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| ID | Type | Description | Link |
|---|---|---|---|
| B9E-MW-S368 |
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The primary endpoint of this study is to assess the objective tumor response rate in patients with advanced epithelial ovarian cancer receiving combination of Gemcitabine at a dose 1250 mg/m2 (Day 1 and 8) with Cisplatin 75 mg/m2 (Day 1) as first-line treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gemcitabine | Drug | 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best Overall Tumor Response | Best response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). | every other 21 day cycle (6-8 cycles), every 3 months during long-term follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response | The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. | every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up |
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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 thsi 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. | Irkutsk | Russia |
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| ID | Title | Description |
|---|---|---|
| FG000 | Gemcitabine + Cisplatin | Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity. Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gemcitabine + Cisplatin | Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity. Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity. |
| 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 | Best Overall Tumor Response | Best response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). | Posted | Number | participants | every other 21 day cycle (6-8 cycles), every 3 months during long-term follow-up |
|
|
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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 | Gemcitabine + Cisplatin | Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity. Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | 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 |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| cisplatin | Drug | 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity |
|
| Time to Progressive Disease |
Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause. |
| every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up |
| Time to Treatment Failure | Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed. | every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up |
| Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Grades range from 0 (no toxicity) to 4 (life-threatening or disabling). | every 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up |
| For additional information regarding investigative sites for thsi 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. | Ivanovo | Russia |
| For additional information regarding investigative sites for thsi 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. | Moscow | Russia |
| For additional information regarding investigative sites for thsi 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. | Saint Petersburg | Russia |
| For additional information regarding investigative sites for thsi 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. | Stavropol | Russia |
| Withdrawal by Subject |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Disease Stage | Number | participants |
|
| Eastern Cooperative Oncology Group Performance Status Score | Number | participants |
|
| Postoperational Pathomorphological Diagnosis | Number | participants |
|
| Race/Ethnicity | Number | participants |
|
| State of Patient Relative to Menopause | Number | participants |
|
| Time from Initial Diagnosis to Study Entry | Mean | Standard Deviation | days |
|
| Participants |
|
|
| Secondary | Duration of Response | The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. | Posted | Median | 95% Confidence Interval | weeks | every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up |
|
|
|
| Secondary | Time to Progressive Disease | Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause. | Posted | Median | 95% Confidence Interval | weeks | every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up |
|
|
|
| Secondary | Time to Treatment Failure | Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed. | Posted | Median | 95% Confidence Interval | weeks | every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up |
|
|
|
| Secondary | Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade | Grades range from 0 (no toxicity) to 4 (life-threatening or disabling). | Posted | Number | participants | every 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up |
|
|
|
| 2 |
| 48 |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Deafness | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Respiratory tract infection viral | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Creatinine renal clearance decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
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| D000291 |
| Adnexal Diseases |
| 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 |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| Title | Measurements |
|---|---|
|
| Patients with at least one CTC - Grade 4 |
|
| Other auditory/hearing - Grade 1 |
|
| Other auditory/hearing - Grade 2 |
|
| Other auditory/hearing - Grade 3 |
|
| Other auditory/hearing - Grade 4 |
|
| Leukocytes - Grade 1 |
|
| Leukocytes - Grade 2 |
|
| Leukocytes - Grade 3 |
|
| Leukocytes - Grade 4 |
|
| Neutrophils/granulocytes - Grade 1 |
|
| Neutrophils/granulocytes - Grade 2 |
|
| Neutrophils/granulocytes - Grade 3 |
|
| Neutrophils/granulocytes - Grade 4 |
|
| Fatigue - Grade 1 |
|
| Fatigue - Grade 2 |
|
| Fatigue - Grade 3 |
|
| Fatigue - Grade 4 |
|
| Weight loss - Grade 1 |
|
| Weight loss - Grade 2 |
|
| Weight loss - Grade 3 |
|
| Weight loss - Grade 4 |
|
| Alopecia - Grade 1 |
|
| Alopecia - Grade 2 |
|
| Alopecia - Grade 3 |
|
| Alopecia - Grade 4 |
|
| Rash/desquamation - Grade 1 |
|
| Rash/desquamation - Grade 2 |
|
| Rash/desquamation - Grade 3 |
|
| Rash/desquamation - Grade 4 |
|
| Anorexia - Grade 1 |
|
| Anorexia - Grade 2 |
|
| Anorexia - Grade 3 |
|
| Anorexia - Grade 4 |
|
| Diarrhea (without colostomy) - Grade 1 |
|
| Diarrhea (without colostomy) - Grade 2 |
|
| Diarrhea (without colostomy) - Grade 3 |
|
| Diarrhea (without colostomy) - Grade 4 |
|
| Nausea - Grade 1 |
|
| Nausea - Grade 2 |
|
| Nausea - Grade 3 |
|
| Nausea - Grade 4 |
|
| Other Gastrointestinal - Grade 1 |
|
| Other Gastrointestinal - Grade 2 |
|
| Other Gastrointestinal - Grade 3 |
|
| Other Gastrointestinal - Grade 4 |
|
| Stomatitis/pharyngitis - Grade 1 |
|
| Stomatitis/pharyngitis - Grade 2 |
|
| Stomatitis/pharyngitis - Grade 3 |
|
| Stomatitis/pharyngitis - Grade 4 |
|
| Vomiting - Grade 1 |
|
| Vomiting - Grade 2 |
|
| Vomiting - Grade 3 |
|
| Vomiting - Grade 4 |
|
| Alkaline phosphatase - Grade 1 |
|
| Alkaline phosphatase - Grade 2 |
|
| Alkaline phosphatase - Grade 3 |
|
| Alkaline phosphatase - Grade 4 |
|
| Bilirubin - Grade 1 |
|
| Bilirubin - Grade 2 |
|
| Bilirubin - Grade 3 |
|
| Bilirubin - Grade 4 |
|
| Serum glutamic oxaloacetic transaminase - Grade 1 |
|
| Serum glutamic oxaloacetic transaminase - Grade 2 |
|
| Serum glutamic oxaloacetic transaminase - Grade 3 |
|
| Serum glutamic oxaloacetic transaminase - Grade 4 |
|
| Serum glutamic pyruvic transaminase - Grade 1 |
|
| Serum glutamic pyruvic transaminase - Grade 2 |
|
| Serum glutamic pyruvic transaminase - Grade 3 |
|
| Serum glutamic pyruvic transaminase - Grade 4 |
|
| Dizziness/lightheadedness - Grade 1 |
|
| Dizziness/lightheadedness - Grade 2 |
|
| Dizziness/lightheadedness - Grade 3 |
|
| Dizziness/lightheadedness - Grade 4 |
|
| Headache - Grade 1 |
|
| Headache - Grade 2 |
|
| Headache - Grade 3 |
|
| Headache - Grade 4 |
|
| Creatinine - Grade 1 |
|
| Creatinine - Grade 2 |
|
| Creatinine - Grade 3 |
|
| Creatinine - Grade 4 |
|
| Renal failure - Grade 1 |
|
| Renal failure - Grade 2 |
|
| Renal failure - Grade 3 |
|
| Renal failure - Grade 4 |
|
| Renal/genitourinary - Other - Grade 1 |
|
| Renal/genitourinary - Other - Grade 2 |
|
| Renal/genitourinary - Other - Grade 3 |
|
| Renal/genitourinary - Other - Grade 4 |
|