GlioblastomaEarly Phase 1NCT02630030
Phase 0 Analysis of Ixazomib (MLN9708) in Patients With Glioblastoma
A Early Phase 1 study testing Ixazomib in people with Glioblastoma, run by Emory University at 1 site in United States.
Trial summary
This phase 0 trial studies ixazomib citrate in treating patients with glioblastoma that has spread or returned after period of improvement who are planning to undergo surgery. When given by mouth, ixazomib may be able to reach tumor cells in the brain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Ixazomib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2016to 3 Sep 2020
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
- Female patients who:
- Are postmenopausal for at least 1 year before the screening visit, OR
- Are surgically sterile, OR
- If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR
- Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
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- Male patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:
- Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR
- Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
- Patients must have a previous diagnosis of a recurrent or progressive glioblastoma for which surgical resection is now indicated
- Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status 0, 1, or 2 or (Karnofsky performance status of 60 or above)
- Absolute neutrophil count (ANC) ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³; platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment
- Hemoglobin > 9 g/dL
- Total bilirubin ≤ 1.5 x the upper limit of the normal range (ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN for the lab utilized
- Creatinine ≤ 1.5 mg/dL
- Calculated creatinine clearance ≥ 30 mL/min
Who cannot join
- Female patients who are lactating or have a positive serum pregnancy test during the screening period
- Failure to have fully recovered (ie, ≤ grade 1 toxicity) from the reversible effects of prior chemotherapy
- Major surgery, including craniotomy, within 14 days before enrollment
- Radiotherapy of brain tumor within 3 months before enrollment
- Infection requiring systemic antibiotic therapy or other serious infection within 14 days before study enrollment
- Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months
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- Systemic treatment, within 14 days before the first dose of ixazomib, with strong inhibitors of cytochrome P450, family 1, subfamily A, polypeptide 2 (CYP1A2) (fluvoxamine, enoxacin, ciprofloxacin), strong inhibitors of cytochrome P450, family 3, subfamily A (CYP3A) (clarithromycin, telithromycin, itraconazole, voriconazole, ketoconazole, nefazodone, posaconazole) or strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of ginkgo biloba or St. John's wort
- Ongoing or active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive
- Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol
- Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent
- Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing
- Diagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease; patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection
- Patient has ≥ grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
- Participation in other clinical trials utilizing other therapeutic investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial
- Patients that have previously been treated with ixazomib, or participated in a study with ixazomib whether treated with ixazomib or not
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University/Winship Cancer Institute
Atlanta, Georgia, 30322
About this study
This phase 0 trial studies ixazomib citrate in treating patients with glioblastoma that has spread or returned after period of improvement who are planning to undergo surgery. When given by mouth, ixazomib may be able to reach tumor cells in the brain. Studying samples of tissue, blood, and plasma in the laboratory from patients receiving ixazomib may help doctors learn more about the effects of ixazomib on the cells. It may also help doctors understand how well patients will respond to treatment.
Read the detailed description
PRIMARY OBJECTIVES:
- Measurement of tissue concentration of ixazomib (ixazomib citrate) in a glioblastoma after preoperative administration.
II. Measurement of blood and plasma concentration of ixazomib during surgical sampling after preoperative administration.
SECONDARY OBJECTIVE:
- Assessment of the safety of ixazomib after single dose administration in glioblastoma patients undergoing surgery for tissue concentration assessment.
OUTLINE:
Patients receive ixazomib orally (PO) 3 hours before surgery.
After completion of study, patients are followed up for 30 days and then periodically thereafter.
- Conditions
- Glioblastoma
- Being tested
- Ixazomib
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IxazomibDrug
Also called MLN9708
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Ixazomib | Experimental | Patients receive ixazomib PO 3 hours before surgery. Receives: Drug: Ixazomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Ixazomib in Tumor Tissue
The relationship between patient's demographic, tumor and drug concentration results will be assessed with Pearson's correlation coefficient and tested with Wald's test. In addition, the mean and standard error of the concentrations will be estimated using a random-effects model to account for the within-patient correlation of the tumor biopsy samples. Given the limited number of observations, a relatively simple covariance matrix (e.g. compound symmetry) will be assumed.
Measured: At time of surgery, approximately 3 hours
Number of Patients With Safety and Tolerability of Ixazomib
Safety was assessed with routine postoperative laboratory, vital sign, neurologic exam, and imaging studies through the day of surgery to staple or suture removal. This data was collected and any adverse events graded and their relationship to ixazomib administration determined.
Measured: At the time of surgery, approximately 3 hours
Secondary outcomes (1)
Number of Participants With Treatment-Emergent Adverse Events
The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) was used to stratify any adverse patient response to ixazomib. There were no clinically relevant adverse events as a result of ixazomib administration.
