Trial of Enzastaurin and Bevacizumab in Participants With Recurrent Malignant Gliomas

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.

Time frame: Registration to study completion up to 67.56 months

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

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 frame: Registration to 6 months

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

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.

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

Population: 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.

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.

Time frame: Baseline, Cycles 1-12 (4-week cycles)

Population: 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.

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.

Time frame: Registration to date of objective PD or death up to 66.56 months

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

Time frame: Baseline and every cycle (4-week cycles)

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