Trial Outcomes & Findings for Bosutinib in Adult Patients With Recurrent Glioblastoma (NCT NCT01331291)

Last Updated: 2016-07-25

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

36 participants

Primary outcome timeframe

2 years

Results posted on

2016-07-25

Participant Flow

Participant milestones

Participant milestones
Measure	Arm A Patients who are surgical candidates bosutinib: Taken orally	Arm B Patients that are not surgical candidates bosutinib: Taken orally
Overall Study STARTED	2	9
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	2	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A Patients who are surgical candidates bosutinib: Taken orally	Arm B Patients that are not surgical candidates bosutinib: Taken orally
Overall Study Lack of Efficacy	2	8
Overall Study Death	0	1

Baseline Characteristics

Bosutinib in Adult Patients With Recurrent Glioblastoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A n=2 Participants Patients who are surgical candidates bosutinib: Taken orally	Arm B n=9 Participants Patients that are not surgical candidates bosutinib: Taken orally	Total n=11 Participants Total of all reporting groups
Age, Continuous	60 years n=5 Participants	44 years n=7 Participants	52 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Prior Surgery Gross Total Resection	1 participants n=5 Participants	6 participants n=7 Participants	7 participants n=5 Participants
Prior Surgery Sub total Resection	0 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants
Prior Surgery No prior surgery	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Karnofsky Performance Status (KPS)	80 units on a scale n=5 Participants	90 units on a scale n=7 Participants	90 units on a scale n=5 Participants
Prior chemoradiation	2 participants n=5 Participants	9 participants n=7 Participants	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: This outcome was only applicable to participants enrolled on Arm B.

Outcome measures

Outcome measures
Measure	Arm A Patients who are surgical candidates bosutinib: Taken orally	Arm B n=9 Participants Patients that are not surgical candidates bosutinib: Taken orally
Progression-Free Survival	—	7.71 weeks Interval 2.6 to 7.9

SECONDARY outcome

Timeframe: 2 years

Population: 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.

Assess the intratumoral concentration of bosutinib in recurrent glioblastoma patients who are candidates for surgical re-resection (ARM A).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

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.

Outcome measures

Outcome measures
Measure	Arm A n=2 Participants Patients who are surgical candidates bosutinib: Taken orally	Arm B n=9 Participants Patients that are not surgical candidates bosutinib: Taken orally
Safety Profile Grade 3 treatment-emergent lymphopenia	0 participants	1 participants
Safety Profile Grade 3 treatment-emergent hypophosphatemia	0 participants	1 participants

SECONDARY outcome

Timeframe: 2 years

Population: Only Arm B participants were evaluable for this outcome measure

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.

Outcome measures

Outcome measures
Measure	Arm A Patients who are surgical candidates bosutinib: Taken orally	Arm B n=9 Participants Patients that are not surgical candidates bosutinib: Taken orally
Anti-tumor Response Complete response	—	0 participants
Anti-tumor Response Partial response	—	0 participants
Anti-tumor Response Stable Disease	—	1 participants
Anti-tumor Response Progressive disease	—	8 participants

Adverse Events

Combined Arms

Serious events: 6 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Combined Arms n=11 participants at risk Adverse Events were measured across all participants, regardless of arm.
Skin and subcutaneous tissue disorders cellulitis	9.1% 1/11 • 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.
Nervous system disorders seizure	9.1% 1/11 • 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.
Injury, poisoning and procedural complications fall	9.1% 1/11 • 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.
Investigations lymphocyte count decreased	9.1% 1/11 • 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.
Infections and infestations lung infection	9.1% 1/11 • 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.
Gastrointestinal disorders diarrhea	9.1% 1/11 • 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.
Gastrointestinal disorders nausea	9.1% 1/11 • 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.
Nervous system disorders dizziness	9.1% 1/11 • 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.
Gastrointestinal disorders vomiting	9.1% 1/11 • 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.
Nervous system disorders headache	9.1% 1/11 • 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.

Other adverse events

Other adverse events
Measure	Combined Arms n=11 participants at risk Adverse Events were measured across all participants, regardless of arm.
Investigations lymphocyte count decreased	72.7% 8/11 • 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.
General disorders fatigue	54.5% 6/11 • 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.
Gastrointestinal disorders nausea	45.5% 5/11 • 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.
Nervous system disorders seizure	36.4% 4/11 • 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.
Investigations elevated alanine aminotransferase	45.5% 5/11 • 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.
Gastrointestinal disorders diarrhea	27.3% 3/11 • 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.
Metabolism and nutrition disorders hypophosphatemia	36.4% 4/11 • 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.
Skin and subcutaneous tissue disorders rash	27.3% 3/11 • 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.
Infections and infestations lung infection	18.2% 2/11 • 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.
Investigations elevated aspartate aminotransferase	18.2% 2/11 • 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.
Nervous system disorders cerebral edema	9.1% 1/11 • 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.
Skin and subcutaneous tissue disorders maculo-papular rash	36.4% 4/11 • 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.

Additional Information

Tracy T. Batchelor, MD

Massachusetts General Hospital

Phone: 617-643-1938

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place