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A Phase 2 Study of PLX3397 in Patients With Recurrent Glioblastoma

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: NCT01349036
Recruitment Status : Terminated (Business Decision)
First Posted : May 6, 2011
Results First Posted : January 9, 2020
Last Update Posted : March 3, 2020
Sponsor:
Collaborator:
Plexxikon
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Recurrent Glioblastoma
Intervention Drug: PLX3397
Enrollment 38
Recruitment Details A total of 38 participants who met all inclusion and none of the exclusion criteria were enrolled and received the study drug.
Pre-assignment Details Enrollment planned to include approximately 40 participants (10 in Cohort 1 and 30 in Cohort 2) recruited from approximately 6 clinic sites.
Arm/Group Title PLX3397 - Cohort 1 (Surgical) PLX3397 - Cohort 2 (Non-surgical)
Hide Arm/Group Description Participants with recurrent glioblastoma who required reoperation were treated with PLX3397 for 7 days prior to surgery. Participants who received PLX3397 continuously on 28 day cycles.
Period Title: Overall Study
Started 14 24
Completed 0 0
Not Completed 14 24
Reason Not Completed
Disease progression             13             22
Other             1             0
Withdrawal by Subject             0             2
Arm/Group Title PLX3397 - Cohort 1 (Surgical) PLX3397 - Cohort 2 (Non-surgical) Total
Hide Arm/Group Description Participants with recurrent glioblastoma who required reoperation were treated with PLX3397 for 7 days prior to surgery. Participants with recurrent glioblastoma who received PLX3397 continuously on 28 day cycles. Total of all reporting groups
Overall Number of Baseline Participants 14 24 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 24 participants 38 participants
56.1  (8.6) 54.1  (11.7) 54.8  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 24 participants 38 participants
Female
6
  42.9%
7
  29.2%
13
  34.2%
Male
8
  57.1%
17
  70.8%
25
  65.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 24 participants 38 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   4.2%
1
   2.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
   4.2%
1
   2.6%
White
14
 100.0%
21
  87.5%
35
  92.1%
More than one race
0
   0.0%
1
   4.2%
1
   2.6%
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 14 participants 24 participants 38 participants
14 24 38
1.Primary Outcome
Title Summary of Response Rates in Participants on Treatment With PLX3397
Hide Description Response to treatment was evaluated using the Response Assessment in Neuro-Oncology (RANO) criteria. All participants were evaluated for progression free survival (PFS), and overall survival (OS). The six-month PFS rate was defined as the number of subjects with PFS of at least 6-month duration, with PFS measured from the first day of treatment (Cycle 1, Day 1) to the date of the first documented disease progression or date of death, whichever occurs first, over a 6-month period and evaluated using the Kaplan Meier method. The rate of OS was defined as the number of subjects that survived until study exit.
Time Frame 6 months post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Response rates were assessed in the modified intent-to-treat population.
Arm/Group Title Surgical Cohort 1 (N=14) Non-Surgical Cohort 2 (N=24)
Hide Arm/Group Description:
Participants with recurrent glioblastoma who were treated with PLX3397 in Cohort 1 (surgical).
Participants with recurrent glioblastoma who were treated with PLX3397 in Cohort 2 (non-surgical).
Overall Number of Participants Analyzed 13 22
Measure Type: Count of Participants
Unit of Measure: Participants
Six-month PFS rate
1
   7.7%
2
   9.1%
Overall survival
10
  76.9%
21
  95.5%
Complete response rate
0
   0.0%
0
   0.0%
Partial response rate
0
   0.0%
0
   0.0%
Stable disease rate
3
  23.1%
4
  18.2%
Progressive disease rate
10
  76.9%
18
  81.8%
Not Evaluable
1
   7.7%
2
   9.1%
2.Primary Outcome
Title Mean Plasma Pharmacokinetic Parameters of PLX3397 After Oral Administration of 1000 mg/Day - Cycle 1 Day 15
Hide Description A noncompartmental method of analysis was used to analyze the plasma concentrations of PLX3397. Mean plasma pharmacokinetic parameters, include time to maximum concentration (Tmax) and will be calculated from the Cycle 1, Day 15 values.
Time Frame Pre-dose and up to 6 post dose during cycle 1, Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PLX3397 - Cohort 1 (Surgical) PLX3397 - Cohort 2 (Non-surgical)
Hide Arm/Group Description:
Participants with recurrent glioblastoma who required reoperation were treated with PLX3397 for 7 days prior to surgery.
Participants who received PLX3397 continuously on 28 day cycles.
Overall Number of Participants Analyzed 11 21
Mean (Standard Deviation)
Unit of Measure: hours
2.09  (1.04) 1.71  (0.90)
3.Primary Outcome
Title Mean Plasma Pharmacokinetic Parameters of PLX3397 After Oral Administration of 1000 mg/Day - Cycle 1 Day 15
Hide Description A noncompartmental method of analysis was used to analyze the plasma concentrations of PLX3397. Mean plasma pharmacokinetic parameters include maximum concentration (Cmax) and will be calculated from the Cycle 1, Day 15 values.
Time Frame Pre-dose and up to 6 post dose during cycle 1, Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PLX3397 - Cohort 1 (Surgical) PLX3397 - Cohort 2 (Non-surgical)
Hide Arm/Group Description:
Participants with recurrent glioblastoma who required reoperation were treated with PLX3397 for 7 days prior to surgery.
Participants who received PLX3397 continuously on 28 day cycles.
Overall Number of Participants Analyzed 11 21
Mean (Standard Deviation)
Unit of Measure: ng/mL
7760  (2330) 8030  (2790)
4.Primary Outcome
Title Mean Plasma Pharmacokinetic Parameters of PLX3397 After Oral Administration of 1000 mg/Day - Cycle 1 Day 15
Hide Description A noncompartmental method of analysis was used to analyze the plasma concentrations of PLX3397. Mean plasma pharmacokinetic parameters include an assessment of area under the curve over 0-4 hours (AUC0-4), and will be calculated from the Cycle 1, Day 15 values.
Time Frame Pre-dose and up to 6 post dose during cycle 1, Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PLX3397 - Cohort 1 (Surgical) PLX3397 - Cohort 2 (Non-surgical)
Hide Arm/Group Description:
Participants with recurrent glioblastoma who required reoperation were treated with PLX3397 for 7 days prior to surgery.
Participants who received PLX3397 continuously on 28 day cycles.
Overall Number of Participants Analyzed 11 21
Mean (Standard Deviation)
Unit of Measure: hr*ng/mL
24900  (6700) 26100  (9260)
5.Primary Outcome
Title Mean Plasma Pharmacokinetic Parameters of PLX3397 After Oral Administration of 1000 mg/Day - Cycle 1 Day 15
Hide Description A noncompartmental method of analysis was used to analyze the plasma concentrations of PLX3397. Mean plasma pharmacokinetic parameters include an assessment of area under the curve over 0-6 hours (AUC0-6), and will be calculated from the Cycle 1, Day 15 values.
Time Frame Pre-dose and up to 6 post dose during cycle 1, Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PLX3397 - Cohort 1 (Surgical) PLX3397 - Cohort 2 (Non-surgical)
Hide Arm/Group Description:
Participants with recurrent glioblastoma who required reoperation were treated with PLX3397 for 7 days prior to surgery.
Participants who received PLX3397 continuously on 28 day cycles.
Overall Number of Participants Analyzed 11 21
Mean (Standard Deviation)
Unit of Measure: hr*ng/mL
36100  (10000) 36900  (12200)
6.Secondary Outcome
Title Incidence (Number and Percentage of Participants) With Treatment-Emergent Adverse Events Related to Study Drug Occurring in ≥10% Participants During Treatment With PLX3397 (Safety Population)
Hide Description [Not Specified]
Time Frame Up to 1 year post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Safety events were assessed in the Safety Population.
