Clinical Trial: Phase 1/2 Study in Newly Diagnosed Glioblastoma Multiforme (GBM) and Gliosarcoma (GS) Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase 1/2 Study of Enzastaurin Plus Temozolomide During and Following Radiation Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma

Brief Summary:

There will be 2 phases in this study. Patients will either be enrolled to the first phase or to the second phase, depending upon when they enroll into the study.

The first phase of this study is done to evaluate the safety of enzastaurin in patients. This is done by gradually increasing the dose of the drug in small groups of patients and watching closely for side effects.

In the second phase of the study, the dose determined to be safe will be used with temozolomide during and following radiation therapy to see if the combination can help patients with brain tumors live longer.


Detailed Summary:
Sponsor: Eli Lilly and Company

Current Primary Outcome:

  • Phase 1 - To determine the maximum tolerated dose (MTD) of enzastaurin in patients with newly diagnosed GBM or GS [ Time Frame: until MTD can be deteremined ]
  • Phase 2 - To determine the efficacy of enzastaurin in combination with radiation therapy and temozolomide in patients with newly diagnosed GBM or GS as measured by overall survival (OS) [ Time Frame: baseline to death from any cause ]


Original Primary Outcome:

  • Phase 1
  • To determine the maximum tolerated dose of enzastaurin in patients with newly diagnosed GBM or GS
  • Phase 2
  • To determine the efficacy of enzastaurin in combination with radiation therapy and temozolomide in patients with newly diagnosed GBM or GS as measured by overall survival (OS)


Current Secondary Outcome:

  • Phase 1 - To characterize the safety of enzastaurin when combined with temozolomide and radiation therapy in this setting [ Time Frame: every cycle ]
  • Phase 1 - To characterize the pharmacokinetics of enzastaurin when administered in combination with temozolomide and radiation therapy [ Time Frame: cycle 1, cycle 2 ]
  • Phase 1 - To assess biomarkers relevant to enzastaurin and disease state, and their correlation to clinical outcome [ Time Frame: baseline, cycle 2, end of study ]
  • Phase 1 - To assess for evidence of antitumor activity in this patient population [ Time Frame: baseline, following radiation, every other cycle ]
  • Phase 2 - To evaluate progression free survival (PFS) [ Time Frame: baseline to measured progressive disease ]
  • Phase 2 - To evaluate the safety profile of enzastaurin in combination with temozolomide and radiation therapy in this patient population [ Time Frame: every cycle ]
  • Phase 2 - To assess biomarkers relevant to enzastaurin and disease state and their correlation to clinical outcome [ Time Frame: baseline, cycle 2, end of study ]
  • Phase 2 - To explore the utility of magnetic resonance perfusion techniques to assess treatment with enzastaurin when possible [ Time Frame: each radiologic assessment ]
  • Phase 2 - To assess changes in health-related quality of life and symptoms in this patient population [ Time Frame: every cycle ]


Original Secondary Outcome:

  • Phase 1
  • To characterize the safety of enzastaurin when combined with temozolomide and radiation therapy in this setting
  • To characterize the pharmacokinetics of enzastaurin when administered in combination with temozolomide and radiation therapy
  • To assess biomarkers relevant to enzastaurin and disease state, and their correlation to clinical outcome
  • To assess for evidence of antitumor activity in this patient population
  • Phase 2
  • To evaluate progression free survival (PFS)
  • To evaluate the safety profile of enzastaurin in combination with temozolomide and radiation therapy in this patient population
  • To assess biomarkers relevant to enzastaurin and disease state and their correlation to clinical outcome
  • To explore the utility of magnetic resonance perfusion techniques to assess treatment with enzastaurin when possible
  • To assess changes in health-related quality of life and symptoms in this patient population


Information By: Eli Lilly and Company

Dates:
Date Received: November 17, 2006
Date Started: September 2006
Date Completion:
Last Updated: October 25, 2010
Last Verified: October 2010