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ATR Kinase Inhibitor

Adavosertib + Radiation + Temozolomide for Glioblastoma

Phase 1

Waitlist Available

Led By Eudocia Q Lee

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have a tumor tissue form indicating availability of archived tissue from initial resection at diagnosis of glioblastoma completed and signed by a pathologist

Patients must have a Karnofsky performance status >= 60%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

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.

Who is the study for?

This trial is for adults with new or recurrent glioblastoma who can provide tissue samples, have a decent performance status (able to care for themselves), normal organ and marrow function, no severe allergies to similar drugs, and not on certain medications. Women must test negative for pregnancy and agree to birth control.Check my eligibility

What is being tested?

The trial tests the combination of adavosertib with radiation therapy and temozolomide chemotherapy in patients with glioblastoma. It aims to find the best dose of adavosertib that's effective when used alongside standard treatments without causing severe side effects.See study design

What are the potential side effects?

Potential side effects include issues related to cell growth inhibition which may affect various organs, typical chemotherapy-related symptoms like nausea, fatigue, hair loss, blood disorders as well as risks associated with radiation such as skin irritation at the treatment site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a signed form proving I have tissue from my initial brain tumor surgery.

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I can care for myself but may need occasional help.

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I have no other cancers except possibly treated skin, cervical, breast, or bladder cancer.

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I can swallow pills without any issues.

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I have been diagnosed with glioblastoma.

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My glioblastoma has returned or worsened after radiation and possibly chemotherapy.

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I am scheduled for a surgery that my doctors say I need.

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My kidney function is within the normal range.

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I am not pregnant and agree to use two forms of birth control or abstain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

Incidence of toxicities

Maximum tolerated dose of adavosertib with 6 weeks of radiotherapy and temozolomide (Arm I)

Temozolomide

Secondary outcome measures

Overall survival

Progression-free survival

Other outcome measures

Apoptosis (cleaved caspase 3) levels

Genotyping data

Intratumoral adavosertib concentration

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (adavosertib, temozolomide)Experimental Treatment2 Interventions

Patients receive adavosertib PO QD on days 1, 3, and 5 or 1-5 weekly, and temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (adavosertib, temozolomide, radiation)Experimental Treatment3 Interventions

INITIATION CYCLE: Patients receive adavosertib PO on days 1, 3, and 5 or 1-5 weekly and temozolomide PO QD for 6 weeks. Patients also undergo concurrent radiation therapy 5 days per week for 6 weeks. MAINTENANCE CYCLES: Beginning in week 10, patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Temozolomide

2010

Completed Phase 3

~1930

Adavosertib

2015

Completed Phase 2

~570

Radiation Therapy

2017

Completed Phase 3

~7250

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,079 Total Patients Enrolled

322 Trials studying Glioblastoma

23,041 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

Media Library

Adavosertib (ATR Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01849146 — Phase 1

Glioblastoma Research Study Groups: Arm II (adavosertib, temozolomide), Arm I (adavosertib, temozolomide, radiation)

Glioblastoma Clinical Trial 2023: Adavosertib Highlights & Side Effects. Trial Name: NCT01849146 — Phase 1

Adavosertib (ATR Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01849146 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Adavosertib drug been endorsed by the Food and Drug Administration?

"Our assessment of Adavosertib's safety is a 1, as this trial is in Phase 1 and has limited evidence to back up its efficacy and security."

Answered by AI

How many individuals are affiliated with the research protocol?

"This medical trial is no longer seeking participants. Inaugurated on 8/19/2013 and most recently updated 9/20/202, this study has concluded its recruitment process. If you are searching for other clinical trials related to glioblastoma, 1391 studies permit patient enrollment at present; meanwhile 222 biomedical investigations accept volunteers with Adavosertib as well."

Answered by AI

Are there any open slots for participation in this research project?

"Unfortunately, this particular trial is not accepting any more candidates. It was first posted in August 2013 and last edited on September 2022. If you're still seeking a clinical trial to participate in, there are 1,391 trials for glioblastoma and 222 studies recruiting patients taking Adavosertib."

Answered by AI

How many locations are currently conducting this trial?

"The medical study is accepting enrollees at Johns Hopkins University/Sidney Kimmel Cancer Center in Baltimore, Dana-Farber Cancer Institute in Boston, and Cleveland Clinic Foundation in Ohio. Additionally, there are 12 additional sites where participation is open to the public."

Answered by AI

What conditions are amenable to treatment with Adavosertib?

"Nitrosourea therapy is often treated with Adavosertib, an effective solution for a variety of afflictions including advance directives, refractory advanced mycosis fungoides and neuroblastoma."

Answered by AI

Can you elucidate on the other investigations conducted using Adavosertib?

"Currently, 222 medical trials are underway in regards to Adavosertib. Of these studies, 23 have progressed to the third phase of clinical testing. The majority of research is happening in Seoul and Songpa; however there are 6451 other sites that contribute data for this medication's evaluation."

Answered by AI

Does this research endeavor bring a new perspective to the field?

"Since its first trial in 2002, which was funded by Schering-Plough and involved 60 participants, Adavosertib has become a validated Phase 2 drug. Currently, the medication is being trialled across 1170 cities located in 39 nations; with 222 trials active worldwide."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Adavosertib, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed or Recurrent Glioblastoma

2013. "Adavosertib, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed or Recurrent Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01849146.

All > Recurrent Glioblastoma > Glioblastoma Multiforme