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Completed

NCT Number: NCT00295815

Enzastaurin Versus Lomustine in Glioblastoma

This protocol will test the activity of Enzastaurin vs. Lomustine in the treatment of recurrent brain cancer (specifically intracranial glioblastoma multiforme).

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Key information

Conditions

Glioblastoma Astrocytoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Liverpool, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient presents with histologically confirmed diagnosis of brain cancer (specifically glioblastoma multiforme).
  • Your cancer has returned following therapy.
  • Patient may have undergone prior surgery to remove cancer.
  • Patient must be able to care for self.

Exclusion criteria

  • Have a second type of cancer (except adequately treated basal cell carcinoma of the skin). Patient who has had another cancer in the past, must be free of cancer for more than 2 years.
  • Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of entry.
  • Patients receiving medication for seizures must discontinue 14 days prior to enrolling.
  • Cannot be on blood thinning medication at study enrollment.
  • Cannot be on other medicines to prevent cancer at study enrollment.
  • Patients are not allowed to enter the study if they have previously taken Enzastaurin, Lomustine and/or Bevacizumab.

Treatment and study plan

enzastaurin

Drug

1125 mg loading dose then 500 mg, oral, daily, 6 week cycles until PD

Other names: LY317615

lomustine

Drug

100-130 mg/m2, oral once, every 6 weeks until PD

Primary outcomes

  1. The primary objective is to compare Enzastaurin versus Lomustine in patients who for the second time have brain cancer (specifically intracranial glioblastoma) to see what effect the drugs have on keeping the disease from progressing (worsening).

    Time frame: baseline to measured progressive disease (PD)

Secondary outcomes

  1. To measure survival to see how the tumor responded to the therapy and how long the response lasted using MRI (a scanning technique).

    Time frame: time of response to progressive disease

  2. To measure changes in patient's ability to care for themselves (this will be determined through a standard survey).

    Time frame: over entire study

  3. To measure changes from baseline and a neurologic exam.

    Time frame: baseline, each cycle

  4. To review all bad reactions reported by the patient and detected in blood tests.

    Time frame: each cycle

  5. To review the effect of the cancer on the patient's ability to care for themselves and on their general health status.

    Time frame: over entire study

  6. To determine through blood tests how long the medication is in the patient's body.

    Time frame: cycle 1, cycle 4

  7. To review through testing of tumor and blood samples to see if there are reasons why some patients responded to the drugs better than other patients.

    Time frame: baseline, cycle 2, end of study

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Randomized Phase 3 Open Label Study - Enzastaurin vs. Lomustine in Glioblastoma

Important dates

Study start
2006
Primary completion
2007
Study completion
2014
First posted
Feb 24, 2006
Registry last updated
Sep 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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