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

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ClinicalTrials.gov Identifier: NCT00402116
Recruitment Status : Completed
First Posted : November 22, 2006
Last Update Posted : October 27, 2010
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by:
Eli Lilly and Company

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.


Condition or disease Intervention/treatment Phase
Glioblastoma Glioblastoma Multiforme Gliosarcoma Drug: enzastaurin Drug: temozolomide Radiation: radiation Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1/2 Study of Enzastaurin Plus Temozolomide During and Following Radiation Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma
Study Start Date : September 2006
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A Drug: enzastaurin
Phase 1 - 250 mg Cohort 1 with one dose escalation allowed to 500 mg for Cohort 2, oral, daily, 6 weeks then twelve 28 day cycles Phase 2 - Phase 1 established dose, oral, daily, 6 weeks then twelve 28 day cycles
Other Name: LY317615
Drug: temozolomide
75 mg/m2, oral, daily, 6 weeks 200 mg/m2, oral, daily, twelve 28 day cycles
Radiation: radiation
1.8-2.0 Gy x 30 fractions, 5 days/week, for 6 weeks



Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. Phase 1 - To characterize the safety of enzastaurin when combined with temozolomide and radiation therapy in this setting [ Time Frame: every cycle ]
  2. Phase 1 - To characterize the pharmacokinetics of enzastaurin when administered in combination with temozolomide and radiation therapy [ Time Frame: cycle 1, cycle 2 ]
  3. 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 ]
  4. Phase 1 - To assess for evidence of antitumor activity in this patient population [ Time Frame: baseline, following radiation, every other cycle ]
  5. Phase 2 - To evaluate progression free survival (PFS) [ Time Frame: baseline to measured progressive disease ]
  6. Phase 2 - To evaluate the safety profile of enzastaurin in combination with temozolomide and radiation therapy in this patient population [ Time Frame: every cycle ]
  7. 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 ]
  8. Phase 2 - To explore the utility of magnetic resonance perfusion techniques to assess treatment with enzastaurin when possible [ Time Frame: each radiologic assessment ]
  9. Phase 2 - To assess changes in health-related quality of life and symptoms in this patient population [ Time Frame: every cycle ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have a histologically confirmed diagnosis of intracranial glioblastoma multiforme (GBM) or gliosarcoma (GS).
  • Biopsy or resection must have been performed no more than 5 weeks prior to treatment.
  • An MRI or CT scan must be obtained within 14 days prior to treatment.
  • Patients must not have received prior drug therapy for brain tumors.
  • Patients must have adequate organ function demonstrated by lab tests within 14 days prior to treatment.

Exclusion Criteria:

  • Patients will be excluded if unable to swallow tablets.
  • Patients will be excluded if unable to discontinue use of enzyme inducing antiepileptic drugs or have been off of these agents less than 2 weeks prior to treatment (i.e. phenytoin (Dilantin), carbamazepine, etc.).
  • Patients will be excluded if have active infection.
  • Patients will be excluded if have a significant medical illness that, in the investigator's opinion, cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy.
  • Patients will be excluded if they have concurrent therapy with an anticoagulant. If the patient requires anticoagulant therapy after starting treatment, the patient may remain on study but should be monitored carefully.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00402116


Locations
United States, California
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
San Francisco, California, United States
Sponsors and Collaborators
Eli Lilly and Company
University of California, San Francisco
Investigators
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

Additional Information:
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00402116     History of Changes
Other Study ID Numbers: 9815
H6Q-MC-S008 ( Other Identifier: Eli Lilly and Company )
First Posted: November 22, 2006    Key Record Dates
Last Update Posted: October 27, 2010
Last Verified: October 2010

Additional relevant MeSH terms:
Glioblastoma
Gliosarcoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents