- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02490800
Phase 1/2a Study of Oral BAL101553 in Adult Patients With Solid Tumors or Glioblastoma or High-grade Glioma
An Open-label Phase 1/2a Study of Oral BAL101553 in Adult Patients With Advanced Solid Tumors and in Adult Patients With Recurrent or Progressive Glioblastoma or High-grade Glioma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is the first study of the oral formulation of BAL101553. BAL101553 will be administered once daily during each day of a 28-day treatment cycle in capsule form to adults with advanced or recurrent solid tumors or recurrent or progressive glioblastoma or high-grade glioma who have failed standard therapy, or for whom no effective standard therapy is available.
In Phase 1, the highest dose of BAL101553 was determined that can safely be given to adults with advanced or recurrent solid tumors, recurrent or progressive glioblastoma or high-grade glioma who have failed standard therapy, or for whom no effective standard therapy is available.
In Phase 2a, the tolerability and potential anticancer activity of oral BAL101553 will be assessed in patients with recurrent glioblastoma whose tumor tissue tests positive for end-binding protein 1 (EB1). The study will also measure pharmacokinetics, pharmacodynamic effects and assess biomarkers.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Leuven, Belgium, 3000
- UZ Leuven
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Frankfurt, Germany, 60528
- Klinikum der Goethe-Universität Frankfurt
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Heidelberg, Germany, 69120
- Universitätsklinikum Heidelberg
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Regensburg, Germany, 93053
- Universitätsklinikum Regensburg
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Tübingen, Germany, 72076
- Universitätsklinikum Tübingen
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Basel, Switzerland, 4031
- Universitatsspital Basel
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Bern, Switzerland, 3010
- INSELSPITAL Universitatsspital Bern
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St. Gallen, Switzerland, 9007
- Kantonsspital St. Gallen
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Zürich, Switzerland, 8091
- Universitatsspital Zurich
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Glasgow, United Kingdom, G12 0YN
- Beatson West of Scotland Cancer Centre
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London, United Kingdom, NW1 2BU
- University College London NHS Foundation Trust
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Newcastle upon Tyne, United Kingdom, NE7 7DN
- Sir Bobby Robson Cancer Trials Research Centre; Northern Centre for Cancer Care
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Sutton, United Kingdom, SM2 5PT
- Royal Marsden Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age ≥ 18 years
Patients who have in the
Phase 1 portion either of the following:
- a histologically- or cytologically confirmed advanced or recurrent solid tumor, who failed standard therapy, or for whom no effective standard therapy is available to them
- histologically-confirmed GBM or high-grade glioma, with progressive or recurrent disease after prior radiotherapy, with or without chemotherapy. This will also include patients with histologically-confirmed low-grade glioma who present with unequivocal evidence by imaging of transformation to high-grade glioma/GBM.
Phase 2 portion: Recurrent, histologically confirmed, glioblastoma with tumor tissue positive for EB1; eligible are patients with de novo glioblastoma after prior radical chemo-radiotherapy or secondary glioblastoma after prior chemotherapy or radiotherapy.
- Patients must have measurable disease.
- Life expectancy ≥ 12 weeks
- Acceptable organ and marrow function at baseline (protocol defined laboratory parameters)
- Patients with advanced solid tumors must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 and patients with recurrent or progressive glioblastoma must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Patients with advanced or recurrent 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 or progressive GBM or high-grade glioma 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.
- Patients who have had prior exposure to BAL1015533.
- Inability to swallow oral medication
- Increase in steroid dose in GBM or high-grade glioma patients within 5 days prior to first study-drug administration or requirement for > 6 mg/day dexamethasone or equivalent for symptom control.
- Patients with gastrointestinal disease or those who have had a procedure that is expected to interfere with the oral absorption or tolerance of BAL101553
- Symptomatic brain metastases or leptomeningeal disease, indicative of active disease, in patients with advanced or recurrent solid tumors.
- 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) ≥ 160 mmHg or diastolic blood pressure (DBP) ≥ 100 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Drug: BAL101553
Oral daily administration of BAL101553
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oral administration
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Phase 1: Maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of daily oral BAL101553 based on the number of participants with adverse effects as measure of tolerability at various dose levels
Time Frame: 28 day cycles
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28 day cycles
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Phase 2a: Best objective response according to RANO criteria
Time Frame: 28 day cycles
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28 day cycles
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and tolerability of daily oral BAL101553 based on the number of participants with adverse events at various dose levels
Time Frame: 28 day cycles
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Incidence of adverse events
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28 day cycles
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Safety and tolerability of daily oral BAL101553 based on the number of participants with safety laboratory changes versus baseline
Time Frame: 28 day cycles
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Incidence of clinically relevant laboratory changes
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28 day cycles
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Safety and tolerability of daily oral BAL101553 based on the number of participants with ECG changes versus baseline
Time Frame: 28 day cycles
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Incidence of clinically relevant ECG changes
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28 day cycles
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Cmax of BAL101553 and BAL27862
Time Frame: 28 day cycles
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Pharmacokinetic parameter "Peak Plasma Concentration" Cmax of BAL101553 and BAL27862
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28 day cycles
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Tmax of BAL101553 and BAL27862
Time Frame: 28 day cycles
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Pharmacokinetic parameter "Time to Peak Plasma Concentration" Tmax of BAL101553 and BAL27862
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28 day cycles
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AUC of BAL101553 and BAL27862
Time Frame: 28 day cycles
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Pharmacokinetic parameter "Area under the plasma concentration versus time curve" AUC of BAL101553 and BAL27862
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28 day cycles
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Half-life of BAL101553 and BAL27862
Time Frame: 28 day cycles
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Pharmacokinetic parameter Half-life of BAL101553 and BAL27862
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28 day cycles
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Anti-tumor activity of daily oral BAL101553 in cancer patients based on RECIST 1.1 -criteria (measurable disease of advanced or recurrent solid tumors).
Time Frame: 28 day cycles
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28 day cycles
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Anti-tumor activity of daily oral BAL101553 in cancer patients by contrast-enhanced MRI based on RANO criteria (recurrent or progressive GBM or high-grade glioma).
Time Frame: 28 day cycles
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28 day cycles
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Thomas Kaindl, MD, Basilea Pharmaceutica International Ltd
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDI-CS-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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