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| ID | Type | Description | Link |
|---|---|---|---|
| B9E-JE-MB21 | Other Identifier | Eli Lilly and Company |
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To investigate efficacy, safety and PK of GEM monotherapy after prior chemotherapy with anthracycline and taxane regimen for patients with metastatic breast cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Dose Level 1 - 1000 mg/m2 |
|
| B | Experimental | Dose Level 2 - 1250 mg/m2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gemcitabine | Drug | 1000 mg/m2, intravenous (IV), day 1 and day 8 every 21 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Response | Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment. | baseline to measured progressive disease |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response | For responders, the minimum and maximum of the duration of complete response, duration of partial response, and duration of overall response were summarized, and the median of response duration and its 95% confidence interval were calculated using the Kaplan-Meier estimation. | time of response to progressive disease |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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. | Aichi | Japan |
At Step 1, 6 participants each were assigned at Dose Level 1 (gemcitabine:1000 mg/ m2) and Dose Level 2 (gemcitabine:1250 mg/ m2) to determine the recommended dose for Step 2. At Step 2, an additional 56 participants received the recommended dose (Dose Level 2).
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose Level 1 | Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy. |
| FG001 | Dose Level 2 | Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dose Level 1 | Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy. |
| BG001 | Dose Level 2 | Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy. |
| 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 | Tumor Response | Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment. | Posted | Number | participants | baseline to measured progressive disease |
|
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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 | Dose Level 1 | Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 1-800-545-5979 |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| gemcitabine | Drug | 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days |
|
|
| Time to Progressive Disease |
Time from study enrollment to first date of disease progression. Time to disease progression was censored at date of death if death was due to other cause. The minimum and maximum of this parameter were summarized, and the median time to progression and its 95% confidence interval were calculated using the Kaplan-Meier estimation. |
| baseline to measured progressive disease |
| Survival at 1 Year | Results are reported as number of participants alive at one year. | baseline to date of death from any cause, evaluate at 1 year |
| Pharmacokinetics - Normalized Cmax | maximum gemcitabine plasma concentration normalized to 1250 milligrams per square meter of gemcitabine. | cycle 1 |
| Pharmacokinetics - Normalized Area Under the Curve | Area under the gemcitabine plasma concentration-time curve from time zero to infinity. Gemcitabine dose was normalized to 1250 milligrams per square meter. | cycle 1 |
| 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. | Chiba | Japan |
| 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. | Ehime | Japan |
| 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. | Fukuoka | Japan |
| 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. | Fukushima | Japan |
| 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. | Gunma | Japan |
| 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. | Hyōgo | Japan |
| 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. | Kanagawa | Japan |
| 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. | Kumamoto | Japan |
| 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. | Niigata | Japan |
| 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. | Osaka | Japan |
| 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. | Saitama | Japan |
| 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. | Tokyo | Japan |
| Progression of Disease |
|
| Lack of Efficacy |
|
| Withdrawal by Subject |
|
| Pathologic Aggrevation |
|
| Physician Decision |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status | Classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death). | Number | participants |
|
| Human Epidermal Growth Factor Receptor 2 Expression Status | Number | participants |
|
| Presence of Estrogen Hormone Receptor | Number | participants |
|
| Presence of Metastasis | Metastasis could occur in more than one site, resulting in a higher sum for all categories in the arm/group than the overall number of participants in the arm/group. | Number | participants |
|
| Presence of Progesterone Hormone Receptor | Number | participant |
|
| Time of Latest Chemotherapy Completion | Number | participants |
|
| Time to Recurrence | Number | participants |
|
| Height | Mean | Standard Deviation | centimeters |
|
| Weight | Mean | Standard Deviation | kilograms |
|
|
|
| Secondary | Duration of Response | For responders, the minimum and maximum of the duration of complete response, duration of partial response, and duration of overall response were summarized, and the median of response duration and its 95% confidence interval were calculated using the Kaplan-Meier estimation. | The 5 responding participants (complete response and partial response) at Dose Level 2. | Posted | Median | 95% Confidence Interval | months | time of response to progressive disease |
|
|
|
| Secondary | Time to Progressive Disease | Time from study enrollment to first date of disease progression. Time to disease progression was censored at date of death if death was due to other cause. The minimum and maximum of this parameter were summarized, and the median time to progression and its 95% confidence interval were calculated using the Kaplan-Meier estimation. | Posted | Median | 95% Confidence Interval | days | baseline to measured progressive disease |
|
|
|
| Secondary | Survival at 1 Year | Results are reported as number of participants alive at one year. | Posted | Number | participants | baseline to date of death from any cause, evaluate at 1 year |
|
|
|
| Secondary | Pharmacokinetics - Normalized Cmax | maximum gemcitabine plasma concentration normalized to 1250 milligrams per square meter of gemcitabine. | Pharmacokinetic data were available from 12 patients. | Posted | Geometric Mean | Full Range | nanograms per milliliter (ng/mL) | cycle 1 |
|
|
|
| Secondary | Pharmacokinetics - Normalized Area Under the Curve | Area under the gemcitabine plasma concentration-time curve from time zero to infinity. Gemcitabine dose was normalized to 1250 milligrams per square meter. | Pharmacokinetic data were available on 12 participants. | Posted | Geometric Mean | Full Range | nanograms times hour per milliliter | cycle 1 |
|
|
|
| 1 |
| 4 |
| EG001 | Dose Level 2 | Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy. | 10 | 34 |
| Cellulitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Catheterisation venous | Surgical and medical procedures | MedDRA 11.1 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Femur fracture | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Brain oedema | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 11.1 | Systematic Assessment |
|
| Raynaud's phenomenon | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | MedDRA 11.1 | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |