Clinical Trial Details
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NCT02540161 : Phase 2 Study of Sym004 for Adult Patients With Recurrent Glioblastoma
PhasePhase 2
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

1. Patients must have histologically confirmed diagnosis of World Health Organization
(WHO) grade 4 malignant glioma and radiographic evidence of recurrence or disease
progression (as defined by the Response Assessment in Neuro-Oncology (RANO) criteria
as a greater than 25% increase in the largest bi-dimensional product of enhancement or
a new enhancing lesion, or a significant increase in T2-weighted-Fluid-Attenuated
Inversion Recovery (T2/FLAIR) abnormality without another co-morbid cause);

2. Age = 18 years;

3. Karnofsky Performance Status = 70%;

4. No more than 3 prior progressions;

5. Cohort 1 only: Non-bevacizumab failure, i.e. either no prior bevacizumab or
bevacizumab stable/responder, which is defined as stable within 6 months of prior
treatment with bevacizumab without experiencing a bevacizumab adverse event of special
interest (AESI) while on a bevacizumab-containing regimen, such as:

1. = grade 3 hypertension not controlled by medication, hypertensive crisis, or
hypertensive encephalopathy

2. = grade 3 proteinuria that does not resolve or nephrotic syndrome

3. Any grade GI perforation

4. = grade 3 infusion-related reaction

5. = grade 3 woundhealing complications

6. = grade 3 hemorrhage or any grade central nervous system (CNS) hemorrhage or =
grade 2 hemoptysis

7. Any grade arterial thromboembolic event (e.g. myocardial infarction or cerebral
infarction) or = grade 3 venous thromboembolic event

8. Any grade posterior reversible encephalopathy syndrome (PRES)

9. = grade 3 congestive heart failure

10. = grade 2 non-gastrointestinal (GI) abscesses and fistulae;

6. Cohort 2 only: Prior progression on a bevacizumab-containing regimen (defined as
having progressed/grown through bevacizumab by RANO criteria within 2 months of prior
bevacizumab treatment);

7. Pathology consistent with Epidermal Growth Factor Receptor (EGFR)-amplification of
tumor (i.e. greater than 15% of cells exhibiting > 5 copies of EGFR loci); archival
tissue may be tested for EGFR status in a separate consent;

8. Absolute Neutrophil Count (ANC) = 1,000 cells/µl, platelets = 100,000 cells/µl,
hemoglobin = 9 g/dL;

9. Adequate renal function as indicated by the following:

1. Serum creatinine < 1.25 times upper limit of normal or calculated creatinine
clearance = 50 ml/min;

2. Urine dipstick for proteinuria < 2+ unless a 24-hour urine protein <1 g of
protein is demonstrated;

10. Adequate liver function as indicated by the following:

1. Total bilirubin = 1.6 mg/dL;

2. Aspartate transaminase/alanine transaminase (AST/ALT) = 2.5 x the upper limit of
normal (ULN);

11. Magnesium = 0.9 mg/dL;

12. For subjects on corticosteroids, they must be on a stable dose for 7 days prior to
anticipated start of study drug;

13. No evidence of > grade 1 active CNS hemorrhage on the baseline magnetic resonance
imaging (MRI) or X-ray computed tomography (CT) scan;

14. Signed informed consent approved by the Institutional Review Board prior to patient

15. If the patient is a sexually active female of child bearing potential whose partner is
male, or if the patient is a sexually active male whose partner is a female of child
bearing potential, the patient must agree to use appropriate contraceptive measures
for the duration of the treatment of the tumor and for 6 months afterwards as stated
in the informed consent. Female patients of child bearing potential must have a
negative serum pregnancy test within 48 hours of starting study treatment;

16. Fertile male subjects must agree to use a medically acceptable contraceptive method
(allowed methods of birth control include vasectomy or condom with spermicide) during
the trial and for a period of at least 6 months following the last administration of
trial drugs.

Exclusion Criteria:

1. Pregnancy or breastfeeding;

2. Prior treatment with EGFR-targeted therapy, including, but not limited to, the
following examples: Gilotrif® (afatinib),Tarceva® (erlotinib), Erbitux® (cetuximab),
Iressaâ„¢ (gefitinib), Vectibix® (panitumumab), Caprelsa® (vandetanib), Tykerb®
(lapatinib), CDX110, D2C7-immunotoxin;

3. Active infection requiring intravenous antibiotics within 7 days before enrollment;

4. Prior, unrelated malignancy requiring current active treatment with the exception of
cervical carcinoma in situ and adequately treated basal cell or squamous cell
carcinoma of the skin;

5. Less than 12 weeks from radiation therapy, unless progressive disease outside of the
radiation field or 2 progressive scans at least 4 weeks apart or histopathologic

6. Treated with immunotherapeutic agents, vaccines, or Mab therapy within 4 weeks before
enrollment, unless the patient has recovered from the expected toxic effects of such

7. Treated with alkylating agents within 4 weeks (6 weeks for nitrosoureas) before
enrollment or treated within 1 week before enrollment with daily or metronomic
chemotherapy, unless the patient has recovered from the expected toxic effects of such
therapy to their baseline or to grade 1;

8. Prior treatment (non-alkylating agents) within 2 weeks before enrollment, unless the
patient has recovered from the expected toxic effects of such therapy;

9. Known hypersensitivity reactions to any of the components of Sym004;

10. Known current drug abuse or alcohol abuse;

11. Known Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C infection.
Testing is not required as part of this study.
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