Clinical trial · Interventional
Study of Karenitecin (BNP1350) in Patients With Brain Tumors
Phase 2 Treatment of Adults With Primary Malignant Glioma With Karenitecin
NCT00062478CI-TRIAL-00043971completedPhase 2ClinicalTrials.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 is to evaluate safety and efficacy ofKarenitecin (BNP1350) as a treatment of adults with brain tumors.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Neoplasms | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Brain Tumors | Brain Neoplasm | ALIAS | 0.90 |
| Malignant Neoplasms, Brain | Malignant Neoplasm | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Karenitecin (BNP1350) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Karenitecin for intravenous use
- interventionNames
- Drug: Karenitecin (BNP1350)
Primary outcomes (1)
- measure
- Objective Tumor Response Rate
- timeFrame
- Randomization to end of treatment
Secondary outcomes (2)
- measure
- Overall Survival
- timeFrame
- Randomization to date of death due to any cause
- measure
- Overall Safety
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
* Confirmed diagnosis of a newly diagnosed glioblastoma multiforme or recurrent/progressive glioblastoma multiforme, anaplastic astrocytoma, or anaplastic oligodendroglioma. * Evidence of measurable recurrent or residual primary CNS neoplasm. * An interval of at least 3 weeks between prior surgical resection or 6 weeks between prior radiotherapy or chemotherapy, and enrollment on this protocol unless there is unequivocal evidence of tumor progression after surgery, radiotherapy, or chemotherapy. * Hematocrit \> 29%, ANC \> 1,500, platelets \> 125,000 * Serum creatinine \< 1.5 mg/dl, BUN \< 25 mg/dl, serum SGOT and bilirubin \< 1.5 times upper limit of normal * Negative pregnancy test for female patients
References
Publications (0)
Data not yet available
No reference posted for this study.