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Trial record 8 of 9 for:    Olaratumab | Recruiting, Active, not recruiting, Completed Studies | Cancer | Phase 2

Ramucirumab or Anti-PDGFR Alpha Monoclonal Antibody IMC-3G3 in Treating Patients With Recurrent Glioblastoma Multiforme

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: NCT00895180
Recruitment Status : Completed
First Posted : May 8, 2009
Results First Posted : March 29, 2017
Last Update Posted : December 27, 2017
Sponsor:
Collaborators:
National Cancer Institute (NCI)
ImClone LLC
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Adult Glioblastoma Multiforme
Interventions Biological: olaratumab
Biological: ramucirumab
Enrollment 80
Recruitment Details  
Pre-assignment Details The completers include those participants with progressive disease (PD) or those who died.
Arm/Group Title Group 1 Ramucirumab Group 2 Olaratumab
Hide Arm/Group Description Participants receive ramucirumab intravenously (IV) over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 40 40
Received at Least 1 Dose of Study Drug 40 40
Completed 40 40
Not Completed 0 0
Arm/Group Title Group 1 Ramucirumab Group 2 Olaratumab Total
Hide Arm/Group Description Participants receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Total of all reporting groups
Overall Number of Baseline Participants 40 40 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 40 participants 80 participants
51.4  (12.29) 51.6  (11.81) 51.5  (11.98)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
Female 12 16 28
Male 28 24 52
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
Hispanic or Latino
1
   2.5%
2
   5.0%
3
   3.8%
Not Hispanic or Latino
39
  97.5%
38
  95.0%
77
  96.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   2.5%
0
   0.0%
1
   1.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   2.5%
2
   5.0%
3
   3.8%
White
38
  95.0%
37
  92.5%
75
  93.8%
More than one race
0
   0.0%
1
   2.5%
1
   1.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants 40 participants 80 participants
40 40 80
1.Primary Outcome
Title Percentage of Participants Who Achieved Progression-Free Survival Rate at 6 Months (PFS-6)
Hide Description PFS was defined as the start of treatment to the earliest date of tumor progression or death from any cause based on the modified Response Assessment in Neuro-Oncology Group through the American Society of Clinical Oncology (RANO) criteria. Progression is defined by any of the following: ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration. RANO is a standardized response criteria using bi-dimensional measurements of the largest contrast-enhancing area (Macdonald, 1990).
Time Frame Start of treatment to PD or Death Up To 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug.
Arm/Group Title Group 1 Ramucirumab Group 2 Olaratumab
Hide Arm/Group Description:
Participants receive ramucirumab intravenously (IV) over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 40 40
Measure Type: Number
Unit of Measure: percentage of participants
12.5 7.5
2.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events as Assessed by NCI CTCAE v4.0 (National Cancer Institute-Common Terminology Criteria for Adverse Events)
Hide Description The number of participants who experienced serious adverse events (SAEs) that were considered to be related to ramucirumab or olaratumab. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
Time Frame Start of Treatment to End of Study (Up to 13 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug.
Arm/Group Title Group 1 Ramucirumab Group 2 Olaratumab
Hide Arm/Group Description:
Participants receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 40 40
Measure Type: Number
Unit of Measure: participants
SAE 13 14
Other adverse events (AEs) 38 39
3.Secondary Outcome
Title Percentage of Participants (Pts) With Complete Response (CR), Partial Response (PR) and Minor Response (MR) (Objective Response Rate [ORR])
Hide Description The pts achievement of both measurement and confirmation criteria for a status of CR, PR or MR based on the modified RANO criteria.CR requires all of the following:complete disappearance of all enhancing measurable and non-measurable disease sustained for at least 4 weeks (wks);no new lesions;no corticosteroids;and stable or improved clinically.PR requires all of the following:≥ 50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 wks;no new lesions;stable or reduced corticosteroid dose;and stable or improved clinically.MR requires ≥ 25% reduction in sum of products of the perpendicular diameters of all measureable enhancing lesions sustained for at least 4 wks and no new lesions or progression of non-measurable lesions. PD is defined by any of these: ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions;any new lesion;or clinical deterioration.
Time Frame Start of Treatment to PD Up To 20 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug.
Arm/Group Title Group 1 Ramucirumab Group 2 Olaratumab
Hide Arm/Group Description:
Participants receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 40 40
Measure Type: Number
Unit of Measure: percentage of participants
0 2.5
4.Secondary Outcome
Title Median Overall Survival (OS)
Hide Description OS is the time from the start of treatment to the date of death. Participants who had not expired by the data analysis cutoff date were censored at their last date known to be alive.
Time Frame Start of Treatment to Death Up To 27 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug. Participants censored in ramucirumab = 4 and olaratumab = 4.
Arm/Group Title Group 1 Ramucirumab Group 2 Olaratumab
Hide Arm/Group Description:
Participants receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 40 40
Median (95% Confidence Interval)
Unit of Measure: Weeks
49.5
(31.1 to 58.7)
34.3
(24.1 to 46.9)
5.Secondary Outcome
Title Pharmacokinetics (PK): Concentration Maximum (Cmax) and Concentration Minimum (Cmin) of Ramucirumab
Hide Description [Not Specified]
Time Frame Cycle 7, Day 1: Prior to Infusion,1 hour (hr) Post Infusion
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of ramucirumab and had evaluable PK data.
Arm/Group Title Group 1 Ramucirumab
Hide Arm/Group Description:
Participants receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: microgram/milliliter (μg/mL)
Cmin (n=5)
85.0
(25%)
Cmax (n=6)
396
(30%)
6.Secondary Outcome
Title PK: Cmax and Cmin of Olaratumab
Hide Description [Not Specified]
Time Frame Cycle 3, Day 1: Prior to Infusion, 1 hr Post Infusion
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of Olaratumab and had evaluable PK data.
Arm/Group Title Group 2 Olaratumab
Hide Arm/Group Description:
Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg/mL
Cmin (n=5)
145
(22%)
Cmax (n=5)
515
(23%)
7.Secondary Outcome
Title Pharmacodynamics (PD) Profiles
Hide Description [Not Specified]
Time Frame Cycle 7, Day 1: Prior to Infusion, 1 hr Post Infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed for pharmacodynamic profile as the plasma collection procedure in this study was not fit for this purpose.
Arm/Group Title Group 1 Ramucirumab Group 2 Olaratumab
Hide Arm/Group Description:
Participants receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Percentage of Participants With Anti-Olaratumab Antibodies (ADA)
Hide Description Percentage of Participants with Treatment Emergent (TE) anti-olaratumab antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20.
Time Frame Start of Treatment to 30-day Post Infusion Follow Up (Up to 6 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participant who had any amount of olaratumab and evaluable anti-olaratumab antibody data.
Arm/Group Title Group 2 Olaratumab
Hide Arm/Group Description:
Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 26
Measure Type: Number
Unit of Measure: percentage of participants
0
9.Secondary Outcome
Title Percentage of Participants With Anti-Ramucirumab Antibodies (ADA)
Hide Description Percentage of Participants with Treatment Emergent (TE) anti-ramucirumab antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20.
Time Frame Start of Treatment to 30-day Post Infusion Follow Up (Up to 6 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who had any amount of ramucirumab and evaluable anti-ramucirumab antibodies.
Arm/Group Title Group 1 Ramucirumab
Hide Arm/Group Description:
Participants receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: percentage of participants
3.1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1 Ramucirumab Group 2 Olaratumab
Hide Arm/Group Description Participants receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Group 1 Ramucirumab Group 2 Olaratumab
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group 1 Ramucirumab Group 2 Olaratumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/40 (32.50%)      14/40 (35.00%)    
Blood and lymphatic system disorders     
Anemia  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Thrombocytopenia  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Cardiac disorders     
Atrial fibrillation  1  0/40 (0.00%)  0 1/40 (2.50%)  1
Gastrointestinal disorders     
Gastric hemorrhage  1  1/40 (2.50%)  2 0/40 (0.00%)  0
Nausea  1  0/40 (0.00%)  0 1/40 (2.50%)  1
Vomiting  1  0/40 (0.00%)  0 1/40 (2.50%)  1
General disorders     
Fatigue  1  1/40 (2.50%)  1 1/40 (2.50%)  1
Gait disturbance  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Pyrexia  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Infections and infestations     
Bacteremia  1  0/40 (0.00%)  0 1/40 (2.50%)  1
Lung infection  1  0/40 (0.00%)  0 1/40 (2.50%)  1
Shunt infection  1  0/40 (0.00%)  0 1/40 (2.50%)  3
Urinary tract infection  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Injury, poisoning and procedural complications     
Fall  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Incorrect storage of drug  1  2/40 (5.00%)  2 0/40 (0.00%)  0
Medication error  1  2/40 (5.00%)  2 0/40 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration  1  0/40 (0.00%)  0 3/40 (7.50%)  3
Hyperglycemia  1  1/40 (2.50%)  2 0/40 (0.00%)  0
Hyponatremia  1  0/40 (0.00%)  0 1/40 (2.50%)  1
Musculoskeletal and connective tissue disorders     
Muscular weakness  1  1/40 (2.50%)  2 0/40 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasm progression  1  3/40 (7.50%)  3 1/40 (2.50%)  1
Nervous system disorders     
Brain edema  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Cerebral hematoma  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Cognitive disorder  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Convulsion  1  3/40 (7.50%)  3 1/40 (2.50%)  1
Depressed level of consciousness  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Encephalopathy  1  0/40 (0.00%)  0 1/40 (2.50%)  1
Hemorrhage intracranial  1  2/40 (5.00%)  2 1/40 (2.50%)  1
Headache  1  0/40 (0.00%)  0 1/40 (2.50%)  1
Hydrocephalus  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Vasogenic cerebral edema  1  0/40 (0.00%)  0 1/40 (2.50%)  1
Psychiatric disorders     
Depression  1  0/40 (0.00%)  0 1/40 (2.50%)  1
Mental status changes  1  0/40 (0.00%)  0 1/40 (2.50%)  2
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  0/40 (0.00%)  0 1/40 (2.50%)  1
Pulmonary embolism  1  2/40 (5.00%)  2 1/40 (2.50%)  1
Skin and subcutaneous tissue disorders     
Decubitus ulcer  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Vascular disorders     
Deep vein thrombosis  1  3/40 (7.50%)  3 2/40 (5.00%)  2
Hypertension  1  0/40 (0.00%)  0 1/40 (2.50%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1 Ramucirumab Group 2 Olaratumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   38/40 (95.00%)      39/40 (97.50%)    
Blood and lymphatic system disorders     
Thrombocytopenia  1  2/40 (5.00%)  2 4/40 (10.00%)  4
Endocrine disorders     
Cushingoid  1  4/40 (10.00%)  4 2/40 (5.00%)  2
Eye disorders     
Vision blurred  1  3/40 (7.50%)  3 2/40 (5.00%)  2
Gastrointestinal disorders     
Constipation  1  3/40 (7.50%)  3 6/40 (15.00%)  6
Diarrhea  1  5/40 (12.50%)  7 10/40 (25.00%)  17
Faecal incontinence  1  3/40 (7.50%)  3 0/40 (0.00%)  0
Nausea  1  8/40 (20.00%)  9 12/40 (30.00%)  20
Vomiting  1  5/40 (12.50%)  5 7/40 (17.50%)  9
General disorders     
Asthenia  1  3/40 (7.50%)  3 1/40 (2.50%)  1
Chills  1  2/40 (5.00%)  2 3/40 (7.50%)  3
Fatigue  1  19/40 (47.50%)  25 18/40 (45.00%)  24
Gait disturbance  1  6/40 (15.00%)  10 6/40 (15.00%)  7
Non-cardiac chest pain  1  2/40 (5.00%)  2 3/40 (7.50%)  3
Edema peripheral  1  6/40 (15.00%)  8 5/40 (12.50%)  6
Infections and infestations     
Upper respiratory tract infection  1  3/40 (7.50%)  4 3/40 (7.50%)  3
Urinary tract infection  1  3/40 (7.50%)  5 2/40 (5.00%)  2
Vaginal infection  1  1/12 (8.33%)  2 0/16 (0.00%)  0
Injury, poisoning and procedural complications     
Contusion  1  6/40 (15.00%)  7 2/40 (5.00%)  2
Fall  1  6/40 (15.00%)  9 4/40 (10.00%)  4
Investigations     
Weight increased  1  2/40 (5.00%)  2 4/40 (10.00%)  5
Metabolism and nutrition disorders     
Decreased appetite  1  3/40 (7.50%)  3 2/40 (5.00%)  2
Dehydration  1  2/40 (5.00%)  3 3/40 (7.50%)  3
Hypokalemia  1  3/40 (7.50%)  7 2/40 (5.00%)  2
Hypophosphatemia  1  1/40 (2.50%)  1 3/40 (7.50%)  16
Musculoskeletal and connective tissue disorders     
Arthralgia  1  2/40 (5.00%)  2 7/40 (17.50%)  10
Back pain  1  4/40 (10.00%)  4 6/40 (15.00%)  6
Muscle spasms  1  2/40 (5.00%)  2 3/40 (7.50%)  4
Muscular weakness  1  6/40 (15.00%)  6 6/40 (15.00%)  6
Myalgia  1  3/40 (7.50%)  3 2/40 (5.00%)  2
Pain in extremity  1  2/40 (5.00%)  2 5/40 (12.50%)  5
Nervous system disorders     
Aphasia  1  6/40 (15.00%)  9 5/40 (12.50%)  6
Balance disorder  1  3/40 (7.50%)  3 2/40 (5.00%)  2
Cognitive disorder  1  5/40 (12.50%)  7 1/40 (2.50%)  1
Convulsion  1  5/40 (12.50%)  6 4/40 (10.00%)  9
Disturbance in attention  1  3/40 (7.50%)  4 0/40 (0.00%)  0
Dizziness  1  5/40 (12.50%)  5 8/40 (20.00%)  9
Dysarthria  1  4/40 (10.00%)  4 1/40 (2.50%)  1
Headache  1  16/40 (40.00%)  21 12/40 (30.00%)  20
Hemiparesis  1  1/40 (2.50%)  1 4/40 (10.00%)  7
Hypoesthesia  1  3/40 (7.50%)  4 1/40 (2.50%)  1
Memory impairment  1  3/40 (7.50%)  3 4/40 (10.00%)  4
Tremor  1  4/40 (10.00%)  5 3/40 (7.50%)  3
Psychiatric disorders     
Anxiety  1  3/40 (7.50%)  3 2/40 (5.00%)  2
Confusional state  1  6/40 (15.00%)  7 3/40 (7.50%)  3
Insomnia  1  2/40 (5.00%)  2 8/40 (20.00%)  8
Renal and urinary disorders     
Proteinuria  1  0/40 (0.00%)  0 5/40 (12.50%)  10
Urinary incontinence  1  1/40 (2.50%)  2 3/40 (7.50%)  3
Reproductive system and breast disorders     
Amenorrhea  1  0/12 (0.00%)  0 1/16 (6.25%)  1
Dysmenorrhea  1  1/12 (8.33%)  1 0/16 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough  1  3/40 (7.50%)  5 5/40 (12.50%)  5
Dyspnea  1  2/40 (5.00%)  2 3/40 (7.50%)  4
Nasal congestion  1  1/40 (2.50%)  1 5/40 (12.50%)  5
Oropharyngeal pain  1  1/40 (2.50%)  3 3/40 (7.50%)  3
Skin and subcutaneous tissue disorders     
Rash  1  2/40 (5.00%)  2 7/40 (17.50%)  8
Vascular disorders     
Hypertension  1  2/40 (5.00%)  3 10/40 (25.00%)  21
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
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.
In accordance with the ABTC publication, JHU will submit the draft of any proposed publication to ImClone at least thirty (30) days prior to submission for publication and agrees to withhold any such submission for an additional period, not to exceed ninety (90) days to allow ImClone to file patent applications. If Confidential Information is in the publication, it will notify JHU, which will insure such Confidential Information is redacted.
Results Point of Contact
Name/Title: Dr. Jaishri Blakely
Organization: Sidney Kimmel Comprehensive Cancer Center
Phone: (410) 955-8893
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00895180     History of Changes
Other Study ID Numbers: ABTC-0901 CDR0000641230
U01CA137443 ( U.S. NIH Grant/Contract )
ABTC-0901
IMCL-CP-19-0801
First Submitted: May 7, 2009
First Posted: May 8, 2009
Results First Submitted: November 18, 2016
Results First Posted: March 29, 2017
Last Update Posted: December 27, 2017