Trial Outcomes & Findings for Tandutinib Plus Bevacizumab to Treat Recurrent Brain Tumors (NCT NCT00667394)
NCT ID: NCT00667394
Last Updated: 2015-11-05
Results Overview
Percentage of participants with progression free survival at 6 months. Progression is defined as a 25% increase in the sum of all measurable lesions (or two largest lesions if too numerous) over the smallest sum observed (over baseline if no decrease), clear worsening of any evaluable disease, appearance of any new lesion/site, or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
6 months
Results posted on
2015-11-05
Participant Flow
Participant milestones
| Measure |
Tandutinib & Bevacizumab in GBM Patients
GBM (glioblastoma multiforme) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks.
|
Tandutinib & Bevacizumab in AG Patients
AG (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, and malignant astrocytoma NOS (not otherwise specified )) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
1
|
|
Overall Study
COMPLETED
|
37
|
1
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
Tandutinib & Bevacizumab in GBM Patients
GBM (glioblastoma multiforme) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks.
|
Tandutinib & Bevacizumab in AG Patients
AG (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, and malignant astrocytoma NOS (not otherwise specified )) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
0
|
|
Overall Study
Progressive disease
|
1
|
0
|
Baseline Characteristics
Tandutinib Plus Bevacizumab to Treat Recurrent Brain Tumors
Baseline characteristics by cohort
| Measure |
Tandutinib & Bevacizumab in GBM Patients
n=41 Participants
GBM (glioblastoma multiforme) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks.
|
Tandutinib & Bevacizumab in AG Patients
n=1 Participants
AG (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, and malignant astrocytoma NOS (not otherwise specified )) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
36 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Age, Continuous
|
54.16 years
STANDARD_DEVIATION 11.52 • n=99 Participants
|
63 years
STANDARD_DEVIATION 0 • n=107 Participants
|
54.37 years
STANDARD_DEVIATION 11.46 • n=206 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=99 Participants
|
1 participants
n=107 Participants
|
42 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPercentage of participants with progression free survival at 6 months. Progression is defined as a 25% increase in the sum of all measurable lesions (or two largest lesions if too numerous) over the smallest sum observed (over baseline if no decrease), clear worsening of any evaluable disease, appearance of any new lesion/site, or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Outcome measures
| Measure |
Tandutinib & Bevacizumab in GBM Patients
n=37 Participants
GBM (glioblastoma multiforme) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks.
|
Tandutinib & Bevacizumab in AG Patients
AG (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, and malignant astrocytoma NOS (not otherwise specified )) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks
|
|---|---|---|
|
Progression-free Survival at 6 Months
|
23 Percentage of participants
Interval 12.0 to 37.0
|
—
|
SECONDARY outcome
Timeframe: 45 monthsHere is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Outcome measures
| Measure |
Tandutinib & Bevacizumab in GBM Patients
n=41 Participants
GBM (glioblastoma multiforme) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks.
|
Tandutinib & Bevacizumab in AG Patients
n=1 Participants
AG (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, and malignant astrocytoma NOS (not otherwise specified )) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks
|
|---|---|---|
|
Number of Participants With Adverse Events
|
40 Participants
|
1 Participants
|
Adverse Events
Tandutinib & Bevacizumab in GBM Patients
Serious events: 15 serious events
Other events: 41 other events
Deaths: 0 deaths
Tandutinib & Bevacizumab in AG Patients
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tandutinib & Bevacizumab in GBM Patients
n=41 participants at risk
GBM (glioblastoma multiforme) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks.
|
Tandutinib & Bevacizumab in AG Patients
n=1 participants at risk
AG (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, and malignant astrocytoma NOS (not otherwise specified )) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks
|
|---|---|---|
|
General disorders
Death not associated with CTCAE term: Death Progression NOS
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, keratosis & dermal hematoma)
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Nervous system disorders
Hemorrhage, CNS
|
7.3%
3/41 • Number of events 3
|
0.00%
0/1
|
|
Vascular disorders
Hypertension
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Abdomen NOS
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Colon
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia)
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Pleura (empyema)
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Infections and infestations
Infection with unknown ANC::Lung (pneumonia)
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)::Extremity-lower
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Gastrointestinal disorders
Nausea
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Pain-Other (Specify, lower extremities)
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)::Whole body/generalized
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Nervous system disorders
Pain::Head/headache
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Gastrointestinal disorders
Perforation, GI::Stomach
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Investigations
Platelets
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Investigations
Prolonged QTc interval
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Psychiatric disorders
Psychosis (hallucinations/delusions)
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Nervous system disorders
Seizure
|
12.2%
5/41 • Number of events 7
|
0.00%
0/1
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Gastrointestinal disorders
Perforation, GI::Colon
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
Other adverse events
| Measure |
Tandutinib & Bevacizumab in GBM Patients
n=41 participants at risk
GBM (glioblastoma multiforme) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks.
