Symptoms and General Pathology

All Conditions

Neoplasms

Rare Diseases

Recurrence

Glioblastoma

Glioma

Disease Attributes

Astrocytoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Anticonvulsants

Bevacizumab

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

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).

enzastaurin

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

bevacizumab

Enzyme-inducing antiepileptic drugs (EIAED)

Non-enzyme inducing antiepileptic drugs (NEIAED)

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)

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

Trial of Enzastaurin and Bevacizumab in Participants With Recurrent Malignant Gliomas

A Phase II Trial of Enzastaurin in Combination With Bevacizumab in Adults With Recurrent Malignant Gliomas

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).

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.

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.

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.

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.

Genentech, Inc.

Eli Lilly and Company

Enzastaurin: 1125 milligrams (mg) loading dose on Day 1, followed by 500 mg, orally, daily, for participants who are on non-enzyme inducing antiepileptic drugs (NEIAED) for 4 weeks. Participants were evaluated after each cycle (4-week cycles).

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

Cycles repeated until there was evidence of progressive disease (PD), significant toxicity, withdrawal of consent, or other discontinuation criteria were met.

Enzastaurin + Bevacizumab (NEIAED)

Enzastaurin: 1125 mg loading dose on Day 1, followed by 875 mg, orally, daily, for participants who are on enzyme inducing antiepileptic drugs (EIAED) for 4 weeks. Participants were evaluated after each cycle (4-week cycles).

Bevacizumab: 10 mg/kg, IV, every 2 weeks. Participants were evaluated after each cycle (4-week cycles).

Cycles repeated until there was evidence of PD, significant toxicity, withdrawal of consent, or other discontinuation criteria were met.

Enzastaurin + Bevacizumab (EIAED)

Enzastaurin: 1125 mg loading dose on Day 1, followed by 500 mg, orally, daily, for participants who are on NEIAED for 4 weeks. Participants were evaluated after each cycle (4-week cycles).

Bevacizumab: 10 mg/kg, IV, every 2 weeks. Participants were evaluated after each cycle (4-week cycles).

Cycles repeated until there was evidence of PD, significant toxicity, withdrawal of consent, or other discontinuation criteria were met.

Enzastaurin: 1125 mg loading dose on Day 1, followed by 875 mg, orally, daily, for participants who are on EIAED for 4 weeks. Participants were evaluated after each cycle (4-week cycles).

Bevacizumab: 10 mg/kg, IV, every 2 weeks. Participants were evaluated after each cycle (4-week cycles).

Cycles repeated until there was evidence of PD, significant toxicity, withdrawal of consent, or other discontinuation criteria were met.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

All enrolled participants who received at least 1 dose of study drug.

Chief Medical Officer

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

All enrolled participants who received at least 1 dose of study drug. The number of participants censored are 7 for Enzastaurin + Bevacizumab NEIAED) group and 0 for Enzastaurin + Bevacizumab (EIAED) group.

Time to Progressive Disease (PD)

Overall Response Rate (ORR)

Data were not collected for any participant due to low samples.

To Evaluate Tumor Markers and Genes

Physical Well-Being Cycle 1

Physical Well-Being Cycle 2

Physical Well-Being Cycle 3

Physical Well-Being Cycle 4

Physical Well-Being Cycle 5

Physical Well-Being Cycle 6

Physical Well-Being Cycle 7

Physical Well-Being Cycle 8

Physical Well-Being Cycle 9

Physical Well-Being Cycle 10

Physical Well-Being Cycle 11

Physical Well-Being Cycle 12

Social/Family Well-Being Cycle 1

Social/Family Well-Being Cycle 2

Social/Family Well-Being Cycle 3

Social/Family Well-Being Cycle 4

Social/Family Well-Being Cycle 5

Social/Family Well-Being Cycle 6

Social/Family Well-Being Cycle 7

Social/Family Well-Being Cycle 8

Social/Family Well-Being Cycle 9

Social/Family Well-Being Cycle 10

Social/Family Well-Being Cycle 11

Social/Family Well-Being Cycle 12

Emotional Well-Being Cycle 1

Emotional Well-Being Cycle 2

Emotional Well-Being Cycle 3

Emotional Well-Being Cycle 4

Emotional Well-Being Cycle 5

Emotional Well-Being Cycle 6

Emotional Well-Being Cycle 7

Emotional Well-Being Cycle 8

Emotional Well-Being Cycle 9

Emotional Well-Being Cycle 10

Emotional Well-Being Cycle 11

Emotional Well-Being Cycle 12

Functional Well-Being Cycle 1

Functional Well-Being Cycle 2

Functional Well-Being Cycle 3

Functional Well-Being Cycle 4

Functional Well-Being Cycle 5

Functional Well-Being Cycle 6

Functional Well-Being Cycle 7

Functional Well-Being Cycle 8

Functional Well-Being Cycle 9

Functional Well-Being Cycle 10

Functional Well-Being Cycle 11

Functional Well-Being Cycle 12

All enrolled participants who received at least 1 dose of study drug and had HRQoL assessed at baseline and in the end of Cycles 1-12.

Spots Global Cancer Trial Database for Trial of Enzastaurin and Bevacizumab in Participants With Recurrent Malignant Gliomas

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial