Trial Outcomes & Findings for Evaluation of Enzastaurin in the Treatment of Persistent or Recurrent Ovarian or Primary Peritoneal Cancer (NCT NCT00420381)

NCT ID: NCT00420381

Last Updated: 2020-12-19

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

28 participants

Primary outcome timeframe

Baseline through 6 months

Results posted on

2020-12-19

Participant Flow

Completers are defined as receiving at least one dose of study drug and treated until progressive disease.

Participant milestones

Participant milestones
Measure	Enzastaurin 1125 mg oral loading dose enzastaurin then 500 mg, oral, daily, until progressive disease.
Overall Study STARTED	28
Overall Study Received at Least One Dose of Study Drug	27
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Enzastaurin 1125 mg oral loading dose enzastaurin then 500 mg, oral, daily, until progressive disease.
Overall Study Protocol Violation	1

Baseline Characteristics

Evaluation of Enzastaurin in the Treatment of Persistent or Recurrent Ovarian or Primary Peritoneal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enzastaurin n=27 Participants 1125 mg oral loading dose enzastaurin then 500 mg, oral, daily, until progressive disease.
Age, Continuous	61.4 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	27 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline through 6 months

Population: All participants who received at least 1 dose of study drug. 1 participant was censored.

Outcome measures

Outcome measures
Measure	Enzastaurin n=26 Participants 1125 mg oral loading dose enzastaurin then 500 mg, oral, daily, until progressive disease.
Progression-free Survival for at Least 6 Months (PFS-6)	10 Percentage of participants Interval 0.0 to 20.0

PRIMARY outcome

Timeframe: Baseline through end of study (Up to 45 months)

Population: All enrolled participants.

Data presented are the number of participants who experienced 1 or more adverse events (AEs) (all causalities and drug-related) and serious AEs (SAEs). A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this record.

Outcome measures

Outcome measures
Measure	Enzastaurin n=28 Participants 1125 mg oral loading dose enzastaurin then 500 mg, oral, daily, until progressive disease.
Number of Participants With Adverse Events and Severe Adverse Events Other AEs	27 Participants
Number of Participants With Adverse Events and Severe Adverse Events SAEs	12 Participants

SECONDARY outcome

Timeframe: Baseline to disease progression (Up to 38 months)

Population: All participants who received at least 1 dose of study drug, 1 participant was censored.

PFS is defined as the rate of PFS from the date of diagnosis to the first date of objectively determined progressive disease (based on radiological assessment) or death from any cause. It is assumed that PFS follows an exponential distribution.

Outcome measures

Outcome measures
Measure	Enzastaurin n=26 Participants 1125 mg oral loading dose enzastaurin then 500 mg, oral, daily, until progressive disease.
Duration of Progression-Free Survival	1.9 months Interval 1.5 to 2.7

SECONDARY outcome

Timeframe: Baseline

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

Participants who had disease progression within 6 months of ending their last regimen of platinum therapy were considered platinum resistant. Participants who had disease progression between 6 and 12 months of ending their last platinum regimen were considered platinum sensitive. Participants who had disease progression beyond 12 months of ending their last platinum regimen were also considered platinum sensitive.

Outcome measures

Outcome measures
Measure	Enzastaurin n=27 Participants 1125 mg oral loading dose enzastaurin then 500 mg, oral, daily, until progressive disease.
Prognostic Factors: Platinum Sensitivity Refractory Resistant (<6 months)	17 Participants
Prognostic Factors: Platinum Sensitivity Sensitive (>= 6months)	9 Participants
Prognostic Factors: Platinum Sensitivity Missing	1 Participants

SECONDARY outcome

Timeframe: Baseline

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

Performance Status 0 = Fully active, able to carry on all pre-disease performance without restriction Performance Status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work.

