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|NCT02282917 : Exploratory Evaluation of AR-42 Histone Deacetylase Inhibitor in the Treatment of Vestibular Schwannoma and Meningioma|
|Phase||Early Phase 1|
|Ages||Min: 18 Years Max: N/A|
- Patients with vestibular schwannoma and/or meningioma diagnosed by MRI where surgical
resection has been selected as treatment.
- Patients diagnosed with NF2 must meet Manchester Criteria.
- Age > 18 years of age
- Prior biologic therapy, chemotherapy, surgery or radiation is permitted.
- At the time of screening, the patient must have normal organ and marrow function.
- Eastern Cooperative Oncology Group/World Health Organization (ECOG/WHO) performance
status of 0-1.
- Patients must be able to swallow capsules.
- Patients or their legal representatives must be able to read, understand and provide
informed consent to participate in the trial.
- Tumor type will be confirmed by a neuropathologist.
- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy
test with a sensitivity of at least 50 mIU/mL prior to starting AR-42.
- The patient must be willing to comply with fertility requirements
- Pregnant women are excluded from this study because the potential for teratogenic or
abortifacient effects of AR-42 are not known. Because there is an unknown but
potential risk for AEs in nursing infants secondary to treatment of the mother with
AR-42, breastfeeding should be discontinued if the mother is treated with AR-42.
- Pediatric patients are excluded from the phase 0 study as the effects of AR-42 are not
known on children and there is no potential direct benefit to them.
- Patients with malabsorption or any other condition that in the opinion of the
principal investigator could cause difficulty in absorption of drug.
- Patients requiring chronic corticosteroids (dose equivalent > 20mg prednisolone).
- Concurrent use of complementary or alternative medicines that in the opinion of the
principal investigator would confound the interpretation of toxicities and/or
antitumor activity of the study drug.
- Patients with a "currently active" second malignancy that, in the opinion of the
principal investigator, will interfere with patient participation, increase patient
risk, or confound data interpretation.
- Patients with a mean QTcB > 450 msec in males and > 470 msec in females.
- Patients with long QT syndrome.
- Patients who are being treated for an active infection.
- Patients receiving the following concomitant medications:
- Any other anti-neoplastic chemotherapy or biologic therapy during the study
- Concomitant radiotherapy
- Concomitant HDAC inhibitors (e.g. valproic acid) as class-specific adverse
reactions may be additive
- Use of granulocyte colony-stimulating factors including G-CSF, pegylated G-CSF or
GM-CSF should follow ASCO guidelines for patients receiving anti-cancer therapy.
- Drugs associated with QT/QTc prolongation (see Appendix A)
- Patients who are receiving concurrent anti-neoplastic therapy.
- Any other medical condition, including mental illness or substance abuse, deemed by
the principal investigator to likely interfere with a patient's ability to sign
informed consent, cooperate and participate in the study, or interfere with the
interpretation of the results.
- Patients with significant cardiovascular disease, including a myocardial infarction or
unstable angina within 6 months or unstable cardiac arrhythmias are not eligible for
- Known HIV infection, as their immunosuppressive conditions may complicate potential
pancytopenias seen with HDAC inhibitors and complicate evaluation of drug effect.
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02282917
| Link to official Clinicaltrials.gov listing