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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
Women of childbearing potential must have a negative serum pregnancy test prior to study entry and agree to use two birth control methods or abstinence
Patients must have a Karnofsky performance status >= 60%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group

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 am not pregnant and agree to use two forms of birth control or abstain.
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I can care for myself but may need occasional help.
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I can swallow pills without any issues.
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My glioblastoma has returned or worsened after radiation and possibly chemotherapy.
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My kidney function is within the normal range.
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I have no other cancers except possibly treated skin, cervical, breast, or bladder cancer.
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I have been diagnosed with glioblastoma.
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I am scheduled for a surgery that my doctors say I need.
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I have a signed form proving I have tissue from my initial brain tumor surgery.

Timeline

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,586 Previous Clinical Trials
41,242,125 Total Patients Enrolled
314 Trials studying Glioblastoma
22,710 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
~6 spots leftby Feb 2025