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Bosutinib in Adult Patients With Recurrent Glioblastoma

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ClinicalTrials.gov Identifier: NCT01331291
Recruitment Status : Completed
First Posted : April 8, 2011
Results First Posted : June 20, 2016
Last Update Posted : July 25, 2016
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Pfizer
Information provided by (Responsible Party):
Tracy T. Batchelor, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Glioblastoma
Intervention Drug: bosutinib
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm A Arm B
Hide Arm/Group Description

Patients who are surgical candidates

bosutinib: Taken orally

Patients that are not surgical candidates

bosutinib: Taken orally

Period Title: Overall Study
Started 2 9
Completed 0 0
Not Completed 2 9
Reason Not Completed
Lack of Efficacy             2             8
Death             0             1
Arm/Group Title Arm A Arm B Total
Hide Arm/Group Description

Patients who are surgical candidates

bosutinib: Taken orally

Patients that are not surgical candidates

bosutinib: Taken orally

Total of all reporting groups
Overall Number of Baseline Participants 2 9 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 2 participants 9 participants 11 participants
60
(58 to 62)
44
(36 to 62)
52
(36 to 62)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 9 participants 11 participants
Female
0
   0.0%
4
  44.4%
4
  36.4%
Male
2
 100.0%
5
  55.6%
7
  63.6%
Prior Surgery   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2 participants 9 participants 11 participants
Gross Total Resection 1 6 7
Sub total Resection 0 3 3
No prior surgery 1 0 1
[1]
Measure Description: Surgery done at time of diagnosis with glioblastoma
Karnofsky Performance Status (KPS)   [1] 
Median (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 2 participants 9 participants 11 participants
80
(70 to 90)
90
(70 to 90)
90
(70 to 90)
[1]
Measure Description: A standard way of measuring the ability of cancer patients to perform ordinary tasks. The Karnofsky Performance Status scores range from 0 to 100. A higher score means the patient is better able to carry out daily activities. (0 being 'Dead' and 100 being 'Normal, no complaints; no evidence of disease'.)
Prior chemoradiation   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2 participants 9 participants 11 participants
2 9 11
[1]
Measure Description: Number of patients who previously received standard, initial therapy with temozolomide and radiation at diagnosis
1.Primary Outcome
Title Progression-Free Survival
Hide Description Assess progression-free survival at six months in patients with recurrent glioblastoma at first or second recurrence who are treated with continuous daily dosing of bosutinib (Arm B). Progression-free survival is measured from initiation of study treatment to date of progression.
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This outcome was only applicable to participants enrolled on Arm B.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:

Patients who are surgical candidates

bosutinib: Taken orally

Patients that are not surgical candidates

bosutinib: Taken orally

Overall Number of Participants Analyzed 0 9
Median (95% Confidence Interval)
Unit of Measure: weeks
7.71
(2.6 to 7.9)
2.Secondary Outcome
Title Intratumoral Concentration
Hide Description Assess the intratumoral concentration of bosutinib in recurrent glioblastoma patients who are candidates for surgical re-resection (ARM A).
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in Arm B were never eligible for this outcome measure. Because only two participants were enrolled to Arm A, this analysis was not done as there were not sufficient tumor samples to generate meaningful results.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:

Patients who are surgical candidates

bosutinib: Taken orally

Patients that are not surgical candidates

bosutinib: Taken orally

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Safety Profile
Hide Description Overall safety profile will be characterized by type, frequency, severity (as graded by NCI CTCAE), timing and relationship of study therapy of adverse events and laboratory abnormalities. Safety and tolerability will be measured by the proportion of patients who experience Grade 3 or higher Adverse Events that are possibly, probably or definitely related to bosutinib and the number of same Adverse Events per patient. Adverse Events will be summarized by treatment for each arm by the frequency of patients experiencing treatment emergent adverse events.
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:

Patients who are surgical candidates

bosutinib: Taken orally

Patients that are not surgical candidates

bosutinib: Taken orally

Overall Number of Participants Analyzed 2 9
Measure Type: Number
Unit of Measure: participants
Grade 3 treatment-emergent lymphopenia 0 1
Grade 3 treatment-emergent hypophosphatemia 0 1
4.Secondary Outcome
Title Anti-tumor Response
Hide Description Assess anti-tumor response in patients in Arm B using MacDonald criteria. There are four possible responses: complete response, partial response, stable disease, or progressive disease. Criteria are based on measurements of tumor dimension as visualized with a contrast-enhanced MRI.
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only Arm B participants were evaluable for this outcome measure
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:

Patients who are surgical candidates

bosutinib: Taken orally

Patients that are not surgical candidates

bosutinib: Taken orally

Overall Number of Participants Analyzed 0 9
Measure Type: Number
Unit of Measure: participants
Complete response 0
Partial response 0
Stable Disease 1
Progressive disease 8
Time Frame Adverse event data were followed for the duration of the participants' time on study; an average of two 28-day cycles (56 total days), with a range of one to six cycles.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Combined Arms
Hide Arm/Group Description Adverse Events were measured across all participants, regardless of arm.
All-Cause Mortality
Combined Arms
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Combined Arms
Affected / at Risk (%)
Total   6/11 (54.55%) 
Gastrointestinal disorders   
diarrhea * 1  1/11 (9.09%) 
nausea * 1  1/11 (9.09%) 
vomiting * 1  1/11 (9.09%) 
Infections and infestations   
lung infection * 1  1/11 (9.09%) 
Injury, poisoning and procedural complications   
fall * 1  1/11 (9.09%) 
Investigations   
lymphocyte count decreased * 1  1/11 (9.09%) 
Nervous system disorders   
seizure * 1  1/11 (9.09%) 
dizziness * 1  1/11 (9.09%) 
headache * 1  1/11 (9.09%) 
Skin and subcutaneous tissue disorders   
cellulitis * 1  1/11 (9.09%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Combined Arms
Affected / at Risk (%)
Total   11/11 (100.00%) 
Gastrointestinal disorders   
nausea * 1  5/11 (45.45%) 
diarrhea * 1  3/11 (27.27%) 
General disorders   
fatigue * 1  6/11 (54.55%) 
Infections and infestations   
lung infection * 1  2/11 (18.18%) 
Investigations   
lymphocyte count decreased * 1  8/11 (72.73%) 
elevated alanine aminotransferase * 1  5/11 (45.45%) 
elevated aspartate aminotransferase * 1  2/11 (18.18%) 
Metabolism and nutrition disorders   
hypophosphatemia * 1  4/11 (36.36%) 
Nervous system disorders   
seizure * 1  4/11 (36.36%) 
cerebral edema * 1  1/11 (9.09%) 
Skin and subcutaneous tissue disorders   
rash * 1  3/11 (27.27%) 
maculo-papular rash * 1  4/11 (36.36%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
This study met pre-specified criteria for early closure, as all 9 patients enrolled on Arm B demonstrated disease progression within 6 months.
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
Name/Title: Tracy T. Batchelor, MD
Organization: Massachusetts General Hospital
Phone: 617-643-1938
Responsible Party: Tracy T. Batchelor, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01331291     History of Changes
Other Study ID Numbers: 10-190
First Submitted: March 28, 2011
First Posted: April 8, 2011
Results First Submitted: June 9, 2016
Results First Posted: June 20, 2016
Last Update Posted: July 25, 2016