Trial Outcomes & Findings for A Phase II Trial of Sutent (Sunitinib; SU011248) for Recurrent Anaplastic Astrocytoma and Glioblastoma (NCT NCT00606008)

Last Updated: 2012-11-19

Results Overview

Complete Response: Disappearance of all lesions, disease signs and symptoms related to the tumor. Partial Response (PR): When compared with pretreatment measurements, a reduction of 50% decrease in the sum of the longest diameters of all target enhancing lesions, taking as reference the baseline sum of the longest diameter. Stable Disease: Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of the longest diameter since treatment started. Objective Progression or Relapse: Relative to pretreatment measurements, an increase in the sum of the diameters of any measured enhancing lesion by at least 25% increase in the sum of the longest diameters since the treatment started or the appearance of new enhancing lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

6 Months

Results posted on

2012-11-19

Participant Flow

Patients must have had pathologically or neuroradiographically recurrent AA or GB and prior pathologic confirmation of primary tumor histology. Patients with prior low-grade glioma were eligible if histological transformation to malignant astrocytic gliomas (MAG) was confirmed before enrollment.

Study patients were stratified by tumor histology (AAor GB).

Participant milestones

Participant milestones
Measure	Sutent Treatment Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break. Sunitinib Malate : Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study.
Overall Study STARTED	30
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Sutent Treatment Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break. Sunitinib Malate : Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study.
Overall Study Adverse Event	1
Overall Study Withdrawal by Subject	4

Baseline Characteristics

A Phase II Trial of Sutent (Sunitinib; SU011248) for Recurrent Anaplastic Astrocytoma and Glioblastoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sutent Treatment n=30 Participants Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break. Sunitinib Malate : Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age Continuous	52 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 Months

Population: All participants

Outcome measures

Outcome measures
Measure	Sutent Treatment n=30 Participants Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break. Sunitinib Malate : Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study.	AA Cohort Patients n=14 Participants Recurrent glioblastoma (GB) patients	GB Cohort Patients n=16 Participants Anaplastic astrocytoma (AA)patients
Number of Participants With Progression Free Survival (PFS) at 6 Months Utilizing McDonald Criteria for Response, Progression and Relapse	4 Participants	2 Participants	2 Participants

SECONDARY outcome

Timeframe: 12 Months

Population: All participants

To estimate best response rates (proportion of patients who ever had a radiographic response equal to or better than stable disease during course assessment).

Outcome measures

Outcome measures
Measure	Sutent Treatment n=30 Participants Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break. Sunitinib Malate : Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study.	AA Cohort Patients n=14 Participants Recurrent glioblastoma (GB) patients	GB Cohort Patients n=16 Participants Anaplastic astrocytoma (AA)patients
Best Overall Response	13 Participants	8 Participants	5 Participants

SECONDARY outcome

Timeframe: 12 Months

Population: All participants

To evaluate toxicities associated with sunitinib treatment (grade 3 and greater toxicities).

Outcome measures

Outcome measures
Measure	Sutent Treatment n=30 Participants Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break. Sunitinib Malate : Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study.	AA Cohort Patients n=14 Participants Recurrent glioblastoma (GB) patients	GB Cohort Patients n=16 Participants Anaplastic astrocytoma (AA)patients
Number of Participants With Related Grade 3 and Greater Adverse Events	11 Participants	6 Participants	5 Participants