Outcome measures

Outcome measures
Measure	Enzastaurin n=27 Participants 1125 mg oral loading dose enzastaurin then 500 mg, oral, daily, until progressive disease.
Prognostic Factors: Performance Status Performance Status 0	16 Participants
Prognostic Factors: Performance Status Performance Status 1	11 Participants

SECONDARY outcome

Timeframe: Baseline through end of study (Up to 45 months)

Population: All participants who received at least one dose of study drug. 8 participants were censored.

Overall survival (OS) time is defined as the time from the date of diagnosis to the date of death from any cause. For participants who are still alive at the time of analysis, survival time will be censored at the last contact date.

Outcome measures

Outcome measures
Measure	Enzastaurin n=19 Participants 1125 mg oral loading dose enzastaurin then 500 mg, oral, daily, until progressive disease.
Overall Survival	15.1 Months Interval 9.5 to 33.3

Adverse Events

Enzastaurin

Serious events: 12 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Enzastaurin n=28 participants at risk 1125 mg oral loading dose enzastaurin then 500 mg, oral, daily, until progressive disease.
Cardiac disorders Hypertension	3.6% 1/28 • Number of events 1 All participants in study.
General disorders Fatigue (asthenia, lethargy, malaise)	7.1% 2/28 • Number of events 3 All participants in study.
General disorders Insomnia	3.6% 1/28 • Number of events 1 All participants in study.
General disorders Weight loss	3.6% 1/28 • Number of events 1 All participants in study.
General disorders Death not associated with ctcae term	10.7% 3/28 • Number of events 3 All participants in study.
Skin and subcutaneous tissue disorders Rash/desquamation	3.6% 1/28 • Number of events 2 All participants in study.
Gastrointestinal disorders Ascites (non-malignant)	7.1% 2/28 • Number of events 2 All participants in study.
Gastrointestinal disorders Constipation	7.1% 2/28 • Number of events 3 All participants in study.
Gastrointestinal disorders Dehydration	3.6% 1/28 • Number of events 1 All participants in study.
Gastrointestinal disorders Diarrhea	3.6% 1/28 • Number of events 2 All participants in study.
Gastrointestinal disorders Distension/bloating, abdominal	3.6% 1/28 • Number of events 2 All participants in study.
Gastrointestinal disorders Gastrointestinal - other (Ascites Malignant)	3.6% 1/28 • Number of events 1 All participants in study.
Gastrointestinal disorders Ileus, gi (functional obstruction of bowel, i.e., neuroconstipation)	3.6% 1/28 • Number of events 1 All participants in study.
Gastrointestinal disorders Incontinence, anal	3.6% 1/28 • Number of events 1 All participants in study.
Gastrointestinal disorders Nausea	7.1% 2/28 • Number of events 2 All participants in study.
Gastrointestinal disorders Obstruction, gi	14.3% 4/28 • Number of events 4 All participants in study.
Gastrointestinal disorders Vomiting	14.3% 4/28 • Number of events 5 All participants in study.
Blood and lymphatic system disorders Hemorrhage, gi	7.1% 2/28 • Number of events 2 All participants in study.
Blood and lymphatic system disorders Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)	3.6% 1/28 • Number of events 1 All participants in study.
General disorders Edema: limb	3.6% 1/28 • Number of events 2 All participants in study.
Metabolism and nutrition disorders Creatinine	3.6% 1/28 • Number of events 2 All participants in study.
Metabolism and nutrition disorders Potassium, serum-high (hyperkalemia)	3.6% 1/28 • Number of events 1 All participants in study.
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	3.6% 1/28 • Number of events 1 All participants in study.
Nervous system disorders Dizziness	3.6% 1/28 • Number of events 1 All participants in study.
General disorders Pain	14.3% 4/28 • Number of events 7 All participants in study.
Respiratory, thoracic and mediastinal disorders Aspiration	3.6% 1/28 • Number of events 1 All participants in study.
Respiratory, thoracic and mediastinal disorders Atelectasis	3.6% 1/28 • Number of events 1 All participants in study.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	10.7% 3/28 • Number of events 5 All participants in study.
Respiratory, thoracic and mediastinal disorders Pulmonary/upper respiratory - other (Malignant Pleural Effusion)	3.6% 1/28 • Number of events 2 All participants in study.
Vascular disorders Thrombosis/thrombus/embolism	3.6% 1/28 • Number of events 1 All participants in study.

