Enzastaurin Versus Lomustine in Glioblastoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00295815
First received: February 22, 2006
Last updated: June 12, 2014
Last verified: June 2014

February 22, 2006
June 12, 2014
January 2006
August 2007   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
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).
Complete list of historical versions of study NCT00295815 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • To measure changes in patient's ability to care for themselves (this will be determined through a standard survey). [ Time Frame: over entire study ] [ Designated as safety issue: No ]
  • To measure changes from baseline and a neurologic exam. [ Time Frame: baseline, each cycle ] [ Designated as safety issue: Yes ]
  • To review all bad reactions reported by the patient and detected in blood tests. [ Time Frame: each cycle ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • To determine through blood tests how long the medication is in the patient's body. [ Time Frame: cycle 1, cycle 4 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To measure survival to see how the tumor responded to the therapy and how long the response lasted using MRI (a scanning technique).
  • To measure changes in patient's ability to care for themselves (this will be determined through a standard survey).
  • To measure changes from baseline and a neurologic exam.
  • To review all bad reactions reported by the patient and detected in blood tests.
  • To review the effect of the cancer on the patient's ability to care for themselves and on their general health status.
  • To determine through blood tests how long the medication is in the patient's body.
  • 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.
Not Provided
Not Provided
 
Enzastaurin Versus Lomustine in Glioblastoma
Randomized Phase 3 Open Label Study - Enzastaurin vs. Lomustine in Glioblastoma

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Glioblastoma
  • Drug: enzastaurin
    1125 mg loading dose then 500 mg, oral, daily, 6 week cycles until PD
    Other Name: LY317615
  • Drug: lomustine
    100-130 mg/m2, oral once, every 6 weeks until PD
  • Experimental: A
    Intervention: Drug: enzastaurin
  • Active Comparator: B
    Intervention: Drug: lomustine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
397
May 2014
August 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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.
  2. 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.
  3. Patients receiving medication for seizures must discontinue 14 days prior to enrolling.
  4. Cannot be on blood thinning medication at study enrollment.
  5. Cannot be on other medicines to prevent cancer at study enrollment.
  6. Patients are not allowed to enter the study if they have previously taken Enzastaurin, Lomustine and/or Bevacizumab.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom,   Australia,   Austria,   Belgium,   Canada,   France,   Germany,   India,   Italy,   Mexico,   Netherlands,   Poland,   Spain
 
NCT00295815
9817, H6Q-MC-JCBF
Yes
Eli Lilly and Company
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP