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Protocol # 18-018

Status

Recruiting

Description

This study will test an investigational drug called AZD1390 in combination with radiation therapy for the treatment of brain tumors. This is the first time AZD1390 is being given to patients. This study will test safety, tolerability and PK (how the drug is absorbed, distributed and eliminated) of ascending doses of AZD1390 in combination with distinct regimens of radiation therapy

Condition

  • Recurrent Glioblastoma Multiforme
  • Primary Glioblastoma Multiforme
  • Brain Neoplasms, Malignant
  • Leptomeningeal Disease (LMD)

Interventions

  • Radiation Therapy
  • AZD1390

Phase

Phase 1

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Incidence of dose-limiting toxicities (DLTs)
  • Incidence of adverse events (AEs) and serious adverse events (SAEs)

Secondary Outcome:

  • Event free survival (EFS) for Arms A and C only
  • Objective response rate defined by RANO criteria for Arms A and C only
  • Objective response rate defined by RANO-BM criteria for Arm B only. **Arm B has now closed to recruitment**
  • Objective response rate defined by RECIST 1.1 criteria for Arm B only. **Arm B has now closed to recruitment**
  • Maximum Observed Plasma Concentration (Cmax) of AZD1390
  • Time to observed Cmax (Tmax) for AZD1390
  • Area under the plasma concentration-time curve (AUC) for AZD1390
  • Renal clearance (CLR) for AZD1390
  • Overall survival for Arms A and C only
  • Assessment of the food effect of AZD1390 at the MTD for Arm A (if conducted)
  • Assessment of the food effect of AZD1390 at the MTD for Arm A (if conducted)
  • Assessment of the food effect of AZD1390 at the MTD for Arm A (if conducted)

Enrollment

120

Study Start Date

April 2, 2018

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     130 Years
  • Healthy volunteers:     No

Sponsors

AstraZeneca

Source

AstraZeneca

Official title

A Phase I, Multicentre Study to Assess the Safety, Tolerability, and Pharmacokinetics of Ascending Doses of AZD1390 in Combination With Radiation Therapy in Patients With Glioblastoma Multiforme and Brain Metastases From Solid Tumors.

Clinicaltrials.gov Identifier

NCT03423628

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.