-C. Survival from cycle 1, day 1 on-study to date of death was assessed.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dose Level 1 Dose Level 2 Dose Level 5
Hide Arm/Group Description:
  1. Irinotecan 70 mg/m2 IV, Days 1 and 8
  2. Cisplatin 25 mg/m2 IV, Days 1 and 8
  3. Olaparib 100 mg bid oral, Days 1 and 8
  1. Irinotecan 70 mg/m2 IV, Days 1 and 8
  2. Cisplatin 25 mg/m2 IV, Days 1 and 8
  3. Olaparib 100mg bid oral, Day 1-3, Day 8-10
  1. Irinotecan 70 mg/m2 IV, Days 1 and 8
  2. Cisplatin 25 mg/m2 IV, Days 1 and 8
  3. Mitomycin 5 mg/m2 IV, Day 1
  4. Olaparib 100 mg bid oral, Days 1 and 8
Overall Number of Participants Analyzed 7 5 6
Mean (Full Range)
Unit of Measure: years (survival) from C1D1 to death
1.43
(0.06 to 4.46)
0.44
(0.08 to 1.03)
0.60
(0.13 to 1.58)
Time Frame up to 30 days after end of study visit.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dose Level 1 Dose Level 2 Dose Level 5
Hide Arm/Group Description
  1. Irinotecan 70 mg/m2 IV, Days 1 and 8
  2. Cisplatin 25 mg/m2 IV, Days 1 and 8
  3. Olaparib 100 mg bid oral, Days 1 and 8
  1. Irinotecan 70 mg/m2 IV, Days 1 and 8
  2. Cisplatin 25 mg/m2 IV, Days 1 and 8
  3. Olaparib 100mg bid oral, Day 1-3, Day 8-10
  1. Irinotecan 70 mg/m2 IV, Days 1 and 8
  2. Cisplatin 25 mg/m2 IV, Days 1 and 8
  3. Mitomycin 5 mg/m2 IV, Day 1
  4. Olaparib 100 mg bid oral, Days 1 and 8
All-Cause Mortality
Dose Level 1 Dose Level 2 Dose Level 5
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dose Level 1 Dose Level 2 Dose Level 5
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/7 (71.43%)      4/5 (80.00%)      4/6 (66.67%)    
Blood and lymphatic system disorders       
Myelodysplastic syndrome  2/7 (28.57%)  2 0/5 (0.00%)  0 0/6 (0.00%)  0
Febrile Neutropenia  2/7 (28.57%)  2 1/5 (20.00%)  1 1/6 (16.67%)  1
Epistaxis  0/7 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1
anemia  0/7 (0.00%)  0 1/5 (20.00%)  1 0/6 (0.00%)  0
Cardiac disorders       
atrial fibrilation  0/7 (0.00%)  0 1/5 (20.00%)  1 0/6 (0.00%)  0
right fronto-temporal subdural hematoma  0/7 (0.00%)  0 1/5 (20.00%)  1 0/6 (0.00%)  0
Gastrointestinal disorders       
Hematemesis  0/7 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1
hemorrhagic gastritis  1/7 (14.29%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0
colonic obstruction  1/7 (14.29%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0
prolapsed colostomy  0/7 (0.00%)  0 1/5 (20.00%)  1 0/6 (0.00%)  0
abdominal pain  0/7 (0.00%)  0 1/5 (20.00%)  1 0/6 (0.00%)  0
ileus  0/7 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dose Level 1 Dose Level 2 Dose Level 5