Arm/Group Title PLX3397 - Cohort 1 (Surgical) PLX3397 - Cohort 2 (Non-surgical)
Hide Arm/Group Description:
All participants with recurrent glioblastoma who were treated with PLX3397 in Cohort 1 (surgical).
All participants with recurrent glioblastoma who were treated with PLX3397 in Cohort 2 (non-surgical).
Overall Number of Participants Analyzed 14 24
Measure Type: Count of Participants
Unit of Measure: Participants
Any Event
12
  85.7%
22
  91.7%
Fatigue
6
  42.9%
14
  58.3%
Constipation
3
  21.4%
1
   4.2%
Nausea
1
   7.1%
3
  12.5%
Hair color changes
2
  14.3%
4
  16.7%
Aspartate aminotransferase increased
3
  21.4%
3
  12.5%
Alanine aminotransferase increased
2
  14.3%
3
  12.5%
Decreased appetite
3
  21.4%
3
  12.5%
Headache
1
   7.1%
3
  12.5%
Pyrexia
2
  14.3%
1
   4.2%
Dry Mouth
2
  14.3%
0
   0.0%
Rash
2
  14.3%
1
   4.2%
Neutropenia
0
   0.0%
3
  12.5%
Lymphopenia
2
  14.3%
0
   0.0%
Blood Lactate Dehydrogenase Increased
2
  14.3%
1
   4.2%
Hypertension
2
  14.3%
0
   0.0%
Time Frame Adverse event data were collected from after the first dose to 28 days after the last dose.
Adverse Event Reporting Description Adverse events that emerge (or worsen) after the first dose of study drug and within 28 days after the last dose.
 
Arm/Group Title PLX3397 - Cohort 1 (Surgical) PLX3397 - Cohort 2 (Non-surgical)
Hide Arm/Group Description Participants with recurrent glioblastoma who required reoperation were treated with PLX3397 for 7 days prior to surgery. Participants who received PLX3397 continuously on 28 day cycles.
All-Cause Mortality
PLX3397 - Cohort 1 (Surgical) PLX3397 - Cohort 2 (Non-surgical)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   1/24 (4.17%) 
Hide Serious Adverse Events
PLX3397 - Cohort 1 (Surgical) PLX3397 - Cohort 2 (Non-surgical)
Affected / at Risk (%) Affected / at Risk (%)
Total   8/14 (57.14%)   11/24 (45.83%) 
Blood and lymphatic system disorders     
Anaemia  1  0/14 (0.00%)  1/24 (4.17%) 
Febrile neutropenia  1  0/14 (0.00%)  1/24 (4.17%) 
Gastrointestinal disorders     
Nausea  1  1/14 (7.14%)  0/24 (0.00%) 
Vomiting  1  1/14 (7.14%)  0/24 (0.00%) 
General disorders     
Oedema peripheral  1  1/14 (7.14%)  0/24 (0.00%) 
Infections and infestations     
Pneumonia  1  2/14 (14.29%)  0/24 (0.00%) 
Meningitis  1  1/14 (7.14%)  0/24 (0.00%) 
Investigations     
ALT increased  1  0/14 (0.00%)  1/24 (4.17%) 
AST increased  1  0/14 (0.00%)  1/24 (4.17%) 
INR increased  1  0/14 (0.00%)  1/24 (4.17%) 
WBC count decreased  1  0/14 (0.00%)  1/24 (4.17%) 
Metabolism and nutrition disorders     
Dehydration  1  0/14 (0.00%)  1/24 (4.17%) 
Hyponatraemia  1  0/14 (0.00%)  1/24 (4.17%) 
