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Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410) - Screening - Prior an Concomitant Medication; Telephone Randomisation

- 18-04-21 - 1 Formular, 4 Itemgruppen, 13 Datenelemente, 1 Sprache
Itemgruppen: Administrative, Prior and Concomitant Medication, Prior and Concomitant Medication , Telephone Randomisation
Study ID: 104864/410 Clinical Study ID: 104864/410 Study Title: A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Study Indication: Lung Cancer

Topotecan (HycamtinTM) with Carboplatin as First-Line Chemotherapy in Patients with Ovarian Cancer; 104864/612 - Cycle 7

- 13-08-19 - 1 Formular, 4 Itemgruppen, 17 Datenelemente, 1 Sprache
Itemgruppen: Administrative documentation, Clinical Trials, Status, Experimental drug, Topotecan, Administration of medication, Experimental drug, Topotecan, Administration of medication
Study ID: 104864/612 Clinical Study ID: 104864/612 Study Title: A Prospective, Open Label Phase II Study to Evaluate the Efficacy and Safety of Topotecan (HycamtinTM) in Combination with Carboplatin as First-line Chemotherapy in Patients with Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: HycamtinTM Study Indication: Ovarian Cancer

Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410) - Laboratory Reference Ranges; Concomitant Medication; Adverse Experiences (Non-serious)

- 04-05-21 - 1 Formular, 7 Itemgruppen, 36 Datenelemente, 1 Sprache
Itemgruppen: Administrative, Laboratory Reference Ranges, Laboratory Reference Ranges , Concomitant Medication - Continued, Adverse Experiences (Non-serious), Adverse Experiences (Non-serious), Investigator's Signature (Adverse Experience)
Study ID: 104864/410 Clinical Study ID: 104864/410 Study Title: A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Study Indication: Lung Cancer

Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410) - Concomitant Medication; Adverse Experiences (Non-serious); Course Conclusion

- 27-04-21 - 1 Formular, 7 Itemgruppen, 31 Datenelemente, 1 Sprache
Itemgruppen: Administrative, Concomitant Medication, Adverse Experiences (Non-serious), Adverse Experiences (Non-serious), Investigator's Signature (Adverse Experience), Course Conclusion, Investigator's Signature (Study Conclusion)
Study ID: 104864/410 Clinical Study ID: 104864/410 Study Title: A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Study Indication: Lung Cancer

Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410) - Module 2 - Pre-Next Course: Serious Adverse Experiences; Vital Signs; 12-Lead ECG

- 29-04-21 - 1 Formular, 4 Itemgruppen, 14 Datenelemente, 1 Sprache
Itemgruppen: Administrative, Serious Adverse Experiences, Vital Signs , 12-Lead Electrocardiogram
Study ID: 104864/410 Clinical Study ID: 104864/410 Study Title: A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Study Indication: Lung Cancer

Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410) - Pre-Next Course: Serious Adverse Experiences; Vital Signs; 12-Lead ECG

- 27-04-21 - 1 Formular, 4 Itemgruppen, 14 Datenelemente, 1 Sprache
Itemgruppen: Administrative, Serious Adverse Experiences, Vital Signs , 12-Lead Electrocardiogram
Study ID: 104864/410 Clinical Study ID: 104864/410 Study Title: A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Study Indication: Lung Cancer

Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410) - Eligibility Criteria

- 20-04-21 - 1 Formular, 5 Itemgruppen, 27 Datenelemente, 1 Sprache
Itemgruppen: Administrative, Inclusion Criteria, Exclusion Criteria, Inclusion/ Exclusion, Investigator's Signature
Study ID: 104864/410 Clinical Study ID: 104864/410 Study Title: A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Study Indication: Lung Cancer

Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410) - Regimen 1 and Regimen 2: Days 1 - 5 - Weight/ Body Surface Area; Topotecan Study Medication Record; Pre-Cisplatin Hydration Record; Cisplatin Study Medication Record; Post-Cisplatin Hydration Record; Post-Cisplatin Dosing; Etoposide Study Medication Record; Vital Signs

