Phase 1/2a Study of BAL101553 as 48-hour Infusions in Patients With Advanced Solid Tumors or Recurrent Glioblastoma
Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT02895360 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BAL101553 (Drug); BAL101553 at MTD (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Basilea Pharmaceutica
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD) of BAL101553 |
70 | — |
| SECONDARY Safety and Tolerability of BAL101553 Treatment Based on Number of Patients With Related Treatment-emergent Adverse Events (TEAEs) in the Phase 1 and Phase 2a Safety Population at Various Dose Levels and Indication |
2; 2; 8; 3; 9; 4 | — |
| SECONDARY AUC of BAL101553 and BAL27862 |
1430; 1310; 2260; 1890; 3560; 3550 | — |
| SECONDARY Cmax of BAL101553 and BAL27862 |
43.0; 44.2; 69.3; 60.9; 119; 111 | — |
| SECONDARY Tmax of BAL101553 and BAL27862 |
39.0; 30.0; 29.0; 27.1; 4.00; 1.56 | — |
| SECONDARY Bioavailability of Daily Oral BAL101553 Measured by BAL27862 in Phase 1 |
1.11; 1.32; 0.796; 0.893 | — |
| SECONDARY Anti-tumor Activity of BAL101553 by Best Response Rate Per RECIST / RANO Criteria |
1; 0; 0; 0; 0; 0 | — |
Summary
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 years
- 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.
- 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.
- Life expectancy ≥ 12 weeks
- Acceptable organ and marrow function at baseline (protocol defined laboratory parameters)
- 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.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- 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.
- Patients who have had prior exposure to BAL101553.
- Peripheral neuropathy ≥ CTCAE grade 2.
- Uncontrolled intercurrent illness that would unduly increase the risk of toxicity or limit compliance with study requirements
- Systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg at the screening visit.
- Blood pressure (BP) combination treatment with more than two antihypertensive medications.
- Women who are pregnant or breast-feeding. Men or women of reproductive potential who are not willing to apply effective birth control.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02895360). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.