Clinical trial · Interventional
BN80927 in Patients With Advanced Malignant Solid Tumors
A Phase I Dose Finding Study of BN80927 Administered as an Intravenous Infusion Once Every 3 Weeks in Patients With Advanced Malignant Solid Tumors
NCT01435096CI-TRIAL-00043743completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study was to determine the maximum tolerated dose and the recommended dose of BN80927 in patients with advanced malignant solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Solid Tumour | Malignant Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BN80927 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BN80927
- interventionNames
- Drug: BN80927
Primary outcomes (2)
- measure
- Maximum tolerated dose determined by incidence of dose limiting toxicity.
- timeFrame
- During cycle 1, up to 3 weeks
- measure
- Recommended dose determined by incidence of dose limiting toxicity.
- timeFrame
- During cycle 1, up to 3 weeks
Secondary outcomes (6)
- measure
- Tumour response assessment according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: All included patients: * Gave their written (personally signed and dated) informed consent * had histologically or cytologically documented malignant solid tumour * had received no more than three prior chemotherapy regimens * had failed the standard therapy or had no option of an active standard therapy * had an estimated survival time of greater than 3 months (according to the investigator's assessment) * had a World Health Organisation (WHO) performance status score ≤1 * were free from other serious concurrent disease * had adequate bone marrow function * had adequate liver function * had adequate renal function * who were female and of child-bearing potential must have had a negative result in a pre-study pregnancy test β-human-chorionic-gonadotrophin (β-HCG). Exclusion Criteria: No patient included: * was pregnant or lactating * was unable and/or unwilling to comply fully with the protocol and the study instructions; * presented with any concomitant condition, which could compromise the objectives of the study * had received an investigational drug within 30 days prior to study entry or was scheduled to require concurrent treatment with an experimental drug or treatment during the study * had received chemotherapy or hormonotherapy within 4 weeks of study entry, or had received chemotherapy with nitrosoureas or mitomycin-C within 6 weeks of study entry * had received any extensive palliative or curative radiotherapy (no more than 35% of their active bone marrow) within 2 weeks of study entry, or had not fully recovered from such treatment * had previously received a bone marrow transplant (BMT) or peripheral blood progenitor cells (PBPC) * had clinical evidence of major organ failure or brain metastases.
References
Publications (0)
Data not yet available
No reference posted for this study.