Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02630030 : Phase 0 Analysis of Ixazomib (MLN9708) in Patients With Glioblastoma
PhaseEarly Phase 1
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- 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be withdrawn by the patient at any time without prejudice to future medical care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)

- 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

Exclusion Criteria:

- 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

- 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
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02630030      |      Link to official Clinicaltrials.gov listing
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