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GlioblastomaEarly Phase 1NCT02207010

A Phase 0 Study of AZD1775 in Recurrent GBM Patients

A Early Phase 1 study testing AZD1775 in people with Glioblastoma and GBM, run by St. Joseph's Hospital and Medical Center, Phoenix at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study would test how much of the new drug, AZD1775, is present in tumor, blood, and skin after one dose of the drug. The purpose of the study is not to treat the tumor, but to see if the drug actually gets into the tumor cells. This study does not replace routine cancer treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioblastoma, GBM
What is being tested?
AZD1775
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
Jul 2014to 25 Mar 2019
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with 1 prior resection of histologically-diagnosed de novo GBM
  • Patient must have MRI evidence of disease recurrence
  • Patients must have Eastern Cooperative Oncology Group (ECOG) performance status ≤2
  • Patients ≥ 18 years of age
  • Adequate hematologic, renal, and hepatic function
  • Patients must not have co-morbid condition(s) that, at the opinion of the investigator, prevent safe surgical treatment
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  • Patients must not have active infection or fever > 38.5°C
  • Patients must not be pregnant or nursing
  • Patients must have archival tumor tissue block available for research use
  • Ability to understand and the willingness to sign a written informed consent document.
  • Patient has voluntarily agreed to participate by giving written informed consent.

Who cannot join

  • Less than 18 years of age
  • Diagnosis of anything other than first-recurrence GBM
  • GBM tissue from first-resection not available
  • Previous treatment with AZD1775
  • Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Patient has known hypersensitivity to the components of potential study therapy or its analogs.
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  • Patient has had prescription or non-prescription drugs or other products known to be metabolized by cytochrome P450 3A4 (CYP3A4), or to inhibit or induce CYP3A4, which cannot be discontinued prior to Day 1 of dosing and withheld throughout the study until 2 weeks after the last dose of study medication (inhibitors generally for 5 half-lives). Medications of particular concern are the following inhibitors of CYP3A4: azole antifungals (ketoconazole itraconazole, fluconazole and voriconazole), macrolide antibiotics (erythromycin, clarithromycin), cimetidine, HIV protease inhibitors, nefazodone and the following inducers of CYP3A4: phenytoin, barbiturates and rifampicin. Substrates of CYP3A4 include statins (lovastatin, simvastatin), midazolam, terfenadine, astemizole, and cisapride. CYP3A4.
  • Patient has a history or current evidence of any condition, therapy, or lab abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate.
  • Patient has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Patient is, at the time of signing informed consent, a regular user (including "recreational use") of any illicit drugs or had a recent history (within the last year) of drug or alcohol abuse.
  • Patients expecting to reproduce within the projected duration of the study (estimated to be 1 year), and women who are pregnant or breastfeeding.
  • Patient is known to be suffering from Acquired Immune Deficiency Syndrome (AIDS).
  • Patient has known history of Hepatitis B or C.
  • Patient has symptomatic ascites or pleural effusion. A patient who is clinically stable following treatment for these conditions is eligible.
  • Patient has a clinical history suggestive of Li-Fraumeni Syndrome.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Barrow Neurological Institute at St. Joseph's Hospital Medical Center

    Phoenix, Arizona, 85013

Other trials in United States

About this study

Official title: A Phase 0 Study of AZD1775 in Preoperative Glioblastoma Multiforme (GBM) Patients Scheduled for Resection to Evaluate for Central Nervous System (CNS) Penetration

This study would test how much of the new drug, AZD1775, is present in tumor, blood, and skin after one dose of the drug.

The purpose of the study is not to treat the tumor, but to see if the drug actually gets into the tumor cells. This study does not replace routine cancer treatment.

Read the detailed description

Patients will be administered one dose of AZD1775 prior to surgical resection of their tumor. There will be 2 portions of this trial, referred to as Part 1 and Part 2. Part 1 will involve a dose escalation strategy where 3 separate doses (100, 200, and 400mg) will be evaluated. Each dose cohort will involve 4 patients. Surgery, with tissue harvest for determination of both tissue drug level and biomarker evaluation, will occur at 8 hrs post drug administration.

Part 2 will determine the potential tumor drug level and PD effects at various time intervals after drug administration of a single select drug dose. Currently, we are planning to use a dose (200 mg) that has been deemed safe when used in combination with cytotoxic therapy. However, if results from Part 1 suggest an alternate dose may be preferable, we will consider using that alternate dose in Part 2. Dosing will be followed by surgical resection at 2-4 hrs and at 22-26 hrs post dose.

Conditions
Glioblastoma, GBM
Being tested
AZD1775
Keywords
Glioblastoma, GBM, first recurrence
Medical subject headings
Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AZD1775Biological

    Also called Wee1 inhibitor, MK1775

    All patients receive a single dose of the oral study drug prior to surgery for resection of GBM.

Study groups in NCT02207010
Study groupRoleWhat they receive
AZD1775ExperimentalPatients will receive a single dose (either 100 mg, 200 mg or 400 mg) of AZD1775, an oral agent, prior to surgery for resection of GBM
Receives: Biological: AZD1775

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plasma concentration of AZD1775 following single dose of AZD1775

    Will be summarized using descriptive statistics

    Measured: at baseline, 2-4, 8-12, and 22-26 hours following single dose of AZD1775

  2. Intratumoral concentration of AZD1775

    Will be summarized using descriptive statistics

    Measured: up to day of surgery

Secondary outcomes (3)

  1. Degree of CDC2 (Tyr15) phosphorylation in tissue

    Will be summarized using descriptive statistics

    Measured: at baseline and up to 26 hours post dosing

  2. Number of GBM cells in M-phase of cell cycle (PH3)

    Will be summarized using descriptive statistics

    Measured: at baseline and up to 26 hours post dose AZD1775

  3. Presence of double-strand DNA damage (γH2AX).

    Will be summarized using descriptive statistics

    Measured: at baseline and up to 26 hours post dose AZD1775

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2014 (estimated)
  2. Study startJul 2014
  3. Primary completion31 Dec 2015
  4. Study completion25 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02207010
Sponsor's protocol ID
BBTRC 001
Status last verified
Dec 2020
First submitted
28 Jul 2014
Last updated
10 Dec 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Sanai N, Li J, Boerner J, Stark K, Wu J, Kim S, Derogatis A, Mehta S, Dhruv HD, Heilbrun LK, Berens ME, LoRusso PM. Phase 0 Trial of AZD1775 in First-Recurrence Glioblastoma Patients. Clin Cancer Res. 2018 Aug 15;24(16):3820-3828. doi: 10.1158/1078-0432.CCR-17-3348. Epub 2018 May 24.

    PubMed 29798906

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing AZD1775 in people with Glioblastoma and GBM, run by St. Joseph's Hospital and Medical Center, Phoenix at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma concentration of AZD1775 following single dose of AZD1775 (time frame: at baseline, 2-4, 8-12, and 22-26 hours following single dose of AZD1775). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02207010, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2020; AzTrials last refreshed its copy on 6 Nov 2026.

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