Musculoskeletal and connective tissue disorders     
Muscular weakness  1  1/14 (7.14%)  0/24 (0.00%) 
Nervous system disorders     
Convulsion  1  3/14 (21.43%)  5/24 (20.83%) 
Cerebrovascular accident  1  0/14 (0.00%)  1/24 (4.17%) 
Dysarthria  1  1/14 (7.14%)  0/24 (0.00%) 
Headache  1  0/14 (0.00%)  1/24 (4.17%) 
Hydrocephalus  1  0/14 (0.00%)  1/24 (4.17%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory failure  1  0/14 (0.00%)  1/24 (4.17%) 
Vascular disorders     
Hypertension  1  1/14 (7.14%)  0/24 (0.00%) 
Thrombosis  1  1/14 (7.14%)  0/24 (0.00%) 
1
Term from vocabulary, MedDRA (10.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PLX3397 - Cohort 1 (Surgical) PLX3397 - Cohort 2 (Non-surgical)
Affected / at Risk (%) Affected / at Risk (%)
Total   14/14 (100.00%)   22/24 (91.67%) 
Blood and lymphatic system disorders     
Leukopenia  1  1/14 (7.14%)  2/24 (8.33%) 
Neutropenia  1  0/14 (0.00%)  3/24 (12.50%) 
Febrile neutropenia  1  0/14 (0.00%)  2/24 (8.33%) 
Lymphopenia  1  2/14 (14.29%)  0/24 (0.00%) 
Thrombocytopenia  1  1/14 (7.14%)  1/24 (4.17%) 
Cardiac disorders     
Palpitations  1  1/14 (7.14%)  1/24 (4.17%) 
Ear and labyrinth disorders     
Deafness  1  1/14 (7.14%)  0/24 (0.00%) 
Ear congestion  1  1/14 (7.14%)  0/24 (0.00%) 
Tinnitus  1  1/14 (7.14%)  0/24 (0.00%) 
Endocrine disorders     
Cushingoid  1  1/14 (7.14%)  0/24 (0.00%) 
Eye disorders     
Periorbital oedema  1  1/14 (7.14%)  2/24 (8.33%) 
Lacrimation increased  1  2/14 (14.29%)  0/24 (0.00%) 
Vision blurred  1  1/14 (7.14%)  1/24 (4.17%) 
Diplopia  1  1/14 (7.14%)  0/24 (0.00%) 
Eye disorder  1  1/14 (7.14%)  0/24 (0.00%) 
Gastrointestinal disorders     
Nausea  1  6/14 (42.86%)  3/24 (12.50%) 
Constipation  1  5/14 (35.71%)  1/24 (4.17%) 
Diarrhoea  1  3/14 (21.43%)  1/24 (4.17%) 
Vomiting  1  2/14 (14.29%)  2/24 (8.33%) 
Abdominal pain  1  1/14 (7.14%)  2/24 (8.33%) 
Dry mouth  1  3/14 (21.43%)  0/24 (0.00%) 
Stomatitis  1  1/14 (7.14%)  1/24 (4.17%) 
General disorders     
Fatigue  1  7/14 (50.00%)  14/24 (58.33%) 
Pyrexia  1  5/14 (35.71%)  2/24 (8.33%) 
Gait disturbance  1  2/14 (14.29%)  2/24 (8.33%) 
Oedema  1  1/14 (7.14%)  0/24 (0.00%) 
Oedema peripheral  1  1/14 (7.14%)  0/24 (0.00%) 
Immune system disorders     
Hypersensitivity  1  1/14 (7.14%)  0/24 (0.00%) 
Seasonal allergy  1  1/14 (7.14%)  0/24 (0.00%) 
Infections and infestations     
Oral candidiasis  1  1/14 (7.14%)  1/24 (4.17%) 
Pneumonia  1  2/14 (14.29%)  0/24 (0.00%) 
Urinary tract infection  1  2/14 (14.29%)  0/24 (0.00%) 
Candidiasis  1  1/14 (7.14%)  0/24 (0.00%) 
Clostridium difficile colitis  1  1/14 (7.14%)  0/24 (0.00%) 