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/7 (100.00%)      5/5 (100.00%)      6/6 (100.00%)    
Blood and lymphatic system disorders       
anemia  7/7 (100.00%)  3/5 (60.00%)  5/6 (83.33%) 
Cardiac disorders       
atrial fibrillation  0/7 (0.00%)  1/5 (20.00%)  0/6 (0.00%) 
atrial tachycardia  0/7 (0.00%)  1/5 (20.00%)  0/6 (0.00%) 
heart palpitations  1/7 (14.29%)  0/5 (0.00%)  0/6 (0.00%) 
Ear and labyrinth disorders       
clogged ear  0/7 (0.00%)  0/5 (0.00%)  1/6 (16.67%) 
otitis media  0/7 (0.00%)  1/5 (20.00%)  0/6 (0.00%) 
Eye disorders       
blurry vision  0/7 (0.00%)  0/5 (0.00%)  1/6 (16.67%) 
dry eyes  0/7 (0.00%)  0/5 (0.00%)  1/6 (16.67%) 
tearing (watery eyes)  0/7 (0.00%)  0/5 (0.00%)  2/6 (33.33%) 
Gastrointestinal disorders       
abdominal ascites  1/7 (14.29%)  0/5 (0.00%)  1/6 (16.67%) 
abdominal cramps  0/7 (0.00%)  1/5 (20.00%)  1/6 (16.67%) 
abdominal distention  1/7 (14.29%)  0/5 (0.00%)  1/6 (16.67%) 
abdominal pain  1/7 (14.29%)  0/5 (0.00%)  0/6 (0.00%) 
anticipatory nausea  1/7 (14.29%)  0/5 (0.00%)  0/6 (0.00%) 
bloody stools  1/7 (14.29%)  0/5 (0.00%)  0/6 (0.00%) 
constipation  1/7 (14.29%)  0/5 (0.00%)  1/6 (16.67%) 
diarrhea  3/7 (42.86%)  3/5 (60.00%)  2/6 (33.33%) 
difficulty swallowing  1/7 (14.29%)  0/5 (0.00%)  1/6 (16.67%) 
dry mouth  1/7 (14.29%)  0/5 (0.00%)  0/6 (0.00%) 
gastritis  1/7 (14.29%)  0/5 (0.00%)  0/6 (0.00%) 
gastrointestinal pain  1/7 (14.29%)  0/5 (0.00%)  0/6 (0.00%) 
heartburn  1/7 (14.29%)  0/5 (0.00%)  2/6 (33.33%) 
hematemesis  1/7 (14.29%)  0/5 (0.00%)  0/6 (0.00%) 
hemorrhoids  0/7 (0.00%)  1/5 (20.00%)  0/6 (0.00%) 
incontinent of stool  1/7 (14.29%)  1/5 (20.00%)  0/6 (0.00%) 
mucositis  0/7 (0.00%)  0/5 (0.00%)  1/6 (16.67%) 
nausea  4/7 (57.14%)  3/5 (60.00%)  5/6 (83.33%) 
rectal bleeding  1/7 (14.29%)  0/5 (0.00%)  0/6 (0.00%) 
stomach pain  0/7 (0.00%)  0/5 (0.00%)  1/6 (16.67%) 
stomach virus recovery  1/7 (14.29%)  0/5 (0.00%)  0/6 (0.00%) 
stomatitis  0/7 (0.00%)  0/5 (0.00%)  1/6 (16.67%) 
stool leakage  1/7 (14.29%)  0/5 (0.00%)  0/6 (0.00%) 
vomiting  3/7 (42.86%)  3/5 (60.00%)  5/6 (83.33%) 
General disorders       
asthenia  0/7 (0.00%)  0/5 (0.00%)  2/6 (33.33%) 
chest pain  1/7 (14.29%)  0/5 (0.00%)  1/6 (16.67%) 
chills  3/7 (42.86%)  0/5 (0.00%)  0/6 (0.00%) 
edema  2/7 (28.57%)  0/5 (0.00%)  1/6 (16.67%) 
fatigue  5/7 (71.43%)  2/5 (40.00%)  4/6 (66.67%) 
fever  3/7 (42.86%)  2/5 (40.00%)  1/6 (16.67%) 
Infections and infestations       
infection (cold symptoms)  0/7 (0.00%)  0/5 (0.00%)  1/6 (16.67%) 
sepsis  1/7 (14.29%)  1/5 (20.00%)  0/6 (0.00%) 
