Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial of Enzastaurin and Bevacizumab in Participants With Recurrent Malignant Gliomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00586508
Recruitment Status : Completed
First Posted : January 4, 2008
Results First Posted : September 24, 2020
Last Update Posted : September 24, 2020
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The purpose of this study is to evaluate both enzastaurin and bevacizumab in the treatment of recurrent malignant gliomas.

Condition or disease Intervention/treatment Phase
Recurrent Glioblastoma Drug: enzastaurin Drug: bevacizumab Drug: Enzyme-inducing antiepileptic drugs (EIAED) Drug: Non-enzyme inducing antiepileptic drugs (NEIAED) Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Enzastaurin in Combination With Bevacizumab in Adults With Recurrent Malignant Gliomas
Study Start Date : November 2007
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: Enzastaurin + Bevacizumab Drug: enzastaurin
1125 milligrams (mg) loading dose then 500 or 875 mg, orally, daily, 4-week cycles with participants evaluated after each cycle. The dose difference is for participants who are on enzyme-inducing antiepileptic drugs (EIAED) versus non-enzyme inducing antiepileptic drugs (NEIAED).
Other Name: LY317615

Drug: bevacizumab
10 milligrams per kilogram (mg/kg), intravenously (IV), every 2 weeks, participants are evaluated after each cycle (4-week cycles).

Drug: Enzyme-inducing antiepileptic drugs (EIAED)
Administered orally

Drug: Non-enzyme inducing antiepileptic drugs (NEIAED)
Administered orally




Primary Outcome Measures :
  1. Progression-Free Survival at 6 Months (PFS-6) [ Time Frame: Registration to 6 months ]
    Data presented are the percentage of participants without progressive disease (PD) or death from any cause 6 months after registration. PD was a 25% increase in the sum of products of all measurable lesions (or 2 largest lesions if too numerous) over the smallest sum observed (over baseline if no decrease) or clear worsening of any evaluable disease, or appearance of any new lesion/site, or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).

  2. Time to Progressive Disease (PD) [ Time Frame: Registration to PD, death or date of last contact up to 66.56 months ]
    Defined as the time from registration to PD, death or date of last contact. PD was a 25% increase in the sum of products of all measurable lesions (or 2 largest lesions if too numerous) over the smallest sum observed (over baseline if no decrease) or clear worsening of any evaluable disease, or appearance of any new lesion/site, or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). Participants who had no PD or death at the time of the data inclusion cutoff, time to PD was censored at their last tumor assessment prior to the cutoff date.

  3. Number of Participants With Adverse Events (AEs) or Deaths (Safety) [ Time Frame: Registration to study completion up to 67.56 months ]
    Data presented are the number of participants who experienced serious adverse events (SAEs), other non-serious AEs and deaths during the study including the 30-day follow-up. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.


Secondary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: Registration to date of objective PD or death up to 66.56 months ]
    Overall response is confirmed complete response (CR) + partial response (PR). CR is complete disappearance of all measurable and evaluable disease, no new lesions, and no evidence of non-evaluable disease. PR is ≥50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions (or the 2 largest lesions), no progression of evaluable disease and no new lesions. ORR is calculated as (total number of participants with CR or PR from the start of registration until disease progression) / (the total number of participants treated)*100.

  2. To Evaluate Tumor Markers and Genes [ Time Frame: Baseline and every cycle (4-week cycles) ]
  3. Change From Baseline in Health-Related Quality of Life (HRQoL) Subscales [ Time Frame: Baseline, Cycles 1-12 (4-week cycles) ]
    HRQoL was assessed with the Functional Assessment of Cancer Therapy - Brain (FACT-Br) version 4. The instrument consists of 50 items with a 5-point rating scale for each item, where 0 = "not at all" and 4 = "very much." Physical well-being, social/family well-being and functional well-being subscales consist of 7 items each with scores ranging from 0-28. The emotional well-being subscale consists of 6 items with a score ranging from 0-24. The brain cancer-specific subscale consists of 23 items with a score ranging from 0-92. Higher scores in each subscale represent better QoL. Changes from baseline in the 4 core subscales are presented.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant must be at least 18 years old
  • Participant must have been diagnosed with a recurrent brain tumor by magnetic resonance imaging (MRI) scan
  • Participant must be willing to practice adequate contraception
  • Participant must be able to swallow the enzastaurin tablets whole and receive bevacizumab intravenously
  • Participant must agree to use the study drug only as instructed by your study doctor and staff.

Exclusion Criteria:

  • Women who are pregnant or breastfeeding
  • Participants who have significant heart, liver, kidney, or psychiatric disease
  • Participants who have an active infection
  • Participants who have any recent bleeding in the brain
  • Participants who are taking any anti-coagulation or anti-platelet medication [including aspirin, non-steroidal anti-inflammatories, Cyclooxygenase-2 (COX-2) inhibitors]

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): NCT00586508


Locations
Layout table for location information
United States, Maryland
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.
Bethesda, Maryland, United States
Sponsors and Collaborators
Eli Lilly and Company
Genentech, Inc.
Investigators
Layout table for investigator information
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00586508    
Obsolete Identifiers: NCT00559923
Other Study ID Numbers: 11394
H6Q-MC-S033 ( Other Identifier: Eli Lilly and Company )
First Posted: January 4, 2008    Key Record Dates
Results First Posted: September 24, 2020
Last Update Posted: September 24, 2020
Last Verified: September 2020
Additional relevant MeSH terms:
Layout table for MeSH terms
Glioblastoma
Glioma
Astrocytoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Bevacizumab
Anticonvulsants
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors