CDI-CS-003/SAKK 67/15: Eine Phase 1/2a Studie mit intravenösem BAL101553 verabreicht über 48 Stunden in erwachsenen Patienten mit fortgeschrittenen soliden Tumoren oder wiederkehrendem Glioblsatom

Drug: BAL101553;Drug: BAL101553 at MTD

Gender: All
Maximum age: N/A
Minimum age: 18 Years

Inclusion Criteria:

1. Age = 18 years

2. Phase 1: Patients with either histologically or cytologically confirmed advanced or
recurrent solid tumor, who failed standard therapy or for whom no effective standard
therapy is available.

Phase 2a: Patients with platinum-resistant/refractory ovarian, fallopian tube or
primary peritoneal cancer (high-grade serous, endometrioid, or carcinosarcoma
histotypes) or glioblastoma in first relapse.

3. Patients with solid tumors must have measurable disease according to Response
Evaluation Criteria in Solid Tumors [RECIST] v1.1.

Patients with recurrent glioblastoma must have measurable disease defined by
contrast-enhancing magnetic resonance imaging.

4. Life expectancy = 12 weeks

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

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

7. Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

1. Patients with 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 glioblastoma who have: received radiotherapy within 12 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, or have
been treated previously with bevacizumab.

2. Patients who have had prior exposure to BAL101553.

3. Peripheral neuropathy = CTCAE grade 2.

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

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

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

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

8. Other protocol-defined exclusion criteria may apply.