sore throat  0/7 (0.00%)  1/5 (20.00%)  1/6 (16.67%) 
upper respiratory infection  1/7 (14.29%)  0/5 (0.00%)  0/6 (0.00%) 
Investigations       
alk phos increased  3/7 (42.86%)  2/5 (40.00%)  3/6 (50.00%) 
ALT increased  3/7 (42.86%)  2/5 (40.00%)  3/6 (50.00%) 
AST increased  2/7 (28.57%)  2/5 (40.00%)  3/6 (50.00%) 
bilirubin increased  1/7 (14.29%)  2/5 (40.00%)  0/6 (0.00%) 
creatinine increased  3/7 (42.86%)  2/5 (40.00%)  2/6 (33.33%) 
lymphocytes decreased  7/7 (100.00%)  3/5 (60.00%)  6/6 (100.00%) 
neutrophils decreased  7/7 (100.00%)  3/5 (60.00%)  6/6 (100.00%) 
platelets decreased  6/7 (85.71%)  4/5 (80.00%)  6/6 (100.00%) 
PT increased  0/7 (0.00%)  3/5 (60.00%)  2/6 (33.33%) 
PTT increased  3/7 (42.86%)  2/5 (40.00%)  3/6 (50.00%) 
WBC decreased  7/7 (100.00%)  5/5 (100.00%)  6/6 (100.00%) 
weight loss  2/7 (28.57%)  0/5 (0.00%)  1/6 (16.67%) 
Metabolism and nutrition disorders       
anorexia  4/7 (57.14%)  0/5 (0.00%)  3/6 (50.00%) 
dehydration  1/7 (14.29%)  1/5 (20.00%)  2/6 (33.33%) 
hyperglycemia  5/7 (71.43%)  4/5 (80.00%)  4/6 (66.67%) 
hyperkalemia  1/7 (14.29%)  0/5 (0.00%)  0/6 (0.00%) 
hyperphosphatemia  2/7 (28.57%)  0/5 (0.00%)  0/6 (0.00%) 
hypoalbuminemia  4/7 (57.14%)  3/5 (60.00%)  2/6 (33.33%) 
hypocalcemia  3/7 (42.86%)  3/5 (60.00%)  3/6 (50.00%) 
hypoglycemia (low)  0/7 (0.00%)  1/5 (20.00%)  0/6 (0.00%) 
hypokalemia  3/7 (42.86%)  3/5 (60.00%)  4/6 (66.67%) 
hypomagnesemia  2/7 (28.57%)  3/5 (60.00%)  1/6 (16.67%) 
hyponatremia  2/7 (28.57%)  2/5 (40.00%)  3/6 (50.00%) 
hypophosphatemia  1/7 (14.29%)  1/5 (20.00%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders       
back pain  0/7 (0.00%)  0/5 (0.00%)  1/6 (16.67%) 
knee pain  0/7 (0.00%)  0/5 (0.00%)  1/6 (16.67%) 
muscle aches  0/7 (0.00%)  0/5 (0.00%)  2/6 (33.33%) 
pain in groin  2/7 (28.57%)  0/5 (0.00%)  0/6 (0.00%) 
pressure in sternal area  0/7 (0.00%)  0/5 (0.00%)  1/6 (16.67%) 
stiffness in abdomen  1/7 (14.29%)  0/5 (0.00%)  0/6 (0.00%) 
weakness  1/7 (14.29%)  0/5 (0.00%)  0/6 (0.00%) 
Nervous system disorders       
dizziness  0/7 (0.00%)  1/5 (20.00%)  1/6 (16.67%) 
dysgeusia  0/7 (0.00%)  0/5 (0.00%)  2/6 (33.33%) 
headache  0/7 (0.00%)  1/5 (20.00%)  1/6 (16.67%) 
memory impairment (intermittent)  0/7 (0.00%)  0/5 (0.00%)  1/6 (16.67%) 
neuropathies  1/7 (14.29%)  0/5 (0.00%)  2/6 (33.33%) 
syncope  2/7 (28.57%)  0/5 (0.00%)  0/6 (0.00%) 
tremors  1/7 (14.29%)  0/5 (0.00%)  0/6 (0.00%) 
Psychiatric disorders       
anxiety  1/7 (14.29%)  0/5 (0.00%)  0/6 (0.00%) 
confusion  0/7 (0.00%)  0/5 (0.00%)  1/6 (16.67%) 
depression  0/7 (0.00%)  1/5 (20.00%)  0/6 (0.00%) 
