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NCT02186509 · ClinicalTrials.gov registry record · Phase 1

Alisertib and Fractionated Stereotactic Radiosurgery in Treating Patients With Recurrent High Grade Gliomas

A Phase 1 study of Adult Glioblastoma and Adult Giant Cell Glioblastoma, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.

Completed
Registry status
Phase 1
Development phase
17
Enrollment target
1
Study location

NCT02186509 is a Phase 1 study of Adult Glioblastoma and Adult Giant Cell Glioblastoma that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. The registered enrollment target is 17 participants, below the 42-participant average among 14 other Adult Glioblastoma trials with a reported enrollment target (60% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02186509, a Phase 1 study of Adult Glioblastoma and Adult Giant Cell Glioblastoma, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.

COMPLETED
Registry status
Phase 1
Development phase
17 participants
Enrollment target
1
Study location

Study Summary

This phase I trial studies the side effects and best dose of alisertib when combined with fractionated stereotactic radiosurgery in treating patients with high-grade gliomas that have returned after previous treatment with radiation therapy (recurrent). Alisertib may stop the growth of tumor cells by blocking an enzyme needed for the cells to divide. Radiation therapy uses high energy x rays to kill tumor cells. Stereotactic radiosurgery uses special positioning equipment to send a single high dose of radiation directly to the tumor and cause less damage to normal tissue. Delivering stereotactic radiosurgery over multiple doses (fractionation) may cause more damage to tumor tissue than normal tissue while maintaining the advantage of its accuracy.

Interventions

  • DRUG Alisertib
  • RADIATION Stereotactic radiosurgery
  • PROCEDURE Quality-of-life assessment
  • RADIATION Hyperfractionated radiation therapy

Study Locations (1)

Pennsylvania

  • Sidney Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2015-01-30
Est. Completion 2018-12-31
Phase Phase 1

What the Registry Record Tells You About NCT02186509

The ClinicalTrials.gov registry entry for NCT02186509 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 42-participant average among 14 other Adult Glioblastoma trials with a reported enrollment target (60% lower). The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Adult Glioblastoma appearing as the primary indexed condition, and to 4 interventions - of which Alisertib is the first listed.

NCT02186509 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT02186509 about?

NCT02186509 is a clinical study titled "Alisertib and Fractionated Stereotactic Radiosurgery in Treating Patients With Recurrent High Grade Gliomas". This phase I trial studies the side effects and best dose of alisertib when combined with fractionated stereotactic radiosurgery in treating patients with high-grade gliomas that have returned after previous treatment with radiation therapy (recurrent). Alisertib may stop the growth of tumor cells b...

What is the current status of trial NCT02186509?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2015-01-30. Estimated completion is 2018-12-31.

What conditions does trial NCT02186509 study?

This clinical trial studies the following conditions: Adult Glioblastoma, Adult Giant Cell Glioblastoma, Adult Gliosarcoma, Adult Anaplastic Astrocytoma, Adult Anaplastic Oligodendroglioma.

What interventions are being tested in trial NCT02186509?

The interventions under investigation include: Alisertib (DRUG), Stereotactic radiosurgery (RADIATION), Quality-of-life assessment (PROCEDURE), Hyperfractionated radiation therapy (RADIATION).

Who is sponsoring clinical trial NCT02186509?

This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02186509 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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