Clinical Trials Logo

Clinical Trial Summary

Single-agent, open-label, multi-center sequential dose escalation and expansion study of BAL101553, administered as an intravenous (IV) infusion over 48 hours to adults with advanced or recurrent solid tumors or recurrent glioblastoma.


Clinical Trial Description

This is the first study of prolonged intravenous infusion of BAL101553. BAL101553 will be administered as an intravenous infusion over 48 hours, to adults with advanced or recurrent solid tumors or recurrent glioblastoma who have failed standard therapy, or for whom no effective standard therapy is available.

The primary goal of the study is to find the highest dose of BAL101553 that can safely be given to humans and to assess what side effects occur. The study will start by treating patients with a low dose. Once it has been shown that this low dose is well tolerated, new patients will be treated at higher dose levels ("dose escalation"). Once the highest, well tolerated dose is identified, 20 new patients with platinum-resistant/refractory ovarian cancer and 20 new patients with recurrent glioblastoma will be treated at that dose (this part is called "dose expansion") to further assess the tolerability and potential anticancer activity of oral BAL101553. The study will also measure pharmacokinetics, pharmacodynamic effects and assess biomarkers. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02895360
Study type Interventional
Source Basilea Pharmaceutica
Contact Thomas Kaindl, MD
Phone +41 61 567 1505
Email thomas.kaindl@basilea.com
Status Recruiting
Phase Phase 1/Phase 2
Start date August 2016
Completion date September 2019

See also
  Status Clinical Trial Phase
Recruiting NCT01443468 - Clinical and Genetic Studies of Li-Fraumeni Syndrome
Completed NCT01938846 - BI 860585 Dose Escalation Single Agent and in Combination With Exemestane or With Paclitaxel in Patients With Various Advanced and/or Metastatic Solid Tumors Phase 1
Not yet recruiting NCT03648372 - A Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of TAK-981 in Adult Participants With Metastatic Solid Tumors or Lymphomas. Phase 1
Completed NCT01938638 - Open Label Phase I Dose Escalation Study With BAY1143572 in Patients With Advanced Cancer Phase 1
Recruiting NCT02292641 - The Beyond TME Trial N/A
Terminated NCT00954512 - Study of Robatumumab (SCH 717454, MK-7454) in Combination With Different Treatment Regimens in Participants With Advanced Solid Tumors (P04722, MK-7454-004) Phase 1/Phase 2
Completed NCT01222728 - Using Positron Emission Tomography to Predict Intracranial Tumor Growth in Neurofibromatosis Type II Patients
Not yet recruiting NCT03210428 - Quantitative MR Imaging in Locally Advanced Cervical Cancer N/A
Recruiting NCT02909348 - Immunophenotyping of Melanoma Patients on Treatment With Pembrolizumab N/A
Recruiting NCT02926768 - Phase I/II Study of CK-101 in NSCLC Patients and Other Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT03190811 - Anti-PD-1 Alone or Combined With Autologous DC-CIK Cell Therapy in Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT02859857 - Phase 1 Study of BXQ-350 in Adult Patients With Advanced Solid Tumors Phase 1
Not yet recruiting NCT02806557 - Profiling Neutrophil Counts in Patients on Chemotherapy N/A
Recruiting NCT02514512 - Lung Cancer Radiotherapy Using Realtime Dynamic Multileaf Collimator (MLC) Adaptation And Radiofrequency Tracking Phase 1
Recruiting NCT02636426 - Sorafenib Administered Using a High-dose, Pulsatile Regimen: a Phase I Exposure Escalation Study Phase 1
Completed NCT01911936 - A Phase I Study of LJM716 in Japanese Patients With Advanced Solid Tumors Phase 1
Completed NCT01915576 - Phase I Dose Escalation Study With an Allosteric AKT 1/2 Inhibitor in Patients Phase 1
Recruiting NCT01562626 - Phase I/II Study of APS001F With Flucytosine and Maltose in Solid Tumors Phase 1/Phase 2
Completed NCT01688557 - Trial on Innovative Technologies in Colonoscopy N/A
Terminated NCT01695733 - Response to Influenza Vaccine in Patients With Non-Hematologic Malignancies Receiving Chemotherapy Phase 1