Enzastaurin Versus Lomustine in Glioblastoma - Full Text View

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00295815

Purpose

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

Condition	Intervention	Phase
Glioblastoma	Drug: enzastaurin Drug: lomustine	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Randomized Phase 3 Open Label Study - Enzastaurin vs. Lomustine in Glioblastoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Lomustine Enzastaurin

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	397
Study Start Date:	March 2006
Estimated Study Completion Date:	April 2012
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A	Drug: enzastaurin 1125 mg loading dose then 500 mg, oral, daily, 6 week cycles until PD Other Name: LY317615
Active Comparator: B	Drug: lomustine 100-130 mg/m2, oral once, every 6 weeks until PD

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00295815

Show 98 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

Investigators

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

More Information

No publications provided

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00295815 History of Changes
Other Study ID Numbers:	9817, H6Q-MC-JCBF
Study First Received:	February 22, 2006
Last Updated:	March 11, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

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

Neoplasms, Nerve Tissue
Lomustine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012