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Microtubule-Targeted Agent

Microtubule-Targeted Agent BAL101553 for Glioblastoma

Phase 1
Waitlist Available
Research Sponsored by Basilea Pharmaceutica
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up initial diagnosis to date of death - up to 2 years
Awards & highlights

Study Summary

This trial is studying the side effects and best dose of a drug given with radiation therapy for newly diagnosed glioblastoma.

Eligible Conditions
  • Glioblastoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~initial diagnosis to date of death - up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and initial diagnosis to date of death - up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose (MTD)
Secondary outcome measures
Area Under the Concentration-time Curve (AUC)
Maximum Plasma Concentration
Overall Survival
+3 more
Other outcome measures
Clearance and Volume
Half-life

Side effects data

From 2020 Phase 1 & 2 trial • 43 Patients • NCT02895360
75%
Decreased appetite
75%
Fatigue
50%
Nausea
50%
Constipation
50%
Hypokalaemia
50%
Abdominal pain
50%
Hallucination
50%
Insomnia
25%
Blood creatinine increased
25%
Neutrophil count decreased
25%
Platelet count decreased
25%
Ataxia
25%
Dysarthria
25%
Diarrhoea
25%
Vomiting
25%
Alopecia
25%
Rash
25%
Hyponatraemia
25%
Pyrexia
25%
Myalgia
25%
Oral herpes
25%
White blood cell count decreased
25%
Cough
25%
Epistaxis
25%
Bone pain
25%
Dehydration
25%
Cystitis
25%
Pain
25%
Hypotension
25%
Restlessness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1 - 90 mg/m² Cohort
Phase 1 - 70 mg/m² Cohort
Phase 1 - 30 mg/m² Cohort
Phase 1 - 45 mg/m² Cohort
Phase 2a - Recurrent Glioblastoma Cohort
Phase 2a - Ovarian Cancer Cohort

Trial Design

1Treatment groups
Experimental Treatment
Group I: Dose FindingExperimental Treatment4 Interventions
Fixed 3+3 dose escalation of BAL101553 (7 days per week), combined with RT days 1-5 for 6 weeks followed by 4 week rest.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2017
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

Basilea PharmaceuticaLead Sponsor
40 Previous Clinical Trials
9,045 Total Patients Enrolled
2 Trials studying Glioblastoma
114 Patients Enrolled for Glioblastoma
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsOTHER
557 Previous Clinical Trials
32,870 Total Patients Enrolled
31 Trials studying Glioblastoma
953 Patients Enrolled for Glioblastoma
Matthias Holdhoff, MDStudy ChairNational Cancer Institute (NCI)
1 Previous Clinical Trials
28 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Microtubule-Targeted Agent BAL101553 and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma
2017. "Microtubule-Targeted Agent BAL101553 and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03250299.
~4 spots leftby Apr 2025
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