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|NCT02895360 : Phase 1/2a Study of BAL101553 as 48-hour Infusions in Patients With Advanced Solid Tumors or Recurrent Glioblastoma|
|Phase||Phase 1/Phase 2|
|Ages||Min: 18 Years Max: N/A|
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
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.
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
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.
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02895360
| Link to official Clinicaltrials.gov listing