Other adverse events

Other adverse events
Measure	Enzastaurin n=28 participants at risk 1125 mg oral loading dose enzastaurin then 500 mg, oral, daily, until progressive disease.
Immune system disorders Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)	14.3% 4/28 • Number of events 9 All participants in study.
Immune system disorders Allergy/immunology - other	7.1% 2/28 • Number of events 2 All participants in study.
General disorders Fatigue (asthenia, lethargy, malaise)	57.1% 16/28 • Number of events 35 All participants in study.
General disorders Insomnia	7.1% 2/28 • Number of events 2 All participants in study.
General disorders Sweating (diaphoresis)	7.1% 2/28 • Number of events 2 All participants in study.
Skin and subcutaneous tissue disorders Hair loss/alopecia (scalp or body)	7.1% 2/28 • Number of events 3 All participants in study.
Skin and subcutaneous tissue disorders Rash/desquamation	7.1% 2/28 • Number of events 9 All participants in study.
Gastrointestinal disorders Anorexia	35.7% 10/28 • Number of events 16 All participants in study.
Gastrointestinal disorders Ascites (non-malignant)	7.1% 2/28 • Number of events 3 All participants in study.
Gastrointestinal disorders Constipation	32.1% 9/28 • Number of events 18 All participants in study.
Gastrointestinal disorders Diarrhea	46.4% 13/28 • Number of events 20 All participants in study.
Gastrointestinal disorders Distension/bloating, abdominal	7.1% 2/28 • Number of events 2 All participants in study.
Gastrointestinal disorders Dry mouth/salivary gland (xerostomia)	10.7% 3/28 • Number of events 3 All participants in study.
Gastrointestinal disorders Heartburn/dyspepsia	7.1% 2/28 • Number of events 2 All participants in study.
Gastrointestinal disorders Nausea	35.7% 10/28 • Number of events 23 All participants in study.
Gastrointestinal disorders Taste alteration (dysgeusia)	7.1% 2/28 • Number of events 2 All participants in study.
Gastrointestinal disorders Vomiting	17.9% 5/28 • Number of events 6 All participants in study.
Infections and infestations Infection with normal anc or grade 1 or 2 neutrophils	21.4% 6/28 • Number of events 30 All participants in study.
General disorders Edema: limb	21.4% 6/28 • Number of events 9 All participants in study.
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	10.7% 3/28 • Number of events 5 All participants in study.
Metabolism and nutrition disorders Alkaline phosphatase	10.7% 3/28 • Number of events 4 All participants in study.
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	7.1% 2/28 • Number of events 2 All participants in study.
Metabolism and nutrition disorders Creatinine	7.1% 2/28 • Number of events 2 All participants in study.
Metabolism and nutrition disorders Glomerular filtration rate	10.7% 3/28 • Number of events 4 All participants in study.
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	10.7% 3/28 • Number of events 6 All participants in study.
Metabolism and nutrition disorders Magnesium, serum-low (hypomagnesemia)	7.1% 2/28 • Number of events 3 All participants in study.
Metabolism and nutrition disorders Potassium, serum-high (hyperkalemia)	7.1% 2/28 • Number of events 2 All participants in study.
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	7.1% 2/28 • Number of events 3 All participants in study.
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	14.3% 4/28 • Number of events 8 All participants in study.
General disorders Mood alteration	7.1% 2/28 • Number of events 3 All participants in study.
General disorders Pain	60.7% 17/28 • Number of events 32 All participants in study.
Respiratory, thoracic and mediastinal disorders Cough	7.1% 2/28 • Number of events 2 All participants in study.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	28.6% 8/28 • Number of events 10 All participants in study.
Renal and urinary disorders Urine color change	10.7% 3/28 • Number of events 7 All participants in study.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60