- 28-04-21 - 1 Formular, 9 Itemgruppen, 51 Datenelemente, 1 Sprache
Itemgruppen: Administrative, Weight/Body Surface Area (Regimen 1, Regimen 2), Topotecan Study Medication Record (Regimen 1, Regimen 2), Day 5 Pre-Cisplatin Hydration Record (Regimen 1), Day 5 Cisplatin Study Medication Record (Regimen 1), Day 5 Post-Cisplatin Hydration Record (Regimen 1), Day 5 Vital Signs, Post-Cisplatin Dosing (Regimen 1), Etoposide Study Medication Record (Regimen 1, Regimen 2), Day 5 Vital Signs, Post-Etoposide Dosing (Regimen 2)
Study ID: 104864/410 Clinical Study ID: 104864/410 Study Title: A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Study Indication: Lung Cancer

Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410) - Module 2 - Laboratory Tests - Haematology; Blood Chemistry; Urinalysis

- 28-04-21 - 1 Formular, 4 Itemgruppen, 21 Datenelemente, 1 Sprache
Itemgruppen: Administrative, Laboratory Tests - Haematology, Laboratory Tests - Blood Chemistry, Laboratory Tests - Urinalysis
Study ID: 104864/410 Clinical Study ID: 104864/410 Study Title: A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Study Indication: Lung Cancer

Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410) - Laboratory Tests - Haematology; Blood Chemistry; Urinalysis

- 21-04-21 - 1 Formular, 4 Itemgruppen, 28 Datenelemente, 1 Sprache
Itemgruppen: Administrative, Laboratory Tests - Haematology, Laboratory Tests - Blood Chemistry, Laboratory Tests - Urinalysis
Study ID: 104864/410 Clinical Study ID: 104864/410 Study Title: A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Study Indication: Lung Cancer

Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410) - Screening - Toxicities Related to Previous Radiotherapy for SCLC; 12-Lead Electrocardiogram; Diagnostic Studies for Tumor Assessment; Ongoing Medical Conditions Associated with SCLC; Significant Medical/Surgical History and Physical Examination

- 17-04-21 - 1 Formular, 9 Itemgruppen, 20 Datenelemente, 1 Sprache
Itemgruppen: Administrative, Toxicities related to previous Radiotherapy for SCLC, Toxicities related to previous Radiotherapy for SCLC, 12-Lead Electrocardiogram, Diagnostic Studies for Tumor Assessment, Ongoing Medical Conditions Associated with SCLC, Ongoing Medical Conditions Associated with SCLC, Significant Medical/ Surgical History and Physical Examination, Significant Medical/ Surgical History and Physical Examination
Study ID: 104864/410 Clinical Study ID: 104864/410 Study Title: A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Study Indication: Lung Cancer

Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410) - Module 2 - Regimen 1 and Regimen 2: Days 1 - 5 - Weight/ Body Surface Area; Topotecan Study Medication Record; Pre-Cisplatin Hydration Record; Cisplatin Study Medication Record; Post-Cisplatin Hydration Record; Post-Cisplatin Dosing; Etoposide Study Medication Record; Vital Signs

- 28-04-21 - 1 Formular, 13 Itemgruppen, 63 Datenelemente, 1 Sprache
Itemgruppen: Administrative, Course Delay (Regimen 1, Regimen 2), Weight/Body Surface Area (Regimen 1, Regimen 2), Topotecan Study Medication Record (Regimen 1, Regimen 2), Topotecan Study Medication Record (Regimen 1, Regimen 2), Day 5 Pre-Cisplatin Hydration Record (Regimen 1), Day 5 Cisplatin Study Medication Record (Regimen 1), Cisplatin Study Medication Record, Day 5 Post-Cisplatin Hydration Record (Regimen 1), Day 5 Vital Signs, Post-Cisplatin Dosing (Regimen 1), Etoposide Study Medication Record (Regimen 2), Etoposide Study Medication Record , Day 5 Vital Signs, Post-Etoposide Dosing (Regimen 2)
Study ID: 104864/410 Clinical Study ID: 104864/410 Study Title: A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Study Indication: Lung Cancer

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