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| ID | Type | Description | Link |
|---|---|---|---|
| H6Q-MC-S025 | Other Identifier | Eli Lilly and Company |
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| Name | Class |
|---|---|
| Gynecologic Oncology Group | NETWORK |
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The purpose is to assess the efficacy and toxicity of the study agent, enzastaurin, in participants with recurrent or persistent ovarian cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enzastaurin | Drug | 1125 mg loading dose then 500 mg, oral, daily, until progressive disease |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival for at Least 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). | Baseline through 6 months |
| Number of Participants With Adverse Events and Severe Adverse Events | 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. | Baseline through end of study (Up to 45 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Progression-Free Survival | 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. | Baseline to disease progression (Up to 38 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lydia Usha | Gynecologic Oncology Group | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gynecologic Oncology Group 215-854-0770 | Philadelphia | Pennsylvania | 19103 | United States |
Completers are defined as receiving at least one dose of study drug and treated until progressive disease.
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| ID | Title | Description |
|---|---|---|
| FG000 | Enzastaurin | 1125 mg oral loading dose enzastaurin then 500 mg, oral, daily, until progressive disease. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Enzastaurin | 1125 mg oral loading dose enzastaurin then 500 mg, oral, daily, until progressive disease. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-free Survival for at Least 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). | All participants who received at least 1 dose of study drug. 1 participant was censored. | Posted | Number | 90% Confidence Interval | Percentage of participants | Baseline through 6 months |
|
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All participants in study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enzastaurin | 1125 mg oral loading dose enzastaurin then 500 mg, oral, daily, until progressive disease. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Cardiac disorders | MedDRA 6.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders | MedDRA 6.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D009369 | Neoplasms |
| D002277 | Carcinoma |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
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| ID | Term |
|---|---|
| C504878 | enzastaurin |
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| Prognostic Factors: Platinum Sensitivity |
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. |
| Baseline |
| Prognostic Factors: Performance Status | 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. | Baseline |
| Overall Survival | 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. | Baseline through end of study (Up to 45 months) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
|
|
| Primary | Number of Participants With Adverse Events and Severe Adverse Events | 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. | All enrolled participants. | Posted | Count of Participants | Participants | No | Baseline through end of study (Up to 45 months) |
|
|
|
| Secondary | Duration of Progression-Free Survival | 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. | All participants who received at least 1 dose of study drug, 1 participant was censored. | Posted | Median | 90% Confidence Interval | months | Baseline to disease progression (Up to 38 months) |
|
|
|
| Secondary | Prognostic Factors: Platinum Sensitivity | 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. | All participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Baseline |
|
|
|
| Secondary | Prognostic Factors: Performance Status | 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. | All participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Baseline |
|
|
|
| Secondary | Overall Survival | 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. | All participants who received at least one dose of study drug. 8 participants were censored. | Posted | Median | 90% Confidence Interval | Months | Baseline through end of study (Up to 45 months) |
|
|
|
| 12 |
| 28 |
| 27 |
| 28 |
| Fatigue (asthenia, lethargy, malaise) | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Insomnia | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Weight loss | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Death not associated with ctcae term | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders | MedDRA 6.0 | Systematic Assessment |
|
| Ascites (non-malignant) | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| Dehydration | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| Distension/bloating, abdominal | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| Gastrointestinal - other (Ascites Malignant) | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| Ileus, gi (functional obstruction of bowel, i.e., neuroconstipation) | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| Incontinence, anal | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| Obstruction, gi | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| Hemorrhage, gi | Blood and lymphatic system disorders | MedDRA 6.0 | Systematic Assessment |
|
| Petechiae/purpura (hemorrhage/bleeding into skin or mucosa) | Blood and lymphatic system disorders | MedDRA 6.0 | Systematic Assessment |
|
| Edema: limb | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Creatinine | Metabolism and nutrition disorders | MedDRA 6.0 | Systematic Assessment |
|
| Potassium, serum-high (hyperkalemia) | Metabolism and nutrition disorders | MedDRA 6.0 | Systematic Assessment |
|
| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders | MedDRA 6.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 6.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| Pulmonary/upper respiratory - other (Malignant Pleural Effusion) | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| Thrombosis/thrombus/embolism | Vascular disorders | MedDRA 6.0 | Systematic Assessment |
|
| Allergy/immunology - other | Immune system disorders | MedDRA 6.0 | Systematic Assessment |
|
| Fatigue (asthenia, lethargy, malaise) | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Insomnia | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Sweating (diaphoresis) | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Hair loss/alopecia (scalp or body) | Skin and subcutaneous tissue disorders | MedDRA 6.0 | Systematic Assessment |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders | MedDRA 6.0 | Systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| Ascites (non-malignant) | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| Distension/bloating, abdominal | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| Dry mouth/salivary gland (xerostomia) | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| Heartburn/dyspepsia | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| Taste alteration (dysgeusia) | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| Infection with normal anc or grade 1 or 2 neutrophils | Infections and infestations | MedDRA 6.0 | Systematic Assessment |
|
| Edema: limb | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | MedDRA 6.0 | Systematic Assessment |
|
| Alkaline phosphatase | Metabolism and nutrition disorders | MedDRA 6.0 | Systematic Assessment |
|
| Calcium, serum-low (hypocalcemia) | Metabolism and nutrition disorders | MedDRA 6.0 | Systematic Assessment |
|
| Creatinine | Metabolism and nutrition disorders | MedDRA 6.0 | Systematic Assessment |
|
| Glomerular filtration rate | Metabolism and nutrition disorders | MedDRA 6.0 | Systematic Assessment |
|
| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders | MedDRA 6.0 | Systematic Assessment |
|
| Magnesium, serum-low (hypomagnesemia) | Metabolism and nutrition disorders | MedDRA 6.0 | Systematic Assessment |
|
| Potassium, serum-high (hyperkalemia) | Metabolism and nutrition disorders | MedDRA 6.0 | Systematic Assessment |
|
| Potassium, serum-low (hypokalemia) | Metabolism and nutrition disorders | MedDRA 6.0 | Systematic Assessment |
|
| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders | MedDRA 6.0 | Systematic Assessment |
|
| Mood alteration | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| Urine color change | Renal and urinary disorders | MedDRA 6.0 | Systematic Assessment |
|
Not provided
| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|