Clinical Trial Details
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NCT02490800 : Phase 1/2a Study of Oral BAL101553 in Adult Patients With Solid Tumors or Glioblastoma or High-grade Glioma
PhasePhase 1/Phase 2
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

1. Age = 18 years

2. Patients who have either of the following:

1. a histologically- or cytologically confirmed advanced or recurrent solid tumor,
who failed standard therapy, or for whom no effective standard therapy is
available to them

2. histologically-confirmed GBM or high-grade glioma, with progressive or recurrent
disease after prior radiotherapy, with or without chemotherapy. This will also
include patients with histologically-confirmed low-grade glioma who present with
unequivocal evidence by imaging of transformation to high-grade glioma/GBM.

3. Patients with advanced solid tumors must have measurable disease or non-measurable
prostate or ovarian cancer that can be followed by prostate specific antigen (PSA) or
cancer antigen-125 (CA- 125).

Patients with glioblastoma or high-grade glioma must have measurable disease, defined
by contrast-enhancing MRI. Patients with previous lowgrade glioma that progressed
after prior radiotherapy and are found to have high-grade glioma/GBM by biopsy or

4. Life expectancy = 12 weeks

5. Acceptable organ and marrow function at baseline (protocol defined laboratory

6. Patients with advanced solid tumors must have an Eastern Cooperative Oncology Group
(ECOG) performance status = 1 and patients with recurrent or progressive glioblastoma
must have an Eastern Cooperative Oncology Group (ECOG) performance status = 2.

7. Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

1. Patients with advanced or recurrent solid tumors who have received chemotherapy,
radiotherapy, immunotherapy, or investigational agents within 4 weeks prior to
starting study drug or who have not recovered from side effects of prior therapies.

Patients with recurrent or progressive GBM or high-grade glioma who have: received
radiotherapy within 6 weeks, unless there is a new area of enhancement consistent with
recurrent tumor outside the radiation field, or there is histological confirmation of
unequivocal tumor progression; received administration of prior antitumor chemotherapy
within 4 weeks, or within 6 weeks for nitrosoureas; undergone surgical resection
within 4 weeks or a stereotactic biopsy/core biopsy within 1 week prior to starting
study drug.

2. Patients who have had prior exposure to BAL1015533.

3. Inability to swallow oral medication

4. Change in steroid dose in GBM or high-grade glioma patients within 5 days prior to
first study-drug administration.

5. Patients with gastrointestinal disease or those who have had a procedure that is
expected to interfere with the oral absorption or tolerance of BAL101553

6. Symptomatic brain metastases or leptomeningeal disease, indicative of active disease,
in patients with advanced or recurrent solid tumors.

7. Peripheral neuropathy = CTCAE grade 2.

8. Uncontrolled intercurrent illness that would unduly increase the risk of toxicity or
limit compliance with study requirements

9. Systolic blood pressure (SBP) = 140 mmHg or diastolic blood pressure (DBP) = 90 mmHg
at the screening visit.

10. Blood pressure (BP) combination treatment with more than two antihypertensive

11. Women who are pregnant or breast-feeding. Men or women of reproductive potential who
are not willing to apply effective birth control

12. Other protocol-defined exclusion criteria may apply.
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