Trial of Enzastaurin and Bevacizumab in Participants With Recurrent Malignant Gliomas

NCT00586508 | Completed Phase 2 Results

• 2 other identifiers: 11394H6Q-MC-S033
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Recurrent Glioblastoma

Outcome Measures

Primary Outcomes (3)

• Progression-Free Survival at 6 Months (PFS-6)

  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).

  Registration to 6 months

• Time to Progressive Disease (PD)

  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.

  Registration to PD, death or date of last contact up to 66.56 months

• Number of Participants With Adverse Events (AEs) or Deaths (Safety)

  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.

  Registration to study completion up to 67.56 months

Secondary Outcomes (3)

• Overall Response Rate (ORR)

  Registration to date of objective PD or death up to 66.56 months

• To Evaluate Tumor Markers and Genes

  Baseline and every cycle (4-week cycles)

• Change From Baseline in Health-Related Quality of Life (HRQoL) Subscales

  Baseline, Cycles 1-12 (4-week cycles)

Study Arms (1)

Enzastaurin + Bevacizumab

EXPERIMENTAL

Drug: enzastaurin; Drug: bevacizumab; Drug: Enzyme-inducing antiepileptic drugs (EIAED); Drug: Non-enzyme inducing antiepileptic drugs (NEIAED)

Interventions

enzastaurin DRUG

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).

Also known as: LY317615

Enzastaurin + Bevacizumab

bevacizumab DRUG

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

Enzastaurin + Bevacizumab

Enzyme-inducing antiepileptic drugs (EIAED) DRUG

Administered orally

Enzastaurin + Bevacizumab

Non-enzyme inducing antiepileptic drugs (NEIAED) DRUG

Administered orally

Enzastaurin + Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 \[including aspirin, non-steroidal anti-inflammatories, Cyclooxygenase-2 (COX-2) inhibitors\]

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Genentech, Inc.: collaborator

Study Sites (1)

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

Location

Related Publications (2)

• Odia Y, Iwamoto FM, Moustakas A, Fraum TJ, Salgado CA, Li A, Kreisl TN, Sul J, Butman JA, Fine HA. A phase II trial of enzastaurin (LY317615) in combination with bevacizumab in adults with recurrent malignant gliomas. J Neurooncol. 2016 Mar;127(1):127-35. doi: 10.1007/s11060-015-2020-x. Epub 2015 Dec 7.

  PMID: 26643807 DERIVED

• Odia Y, Shih JH, Kreisl TN, Fine HA. Bevacizumab-related toxicities in the National Cancer Institute malignant glioma trial cohort. J Neurooncol. 2014 Nov;120(2):431-40. doi: 10.1007/s11060-014-1571-6. Epub 2014 Aug 7.

  PMID: 25098701 DERIVED

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Glioblastoma

Interventions

enzastaurin; Bevacizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2007
• First Posted: January 4, 2008
• Study Start: November 1, 2007
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: September 24, 2020
• Results First Posted: September 24, 2020

Record last verified: 2020-09

Locations

US (1)