Enzastaurin Before and Concomitant With Radiation, Followed by Enzastaurin in Patients With Newly Diagnosed Glioblastoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00509821
First received: July 30, 2007
Last updated: January 31, 2014
Last verified: January 2014

July 30, 2007
January 31, 2014
October 2007
February 2010   (final data collection date for primary outcome measure)
Progression free survival rate 6 months after surgery. [ Time Frame: After 6 months ] [ Designated as safety issue: No ]
Progression free survival rate 6 months after surgery. [ Time Frame: After 6 months ]
Complete list of historical versions of study NCT00509821 on ClinicalTrials.gov Archive Site
  • Survival rate at 1 and 2 years after surgery [ Time Frame: 1 and 2 year ] [ Designated as safety issue: No ]
  • Response rate [ Time Frame: baseline to progressive disease ] [ Designated as safety issue: No ]
  • Survival rate at 1 and 2 years after surgery [ Time Frame: 1 and 2 year ]
  • Response rate
Not Provided
Not Provided
 
Enzastaurin Before and Concomitant With Radiation, Followed by Enzastaurin in Patients With Newly Diagnosed Glioblastoma
Enzastaurin Before and Concomitant With Radiation Therapy, Followed by Enzastaurin Maintenance Therapy in Patients With Newly Diagnosed Glioblastoma Without Methylation of the Promoter Gene of MGMT Enzyme - a Phase II Study

The purpose of the protocol is to induce a novel radiochemotherapy with enzastaurin as first-line treatment regimen in glioblastoma: Patients with active, unmethylated MGMT promoter will be treated with enzastaurin before, concomitant, and after radiotherapy to determine safety and PFS at 6 months (PFS-6) in phase II.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Glioblastoma Multiforme
  • Drug: enzastaurin

    Safety Run in Regimen 1: 1125 mg loading dose D(-)7 then 500 mg QD, oral, daily until disease progression

    Regimen 2: 1125 mg loading dose D(-)7 then 250 mg BID, oral, daily until disease progression

    Other Name: LY317615
  • Radiation: radiation
    Involved-field radiotherapy will be administered D1 after 7 day lead in enzastaurin treatment at a dose of 54 to 60 Gy, given in individual doses of 1.8 to 2 Gy 5 days a week for 6 weeks
Experimental: A
Enzastaurin before and concomitant with radiotherapy followed by Enzastaurin maintenance therapy
Interventions:
  • Drug: enzastaurin
  • Radiation: radiation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
March 2015
February 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Present with newly diagnosed histologically proven supratentorial GBM.
  • Demonstration of an unmethylated MGMT-promotor
  • Patients must sign an informed consent document. Patients must be at least 18 years of age.
  • Estimated life expectancy of at least 12 weeks
  • Tumor tissue specimens (paraffin-embedded and/or frozen) from the GBM surgery or biopsy must be available for central pathology review and exploratory analysis of PKC-beta targets (for example, GSK3beta).
  • Disease evaluated by Gd-MRI (magnetic resonance imaging) within 72 hours postoperatively
  • Interval of greater than or equal to 2 and less than or equal to 4 weeks since surgery or biopsy
  • ECOG Performance Status of less than or equal to 2
  • Adequate organ function including the following:
  • adequate bone marrow reserve: white blood cell (WBC) count greater than or equal to 3.0 X 109/L, absolute neutrophil count (ANC) greater than or equal to 1.5 X 109/L, platelet count greater than or equal to 75.0 X 109/L, and hemoglobin greater than or equal to 10.0 g/dL (greater than or equal to 6.2 mmol/L).
  • Hepatic: bilirubin less than or equal to 1.5 times the upper limit of normal (X ULN), alkaline phosphatase (ALP), aspartate transaminase (AST), and alanine transaminase (ALT) less than or equal to 2.5 X ULN, or less than or equal to 5 X ULN with liver metastases
  • Renal: serum creatinine less than or equal to 1.5 X ULN
  • Blood clotting: prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits
  • Patients must discontinue use of enzyme-inducing antiepileptic drugs (EIAEDs) greater than or equal to 14 days prior to study enrollment. The investigator may prescribe non-EIAEDs. Patients who must begin EIAED therapy while on study will be allowed to remain on study.
  • Clinically normal cardiac function without history of ischemic heart disease in the past 6 months and normal 12-lead electrocardiogram (ECG); no history of stroke

Exclusion Criteria:

  • Have a prior malignancy (other than glioblastoma, or adequately treated carcinoma in situ of the cervix, or nonmelanoma skin cancer), unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence
  • Unable to undergo Gd MRI
  • Prior chemotherapy within the last 5 years
  • Prior chemotherapy for a brain tumor
  • Prior radiotherapy of the head
  • Are unable to discontinue use of carbamazepine, phenobarbital, and phenytoin
  • History of coagulation disorder associated with bleeding, or recurrent thrombotic events
  • Are receiving concurrent administration of anticoagulant therapy
  • Placement of Gliadel® wafer at surgery
  • Have a serious concomitant systemic disorder (for example, active infection including HIV, or cardiac disease) - patients who are pregnant, anticipate becoming pregnant within 6 months after study participation, or are currently breast-feeding
  • Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00509821
11491, H6Q-MC-S039
No
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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
January 2014

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