Adverse Events

Sutent Treatment

Serious events: 11 serious events

Other events: 28 other events

Deaths: 0 deaths

AA Cohort Patients

Serious events: 6 serious events

Other events: 14 other events

Deaths: 0 deaths

GB Cohort Patients

Serious events: 5 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sutent Treatment n=30 participants at risk Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break. Sunitinib Malate : Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study.	AA Cohort Patients n=14 participants at risk Recurrent glioblastoma (GB) patients	GB Cohort Patients n=16 participants at risk Anaplastic astrocytoma (AA)patients
Blood and lymphatic system disorders Leukocytes (total WBC)	10.0% 3/30 • 4 years, 8 months Toxicity assessments were obtained after each cycle. Toxicity was graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Response evaluations were performed using modified Macdonald criteria. Serious Adverse Events: =/\> Grade 3 toxicities associated with sunitinib.	21.4% 3/14 • 4 years, 8 months Toxicity assessments were obtained after each cycle. Toxicity was graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Response evaluations were performed using modified Macdonald criteria. Serious Adverse Events: =/\> Grade 3 toxicities associated with sunitinib.	0.00% 0/16 • 4 years, 8 months Toxicity assessments were obtained after each cycle. Toxicity was graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Response evaluations were performed using modified Macdonald criteria. Serious Adverse Events: =/\> Grade 3 toxicities associated with sunitinib.
Blood and lymphatic system disorders Lymphopenia	3.3% 1/30 • 4 years, 8 months Toxicity assessments were obtained after each cycle. Toxicity was graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Response evaluations were performed using modified Macdonald criteria. Serious Adverse Events: =/\> Grade 3 toxicities associated with sunitinib.	7.1% 1/14 • 4 years, 8 months Toxicity assessments were obtained after each cycle. Toxicity was graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Response evaluations were performed using modified Macdonald criteria. Serious Adverse Events: =/\> Grade 3 toxicities associated with sunitinib.	0.00% 0/16 • 4 years, 8 months Toxicity assessments were obtained after each cycle. Toxicity was graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Response evaluations were performed using modified Macdonald criteria. Serious Adverse Events: =/\> Grade 3 toxicities associated with sunitinib.
Blood and lymphatic system disorders Platelets	13.3% 4/30 • 4 years, 8 months Toxicity assessments were obtained after each cycle. Toxicity was graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Response evaluations were performed using modified Macdonald criteria. Serious Adverse Events: =/\> Grade 3 toxicities associated with sunitinib.	14.3% 2/14 • 4 years, 8 months Toxicity assessments were obtained after each cycle. Toxicity was graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Response evaluations were performed using modified Macdonald criteria. Serious Adverse Events: =/\> Grade 3 toxicities associated with sunitinib.	12.5% 2/16 • 4 years, 8 months Toxicity assessments were obtained after each cycle. Toxicity was graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Response evaluations were performed using modified Macdonald criteria. Serious Adverse Events: =/\> Grade 3 toxicities associated with sunitinib.
General disorders Fatigue (asthenia, lethargy, malaise)	10.0% 3/30 • 4 years, 8 months Toxicity assessments were obtained after each cycle. Toxicity was graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Response evaluations were performed using modified Macdonald criteria. Serious Adverse Events: =/\> Grade 3 toxicities associated with sunitinib.	7.1% 1/14 • 4 years, 8 months Toxicity assessments were obtained after each cycle. Toxicity was graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Response evaluations were performed using modified Macdonald criteria. Serious Adverse Events: =/\> Grade 3 toxicities associated with sunitinib.	12.5% 2/16 • 4 years, 8 months Toxicity assessments were obtained after each cycle. Toxicity was graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Response evaluations were performed using modified Macdonald criteria. Serious Adverse Events: =/\> Grade 3 toxicities associated with sunitinib.
General disorders Death not associated with CTCAE term - disease progression NOS	3.3% 1/30 • 4 years, 8 months Toxicity assessments were obtained after each cycle. Toxicity was graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Response evaluations were performed using modified Macdonald criteria. Serious Adverse Events: =/\> Grade 3 toxicities associated with sunitinib.	7.1% 1/14 • 4 years, 8 months Toxicity assessments were obtained after each cycle. Toxicity was graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Response evaluations were performed using modified Macdonald criteria. Serious Adverse Events: =/\> Grade 3 toxicities associated with sunitinib.	0.00% 0/16 • 4 years, 8 months Toxicity assessments were obtained after each cycle. Toxicity was graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Response evaluations were performed using modified Macdonald criteria. Serious Adverse Events: =/\> Grade 3 toxicities associated with sunitinib.
Skin and subcutaneous tissue disorders Dermatology/skin-other	3.3% 1/30 • 4 years, 8 months Toxicity assessments were obtained after each cycle. Toxicity was graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Response evaluations were performed using modified Macdonald criteria. Serious Adverse Events: =/\> Grade 3 toxicities associated with sunitinib.	7.1% 1/14 • 4 years, 8 months Toxicity assessments were obtained after each cycle. Toxicity was graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Response evaluations were performed using modified Macdonald criteria. Serious Adverse Events: =/\> Grade 3 toxicities associated with sunitinib.	0.00% 0/16 • 4 years, 8 months Toxicity assessments were obtained after each cycle. Toxicity was graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Response evaluations were performed using modified Macdonald criteria. Serious Adverse Events: =/\> Grade 3 toxicities associated with sunitinib.