|
Tandutinib & Bevacizumab in AG Patients
n=1 participants at risk
AG (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, and malignant astrocytoma NOS (not otherwise specified )) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks
|
|---|---|---|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
9.8%
4/41 • Number of events 6
|
0.00%
0/1
|
|
Investigations
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
39.0%
16/41 • Number of events 26
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Investigations
Alkaline phosphatase
|
14.6%
6/41 • Number of events 7
|
0.00%
0/1
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
4.9%
2/41 • Number of events 2
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Anorexia
|
4.9%
2/41 • Number of events 2
|
0.00%
0/1
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
9.8%
4/41 • Number of events 6
|
0.00%
0/1
|
|
Blood and lymphatic system disorders
Blood/Bone marrow - Other (Specify, elevated eosinophils)
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Investigations
Creatinine
|
4.9%
2/41 • Number of events 4
|
100.0%
1/1 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify,hyperpigmentation 1; laceration)
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Gastrointestinal disorders
Diarrhea
|
75.6%
31/41 • Number of events 40
|
100.0%
1/1 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
4.9%
2/41 • Number of events 2
|
0.00%
0/1
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
General disorders
Edema::head and neck
|
41.5%
17/41 • Number of events 21
|
0.00%
0/1
|
|
General disorders
Edema: limb
|
22.0%
9/41 • Number of events 9
|
0.00%
0/1
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
51.2%
21/41 • Number of events 30
|
0.00%
0/1
|
|
Vascular disorders
Flushing
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Gastrointestinal disorders
Gastritis (including bile reflux gastritis)
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hyperglycemia)
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Investigations
Hemoglobin
|
34.1%
14/41 • Number of events 22
|
100.0%
1/1 • Number of events 2
|
|
Renal and urinary disorders
Hemoglobinuria
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Gastrointestinal disorders
Hemorrhage, GI::Anus
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Gastrointestinal disorders
Hemorrhage, GI::Rectum
|
4.9%
2/41 • Number of events 2
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory::Nose
|
2.4%
1/41 • Number of events 1
|
100.0%
1/1 • Number of events 1
|
|
Eye disorders
Hemorrhage/Bleeding - Other (hemorrhage into sclera)
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Vascular disorders
Hypertension
|
39.0%
16/41 • Number of events 24
|
100.0%
1/1 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Infections and infestations
Infection with unknown ANC::Lip/perioral
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Eye disorders
Keratitis (corneal inflammatory/corneal ulceration)
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Investigations
Leukocytes (total WBC)
|
51.2%
21/41 • Number of events 69
|
0.00%
0/1
|
|
Vascular disorders
Lymphedema-related fibrosis
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Investigations
Lymphopenia
|
56.1%
23/41 • Number of events 73
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
14.6%
6/41 • Number of events 6
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
2.4%
1/41 • Number of events 4
|
0.00%
0/1
|
|
Eye disorders
Muscle weakness, generalized or specific area (not due to neuropathy)::Extraocular
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)::Extremity-lower
|
7.3%
3/41 • Number of events 5
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)::Whole body/generalized
|
17.1%
7/41 • Number of events 12
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
4.9%
2/41 • Number of events 2
|
0.00%
0/1
|
|
Gastrointestinal disorders
Nausea
|
53.7%
22/41 • Number of events 27
|
100.0%
1/1 • Number of events 1
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
31.7%
13/41 • Number of events 49
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Pain::Other (Specify, left arm (phlebotomy pain))
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Pain::Chest wall
|
7.3%
3/41 • Number of events 3
|
0.00%
0/1
|
|
Nervous system disorders
Pain::Head/headache
|
14.6%
6/41 • Number of events 7
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Pain::Muscle
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Pain::Neck
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Pain::Throat/pharynx/larynx
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Blood and lymphatic system disorders
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
36.6%
15/41 • Number of events 35
|
100.0%
1/1 • Number of events 3
|
|
Investigations
Platelets
|
41.5%
17/41 • Number of events 31
|
0.00%
0/1
|
|
Investigations
Prolonged QTc interval
|
51.2%
21/41 • Number of events 51
|
0.00%
0/1
|
|
Renal and urinary disorders
Proteinuria
|
43.9%
18/41 • Number of events 21
|
100.0%
1/1 • Number of events 2
|
|
Nervous system disorders
Pyramidal tract dysfunction (e.g., increased tone, hyperflexia, positive Babinski, decreased fine mo
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
14.6%
6/41 • Number of events 6
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
7.3%
3/41 • Number of events 3
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hypernatremia)
|
7.3%
3/41 • Number of events 4
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
4.9%
2/41 • Number of events 2
|
0.00%
0/1
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia::Sinus tachycardia
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
4.9%
2/41 • Number of events 4
|
0.00%
0/1
|
|
Eye disorders
Vision-blurred vision
|
9.8%
4/41 • Number of events 4
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
4.9%
2/41 • Number of events 2
|
0.00%
0/1
|
|
Gastrointestinal disorders
Vomiting
|
14.6%
6/41 • Number of events 6
|
0.00%
0/1
|
|
Investigations
Weight gain
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Investigations
Weight loss
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Wound complication, non-infectious
|
2.4%
1/41 • Number of events 1
|
0.00%
0/1
|
Additional Information
Dr. Katherine Warren
National Cancer Institute, National Institutes of Health
Phone: 301-435-4683
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place