Clinical Trial Details
Braintumor Website

[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.]

NCT03423628 : A Study to Assess the Safety and Tolerability of AZD1390 Given With Radiation Therapy in Patients With Brain Cancer
PhasePhase 1
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- Provision of formalin-fixed paraffin embedded tissue sample from primary or metastatic
disease

- Karnofsky Performance Score of =60.

- Additional Inclusion Criteria Specific for Arm A:

- Histologically proven diagnosis of GBM.

- A radiological diagnosis of recurrent/relapsed or progressive disease according
to RANO criteria.

- Completion of first-line radiation at least 6 months prior to study entry.

- Patients with tumor-induced seizures must be well controlled on a stable
anti-epileptic treatment

- Willing to receive anti-epileptic prophylaxis for the duration of study drug
administration.

- Additional Inclusion Criteria Specific for Arm B:

- Histologically proven diagnosis of solid tumor malignancy and Magnetic Resonance
(MR) imaging documenting brain lesions.

- Not eligible for Stereotactic Radiosurgery (SRS) treatment of brain tumor.

- Patient has not received any previous brain RT.

- Non-central nervous system (CNS) malignant disease must be sufficiently
controlled so that patient can be without additional systemic therapy for
approximately 2 months

- Not received radiation to the lung fields within the past 8 weeks.

- No history of seizures related to the brain metastases or LMD.

- Additional Inclusion Criteria Specific for Arm C:

- Histologically proven primary diagnosis of GBM with unmethylated
O6-methylguanine-DNA methyltransferase (MGMT).

- Determination of MGMT promoter status by methylation-specific polymerase chain
reaction (PCR) per local institutional guidelines is required to assess
eligibility for this Arm.

- Patients will have to undergo mutational testing for Isocitrate dehydrogenase 1
(IDH1) on a tumor specimen before entering study. Patients are eligible for Arm C
regardless of their IDH1 mutational status.

- No history of uncontrolled seizures after surgery for primary GBM (despite
adequate antiepileptic therapy) or with need for concurrent administration of
more than 2 antiepileptic drugs.

- Willing to receive anti-epileptic prophylaxis for the duration of study drug
administration

Exclusion Criteria:

- Administration of chemotherapy or any investigational drug in the 28 days prior to
receiving the first dose of treatment.

- History of severe brain-injury or stroke.

- Patient not eligible for sequential MRI evaluations are not eligible for this study.

- History of epileptic disorder or any seizure history unrelated to tumor

- Treatment with Strong inhibitors or inducers of CYP3A4 within 2 weeks prior to
receiving study drug

- Concurrent therapy with other seizurogenic medications.

- Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation
pneumonitis which required steroid treatment, or any evidence of clinically active
ILD.

- Concurrent severe and/or uncontrolled medical condition (e.g., severe COPD).

- Prior treatment with pneumotoxic drugs within past year. If prior therapy in lifetime,
then excluded if history of pulmonary toxicities from administration.

- History or presence of myopathy or raised creatine kinase (CK) >5 x upper limit of
normal (ULN) on 2 occasions at screening.

- Cardiac dysfunction defined as: Myocardial infarction within six months of study
entry, NYHA (New York Heart Association) Class II/III/IV heart failure, unstable
angina, unstable cardiac arrhythmias

- Evidence of severe pulmonary infections, as judged by the investigator
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03423628      |      Link to official Clinicaltrials.gov listing
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