Skin and subcutaneous tissue disorders Rash: hand-foot skin reaction	6.7% 2/30 • 4 years, 8 months Toxicity assessments were obtained after each cycle. Toxicity was graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Response evaluations were performed using modified Macdonald criteria. Serious Adverse Events: =/\> Grade 3 toxicities associated with sunitinib.	14.3% 2/14 • 4 years, 8 months Toxicity assessments were obtained after each cycle. Toxicity was graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Response evaluations were performed using modified Macdonald criteria. Serious Adverse Events: =/\> Grade 3 toxicities associated with sunitinib.	0.00% 0/16 • 4 years, 8 months Toxicity assessments were obtained after each cycle. Toxicity was graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Response evaluations were performed using modified Macdonald criteria. Serious Adverse Events: =/\> Grade 3 toxicities associated with sunitinib.
General disorders Hemorrhage/bleeding-other	3.3% 1/30 • 4 years, 8 months Toxicity assessments were obtained after each cycle. Toxicity was graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Response evaluations were performed using modified Macdonald criteria. Serious Adverse Events: =/\> Grade 3 toxicities associated with sunitinib.	7.1% 1/14 • 4 years, 8 months Toxicity assessments were obtained after each cycle. Toxicity was graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Response evaluations were performed using modified Macdonald criteria. Serious Adverse Events: =/\> Grade 3 toxicities associated with sunitinib.	0.00% 0/16 • 4 years, 8 months Toxicity assessments were obtained after each cycle. Toxicity was graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Response evaluations were performed using modified Macdonald criteria. Serious Adverse Events: =/\> Grade 3 toxicities associated with sunitinib.
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	3.3% 1/30 • 4 years, 8 months Toxicity assessments were obtained after each cycle. Toxicity was graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Response evaluations were performed using modified Macdonald criteria. Serious Adverse Events: =/\> Grade 3 toxicities associated with sunitinib.	0.00% 0/14 • 4 years, 8 months Toxicity assessments were obtained after each cycle. Toxicity was graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Response evaluations were performed using modified Macdonald criteria. Serious Adverse Events: =/\> Grade 3 toxicities associated with sunitinib.	6.2% 1/16 • 4 years, 8 months Toxicity assessments were obtained after each cycle. Toxicity was graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Response evaluations were performed using modified Macdonald criteria. Serious Adverse Events: =/\> Grade 3 toxicities associated with sunitinib.
Gastrointestinal disorders Mucositis/stomatitis (functional/symptomatic) - anus	3.3% 1/30 • 4 years, 8 months Toxicity assessments were obtained after each cycle. Toxicity was graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Response evaluations were performed using modified Macdonald criteria. Serious Adverse Events: =/\> Grade 3 toxicities associated with sunitinib.	0.00% 0/14 • 4 years, 8 months Toxicity assessments were obtained after each cycle. Toxicity was graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Response evaluations were performed using modified Macdonald criteria. Serious Adverse Events: =/\> Grade 3 toxicities associated with sunitinib.	6.2% 1/16 • 4 years, 8 months Toxicity assessments were obtained after each cycle. Toxicity was graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Response evaluations were performed using modified Macdonald criteria. Serious Adverse Events: =/\> Grade 3 toxicities associated with sunitinib.
Metabolism and nutrition disorders ALT, SGPT	3.3% 1/30 • 4 years, 8 months Toxicity assessments were obtained after each cycle. Toxicity was graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Response evaluations were performed using modified Macdonald criteria. Serious Adverse Events: =/\> Grade 3 toxicities associated with sunitinib.	0.00% 0/14 • 4 years, 8 months Toxicity assessments were obtained after each cycle. Toxicity was graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Response evaluations were performed using modified Macdonald criteria. Serious Adverse Events: =/\> Grade 3 toxicities associated with sunitinib.	6.2% 1/16 • 4 years, 8 months Toxicity assessments were obtained after each cycle. Toxicity was graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Response evaluations were performed using modified Macdonald criteria. Serious Adverse Events: =/\> Grade 3 toxicities associated with sunitinib.
Metabolism and nutrition disorders AST, SGOT	3.3% 1/30 • 4 years, 8 months Toxicity assessments were obtained after each cycle. Toxicity was graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Response evaluations were performed using modified Macdonald criteria. Serious Adverse Events: =/\> Grade 3 toxicities associated with sunitinib.	0.00% 0/14 • 4 years, 8 months Toxicity assessments were obtained after each cycle. Toxicity was graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Response evaluations were performed using modified Macdonald criteria. Serious Adverse Events: =/\> Grade 3 toxicities associated with sunitinib.	6.2% 1/16 • 4 years, 8 months Toxicity assessments were obtained after each cycle. Toxicity was graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Response evaluations were performed using modified Macdonald criteria. Serious Adverse Events: =/\> Grade 3 toxicities associated with sunitinib.

Other adverse events

Additional Information

Dr. Edward Pan

H. Lee Moffitt Cancer Center and Research Institute

Phone: 813-745-3871

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place