Meningitis  1  1/14 (7.14%)  0/24 (0.00%) 
Otitis externa  1  1/14 (7.14%)  0/24 (0.00%) 
Skin candida  1  1/14 (7.14%)  0/24 (0.00%) 
Upper respiratory tract infection  1  1/14 (7.14%)  0/24 (0.00%) 
Injury, poisoning and procedural complications     
Procedural pain  1  2/14 (14.29%)  1/24 (4.17%) 
Contusion  1  2/14 (14.29%)  0/24 (0.00%) 
Fall  1  2/14 (14.29%)  0/24 (0.00%) 
Incision site pain  1  2/14 (14.29%)  0/24 (0.00%) 
Pseudomeningocele  1  1/14 (7.14%)  0/24 (0.00%) 
Micturition urgency  1  0/14 (0.00%)  2/24 (8.33%) 
Investigations     
Aspartate aminotransferase increased  1  3/14 (21.43%)  3/24 (12.50%) 
Alanine aminotransferase increased  1  2/14 (14.29%)  3/24 (12.50%) 
Blood alkaline phosphatase increased  1  1/14 (7.14%)  2/24 (8.33%) 
Blood lactate dehydrogenase increased  1  2/14 (14.29%)  1/24 (4.17%) 
Neutrophil count decreased  1  1/14 (7.14%)  1/24 (4.17%) 
White blood cell count decreased  1  0/14 (0.00%)  2/24 (8.33%) 
Blood albumin decreased  1  1/14 (7.14%)  0/24 (0.00%) 
Haemoglobin decreased  1  1/14 (7.14%)  0/24 (0.00%) 
Weight decreased  1  1/14 (7.14%)  0/24 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  6/14 (42.86%)  3/24 (12.50%) 
Dehydration  1  2/14 (14.29%)  3/24 (12.50%) 
Hyponatraemia  1  2/14 (14.29%)  2/24 (8.33%) 
Hypocalcaemia  1  2/14 (14.29%)  1/24 (4.17%) 
Hypokalaemia  1  1/14 (7.14%)  1/24 (4.17%) 
Hyperglycaemia  1  1/14 (7.14%)  0/24 (0.00%) 
Hypoglycaemia  1  1/14 (7.14%)  0/24 (0.00%) 
Musculoskeletal and connective tissue disorders     
Muscular weakness  1  2/14 (14.29%)  2/24 (8.33%) 
Arthralgia  1  1/14 (7.14%)  1/24 (4.17%) 
Muscle spasms  1  2/14 (14.29%)  0/24 (0.00%) 
Myalgia  1  0/14 (0.00%)  2/24 (8.33%) 
Pain in extremity  1  1/14 (7.14%)  1/24 (4.17%) 
Back pain  1  1/14 (7.14%)  0/24 (0.00%) 
Tendon disorder  1  1/14 (7.14%)  0/24 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Seborrhoeic keratosis  1  1/14 (7.14%)  0/24 (0.00%) 
Nervous system disorders     
Headache  1  6/14 (42.86%)  8/24 (33.33%) 
Convulsion  1  4/14 (28.57%)  4/24 (16.67%) 
Dizziness  1  5/14 (35.71%)  2/24 (8.33%) 
Hemiparesis  1  2/14 (14.29%)  3/24 (12.50%) 
Aphasia  1  3/14 (21.43%)  1/24 (4.17%) 
Memory impairment  1  2/14 (14.29%)  2/24 (8.33%) 
Amnesia  1  1/14 (7.14%)  2/24 (8.33%) 
Hemianopia  1  2/14 (14.29%)  1/24 (4.17%) 
Psychomotor skills impaired  1  1/14 (7.14%)  2/24 (8.33%) 
Ataxia  1  0/14 (0.00%)  2/24 (8.33%) 
Dysarthria  1  1/14 (7.14%)  1/24 (4.17%) 
Dysgeusia  1  2/14 (14.29%)  0/24 (0.00%) 
Hydrocephalus  1  1/14 (7.14%)  1/24 (4.17%) 
Paraesthesia  1  1/14 (7.14%)  1/24 (4.17%) 
