Study Summary
This trial is studying adavosertib given with radiation therapy and temozolomide to see how well it works compared to radiation therapy and temozolomide alone in treating patients with newly diagnosed or recurrent glioblastoma.
Eligible Conditions
- Glioblastoma
- Glioblastoma (GBM)
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 2 Secondary · Reporting Duration: Up to 2 years
Week 1
Temozolomide
Year 2
Overall survival
Year 2
Progression-free survival
Up to 2 years
Apoptosis (cleaved caspase 3) levels
Genotyping data
MGMT methylation status
P-gp expression level
P53 mutation status
Proliferation (Ki-67) expression levels
Wee1 expression level
pCDC2 expression levels
pRb (S807/811) expression levels
Up to 28 days
Temozolomide
Day 30
Incidence of toxicities
Up to 6 weeks
Maximum tolerated dose of adavosertib with 6 weeks of radiotherapy and temozolomide (Arm I)
Up to the day of surgery
Intratumoral adavosertib concentration
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Arm I (adavosertib, temozolomide, radiation)
1 of 2
Arm II (adavosertib, temozolomide)
1 of 2
Experimental Treatment
74 Total Participants · 2 Treatment Groups
Primary Treatment: Adavosertib · No Placebo Group · Phase 1
Arm I (adavosertib, temozolomide, radiation)Experimental Group · 3 Interventions: Adavosertib, Radiation Therapy, Temozolomide · Intervention Types: Drug, Radiation, Drug
Arm II (adavosertib, temozolomide)Experimental Group · 2 Interventions: Adavosertib, Temozolomide · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MK-1775
Not yet FDA approved
Radiation Therapy
2005
Completed Phase 3
~7010
Temozolomide
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,093 Previous Clinical Trials
41,143,246 Total Patients Enrolled
303 Trials studying Glioblastoma
22,441 Patients Enrolled for Glioblastoma
Eudocia Q LeePrincipal InvestigatorNational Cancer Institute (NCI)
2 Previous Clinical Trials
177 Total Patients Enrolled
2 Trials studying Glioblastoma
177 Patients Enrolled for Glioblastoma
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a PTT/APTT of < 1.5 x institutional upper limit of normal.
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Conditions
Cancer Related
Treatments