Clinical Trials Logo

Clinical Trial Summary

This is a multicenter, open-label, Phase 1b/2 efficacy and safety study of Berubicin utilizing a Simon's 2-stage design to confirm the efficacy (or futility) of a single arm of Berubicin treatment, administered at the recommended Phase 2 dose (RP2D) identified in Phase 1 studies (7.5 mg/m2 Berubicin HCl), on the endpoint of ORR in up to approximately 61 patients. A central reader will determine the radiologic responses for each patient according to m RANO criteria. The responder criteria for this Simon's design will be based on objective response criteria defined as individual patients achieving CR or PR per m-RANO criteria within 6 months from baseline.


Clinical Trial Description

The planned minimum duration of the study for an individual patient is approximately 11 weeks as follows: - A 4-week Screening Period - A 3-week Treatment Period (ie, one 3 week treatment cycle) - A 4-week End-of-Treatment follow-up Period after the last dose The 3-week treatment cycles may be repeated in the absence of clinical and/or neurological deterioration, or unacceptable toxicity, and as long as both the patient and investigator agree that further therapy is in the patient's best interest. After the End-of-Treatment follow-up visit, patients will enter a Post-Study follow-Up Period of up to approximately 2 years. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04915404
Study type Interventional
Source WPD Pharmaceuticals Sp. z o.o.
Contact
Status Terminated
Phase Phase 1/Phase 2
Start date December 7, 2022
Completion date December 30, 2023

See also
  Status Clinical Trial Phase
Completed NCT00597493 - Ph. 2 Sorafenib + Protracted Temozolomide in Recurrent GBM Phase 2
Completed NCT00379470 - Effect of NovoTTF-100A in Recurrent Glioblastoma Multiforme (GBM) Phase 3
Recruiting NCT01737346 - Procarbazine and Lomustine in Recurrent Glioblastoma Phase 2
Active, not recruiting NCT01464177 - Hypofractionated Stereotactic Radiotherapy in Recurrent Glioblastoma Multiforme Phase 2
Active, not recruiting NCT00562419 - CT-322 in Treating Patients With Recurrent Glioblastoma Multiforme and Combination Therapy With Irinotecan Phase 2
Completed NCT00071539 - Safety and Efficacy Study to Treat Recurrent Grade 4 Malignant Brain Tumors Phase 2
Active, not recruiting NCT02062827 - Genetically Engineered HSV-1 Phase 1 Study for the Treatment of Recurrent Malignant Glioma Phase 1
Completed NCT00509301 - Safety & Radiation Distribution Study of Cotara® in Patients With Recurrent Glioblastoma Multiforme Phase 1
Recruiting NCT05868083 - The Safety and Efficacy of SNC-109 CAR-T Cells Therapy the Recurrent Glioblastoma Phase 1
Completed NCT01576666 - Phase Ib, Dose Escalation Study of Oral LDE225 in Combination With BKM120 in Patients With Advanced Solid Tumors Phase 1
Completed NCT01738646 - Ph II SAHA and Bevacizumab for Recurrent Malignant Glioma Patients Phase 2
Completed NCT00306618 - Safety and Efficacy Study of Panzem NCD to Treat Glioblastoma Phase 2
Completed NCT01934361 - Phase Ib/II Study of Buparlisib Plus Carboplatin or Lomustine in Patients With Recurrent Glioblastoma Multiforme Phase 1
Terminated NCT01756729 - Post-approval Study of NovoTTF-100A in Recurrent GBM Patients Phase 4
Completed NCT00747253 - Monteris AutoLITTâ„¢ FIM Safety Trial for Recurrent/Progressive Brain Tumors Phase 1
Completed NCT00883298 - Bi-weekly Temozolomide Plus Bevacizumab for Adult Patients With Recurrent Glioblastoma Multiforme Phase 2
Completed NCT00481455 - Phase 2 Study of Panzem Nanocrystal Colloidal Dispersion (NCD) in Combination With Fixed-Dose Temozolomide to Patients With Recurrent Glioblastoma Multiforme (GBM) Phase 2
Recruiting NCT03423628 - A Study to Assess the Safety and Tolerability of AZD1390 Given With Radiation Therapy in Patients With Brain Cancer Phase 1
Recruiting NCT04689087 - A Prospective, Open-label, Single-arm Clinical Study N/A