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study start24 Mar 2016
- Primary completion1 Jul 2018
- Study completion3 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda
- Responsible party
- Principal investigator, Jeffrey James Olson, Emory University
- Investigators
- Jeffrey J. Olson, MD, Principal investigator, Emory University/Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02630030
- Sponsor's protocol ID
- IRB00083003
- Other IDs
- NCI-2015-01682, X16071, Winship3017-15
- Status last verified
- Feb 2021
- First submitted
- 6 Dec 2015
- Last updated
- 26 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Quillin J, Patel R, Herzberg E, Alton D, Bikzhanova G, Geisler L, Olson J. A phase 0 analysis of ixazomib in patients with glioblastoma. Mol Clin Oncol. 2020 Nov;13(5):43. doi: 10.3892/mco.2020.2114. Epub 2020 Aug 13.
PubMed 32874573
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 0 Analysis of Ixazomib (MLN9708) in Patients With Glioblastoma
- ClinicalTrials.gov ID
- NCT02630030
- Acronym / sponsor ID
- IRB00083003
- Conditions
- Glioblastoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Takeda
- Study start
- 24 Mar 2016 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 3 Sep 2020 (actual)
- First posted
- 15 Dec 2015 (estimated)
- Results
- Posted 26 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase 0 trial studies ixazomib citrate in treating patients with glioblastoma that has spread or returned after period of improvement who are planning to undergo surgery. When given by mouth, ixazomib may be able to reach tumor cells in the brain. Studying samples of tissue, blood, and plasma in the laboratory from patients receiving ixazomib may help doctors learn more about the effects of ixazomib on the cells. It may also help doctors understand how well patients will respond to treatment.
Detailed description
PRIMARY OBJECTIVES:
- Measurement of tissue concentration of ixazomib (ixazomib citrate) in a glioblastoma after preoperative administration.
II. Measurement of blood and plasma concentration of ixazomib during surgical sampling after preoperative administration.
SECONDARY OBJECTIVE:
- Assessment of the safety of ixazomib after single dose administration in glioblastoma patients undergoing surgery for tissue concentration assessment.
OUTLINE:
Patients receive ixazomib orally (PO) 3 hours before surgery.
After completion of study, patients are followed up for 30 days and then periodically thereafter.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ixazomib | Experimental | Drug: IxazomibPatients receive ixazomib PO 3 hours before surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
- Female patients who:
- Male patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:
- Patients must have a previous diagnosis of a recurrent or progressive glioblastoma for which surgical resection is now indicated
- Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status 0, 1, or 2 or (Karnofsky performance status of 60 or above)
Key exclusion criteria (15 listed)
- Female patients who are lactating or have a positive serum pregnancy test during the screening period
- Failure to have fully recovered (ie, ≤ grade 1 toxicity) from the reversible effects of prior chemotherapy
- Major surgery, including craniotomy, within 14 days before enrollment
- Radiotherapy of brain tumor within 3 months before enrollment
- Infection requiring systemic antibiotic therapy or other serious infection within 14 days before study enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IxazomibAlso: MLN9708Given PO | Drug | Ixazomib |
Primary outcome
Concentration of Ixazomib in Tumor Tissue
Time frame: At time of surgery, approximately 3 hours
The relationship between patient's demographic, tumor and drug concentration results will be assessed with Pearson's correlation coefficient and tested with Wald's test. In addition, the mean and standard error of the concentrations will be estimated using a random-effects model to account for the within-patient correlation of the tumor biopsy samples. Given the limited number of observations, a relatively simple covariance matrix (e.g. compound symmetry) will be assumed.
Number of Patients With Safety and Tolerability of Ixazomib
Time frame: At the time of surgery, approximately 3 hours
Safety was assessed with routine postoperative laboratory, vital sign, neurologic exam, and imaging studies through the day of surgery to staple or suture removal. This data was collected and any adverse events graded and their relationship to ixazomib administration determined.
1 secondary outcome
Number of Participants With Treatment-Emergent Adverse Events
Time frame: Up to 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32874573Quillin J, Patel R, Herzberg E, Alton D, Bikzhanova G, Geisler L, Olson J. A phase 0 analysis of ixazomib in patients with glioblastoma. Mol Clin Oncol. 2020 Nov;13(5):43. doi: 10.3892/mco.2020.2114. Epub 2020 Aug 13.
- Molecular and Clinical Oncology PublicationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey J. Olson, MD principal investigator
Emory University/Winship Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ixazomib in people with Glioblastoma, run by Emory University 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 18 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 26 Mar 2021. 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?
Yes. Results are posted in the registry (first posted 26 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Concentration of Ixazomib in Tumor Tissue (time frame: At time of surgery, approximately 3 hours). 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 NCT02630030, 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 26 Mar 2021.