insomnia  1/7 (14.29%)  0/5 (0.00%)  1/6 (16.67%) 
Renal and urinary disorders       
acute kidney injury  1/7 (14.29%)  0/5 (0.00%)  0/6 (0.00%) 
difficulty urinating  1/7 (14.29%)  0/5 (0.00%)  0/6 (0.00%) 
increased urination (including at night) (intermittent)  1/7 (14.29%)  0/5 (0.00%)  0/6 (0.00%) 
nocturia  1/7 (14.29%)  0/5 (0.00%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
congestion  0/7 (0.00%)  1/5 (20.00%)  0/6 (0.00%) 
cough  1/7 (14.29%)  1/5 (20.00%)  2/6 (33.33%) 
dyspnea  3/7 (42.86%)  0/5 (0.00%)  1/6 (16.67%) 
dyspnea on exertion  1/7 (14.29%)  0/5 (0.00%)  3/6 (50.00%) 
green mucous (nose)  0/7 (0.00%)  0/5 (0.00%)  1/6 (16.67%) 
head cold with nasal congestion  1/7 (14.29%)  0/5 (0.00%)  0/6 (0.00%) 
hiccups  2/7 (28.57%)  0/5 (0.00%)  1/6 (16.67%) 
hoarseness (int)  0/7 (0.00%)  0/5 (0.00%)  1/6 (16.67%) 
nose bleed (epistaxis)  0/7 (0.00%)  1/5 (20.00%)  1/6 (16.67%) 
post nasal drip  1/7 (14.29%)  0/5 (0.00%)  0/6 (0.00%) 
runny nose  1/7 (14.29%)  1/5 (20.00%)  1/6 (16.67%) 
stuffy nose  0/7 (0.00%)  0/5 (0.00%)  1/6 (16.67%) 
Skin and subcutaneous tissue disorders       
alopecia  1/7 (14.29%)  0/5 (0.00%)  4/6 (66.67%) 
bruising around port  0/7 (0.00%)  1/5 (20.00%)  0/6 (0.00%) 
dry skin  0/7 (0.00%)  0/5 (0.00%)  1/6 (16.67%) 
itching skin  1/7 (14.29%)  0/5 (0.00%)  0/6 (0.00%) 
jaundice  0/7 (0.00%)  1/5 (20.00%)  0/6 (0.00%) 
night sweats  1/7 (14.29%)  0/5 (0.00%)  0/6 (0.00%) 
pruritis  0/7 (0.00%)  0/5 (0.00%)  2/6 (33.33%) 
rash  0/7 (0.00%)  0/5 (0.00%)  1/6 (16.67%) 
rash (left ear)  0/7 (0.00%)  0/5 (0.00%)  1/6 (16.67%) 
skin redness, swelling, right arm (shoulder to elbow)  0/7 (0.00%)  1/5 (20.00%)  0/6 (0.00%) 
Vascular disorders       
flushing  0/7 (0.00%)  0/5 (0.00%)  2/6 (33.33%) 
hypotension  1/7 (14.29%)  1/5 (20.00%)  0/6 (0.00%) 
The P.I. and Astrazeneca decided not to move forward with the Phase II part of the study. Therefore the arms of Irinotecan, Cisplatin, Mitomycin C with Olaparib versus Irinotecan, Cisplatin, Mitomycin C without Olaparib will not be compared.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Thomas Brown
Organization: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phone: 410-502-5328
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT01296763     History of Changes
Other Study ID Numbers: J1070
RC2CA148346-01 ( U.S. NIH Grant/Contract )
NA_00032826 ( Other Identifier: JHMIRB )
First Submitted: January 21, 2011
First Posted: February 15, 2011
Results First Submitted: December 4, 2015
Results First Posted: March 22, 2016
Last Update Posted: March 22, 2016