Trial of Enzastaurin and Bevacizumab in Participants With Recurrent Malignant Gliomas
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|ClinicalTrials.gov Identifier: NCT00586508|
Recruitment Status : Completed
First Posted : January 4, 2008
Results First Posted : September 24, 2020
Last Update Posted : September 24, 2020
|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||81 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Experimental: Enzastaurin + Bevacizumab||
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
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)
Drug: Non-enzyme inducing antiepileptic drugs (NEIAED)
- 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).
- 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.
- 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.
- 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.
- To Evaluate Tumor Markers and Genes [ Time Frame: Baseline and every cycle (4-week cycles) ]
- 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.
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
|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|
|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|