Peripheral motor neuropathy  1  1/14 (7.14%)  1/24 (4.17%) 
Somnolence  1  1/14 (7.14%)  1/24 (4.17%) 
Tremor  1  2/14 (14.29%)  0/24 (0.00%) 
Dyaesthesia  1  1/14 (7.14%)  0/24 (0.00%) 
Partial seizures  1  1/14 (7.14%)  0/24 (0.00%) 
Pyramidal tract syndrome  1  1/14 (7.14%)  0/24 (0.00%) 
Sinus headache  1  1/14 (7.14%)  0/24 (0.00%) 
Psychiatric disorders     
Confusional state  1  2/14 (14.29%)  2/24 (8.33%) 
Anxiety  1  2/14 (14.29%)  0/24 (0.00%) 
Insomnia  1  2/14 (14.29%)  0/24 (0.00%) 
Bradyphrenia  1  1/14 (7.14%)  0/24 (0.00%) 
Delirium  1  1/14 (7.14%)  0/24 (0.00%) 
Mental status changes  1  1/14 (7.14%)  0/24 (0.00%) 
Sleep disorder  1  1/14 (7.14%)  0/24 (0.00%) 
Renal and urinary disorders     
Urinary incontinence  1  1/14 (7.14%)  3/24 (12.50%) 
Reproductive system and breast disorders     
Breast pain  1  1/14 (7.14%)  0/24 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  2/14 (14.29%)  1/24 (4.17%) 
Oropharyngeal pain  1  1/14 (7.14%)  1/24 (4.17%) 
Hiccups  1  1/14 (7.14%)  0/24 (0.00%) 
Skin and subcutaneous tissue disorders     
Hair colour changes  1  2/14 (14.29%)  4/24 (16.67%) 
Rash  1  2/14 (14.29%)  1/24 (4.17%) 
Skin hypopigmentation  1  1/14 (7.14%)  2/24 (8.33%) 
Dry skin  1  0/14 (0.00%)  2/24 (8.33%) 
Pruritus  1  0/14 (0.00%)  2/24 (8.33%) 
Alopecia  1  1/14 (7.14%)  0/24 (0.00%) 
Erythema multiforme  1  1/14 (7.14%)  0/24 (0.00%) 
Night sweats  1  1/14 (7.14%)  0/24 (0.00%) 
Petechiae  1  1/14 (7.14%)  0/24 (0.00%) 
Purpura  1  1/14 (7.14%)  0/24 (0.00%) 
Rash maculo-papular  1  1/14 (7.14%)  0/24 (0.00%) 
Rash papular  1  1/14 (7.14%)  0/24 (0.00%) 
Skin odour abnormal  1  1/14 (7.14%)  0/24 (0.00%) 
Vascular disorders     
Hypertension  1  4/14 (28.57%)  6/24 (25.00%) 
Deep vein thrombosis  1  1/14 (7.14%)  0/24 (0.00%) 
Thrombosis  1  1/14 (7.14%)  0/24 (0.00%) 
1
Term from vocabulary, MedDRA (10.1)
Indicates events were collected by systematic assessment
Study was terminated due to results noted in primary outcome measure 1. The sponsor felt that the PFS 6 goal of 25% (Lamborn, 2008) was unlikely to be met upon further enrollment.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
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Name/Title: Study Director
Organization: Daiichi Sankyo Inc.
Phone: 908-992-6400
EMail: CTRinfo@dsi.com
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Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT01349036    
Other Study ID Numbers: PLX108-04
First Submitted: May 4, 2011
First Posted: May 6, 2011
Results First Submitted: August 21, 2019
Results First Posted: January 9, 2020
Last Update Posted: March 3, 2020