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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 modulo, 7 itemgroups, 36 elementi, 1 linguaggio

Itemgroups: 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) - Module 2 - Pre-Next Course: Serious Adverse Experiences; Vital Signs; 12-Lead ECG

- 29/04/21 - 1 modulo, 4 itemgroups, 14 elementi, 1 linguaggio

Itemgroups: 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) - Module 2 - Laboratory Tests - Haematology; Blood Chemistry; Urinalysis

- 28/04/21 - 1 modulo, 4 itemgroups, 21 elementi, 1 linguaggio

Itemgroups: 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) - 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 modulo, 9 itemgroups, 51 elementi, 1 linguaggio

Itemgroups: 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 - 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 modulo, 13 itemgroups, 63 elementi, 1 linguaggio

Itemgroups: 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

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 modulo, 7 itemgroups, 31 elementi, 1 linguaggio

Itemgroups: 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) - Pre-Next Course: Serious Adverse Experiences; Vital Signs; 12-Lead ECG

- 27/04/21 - 1 modulo, 4 itemgroups, 14 elementi, 1 linguaggio

Itemgroups: 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) - Laboratory Tests - Haematology; Blood Chemistry; Urinalysis

- 21/04/21 - 1 modulo, 4 itemgroups, 28 elementi, 1 linguaggio

Itemgroups: 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) - Eligibility Criteria

- 20/04/21 - 1 modulo, 5 itemgroups, 27 elementi, 1 linguaggio

Itemgroups: 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) - Screening - Prior an Concomitant Medication; Telephone Randomisation

- 18/04/21 - 1 modulo, 4 itemgroups, 13 elementi, 1 linguaggio

Itemgroups: 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

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 modulo, 9 itemgroups, 20 elementi, 1 linguaggio

Itemgroups: 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

Cisplatin and Topotecan Recurrent or Persistent Carcinoma of the Cervix - 103369 - Pathology Report

- 31/12/19 - 1 modulo, 6 itemgroups, 20 elementi, 1 linguaggio

Itemgroups: Administrative data, Primary, Histology Type, Histologic Grade, Specimens, Secondary

Study ID: 103369 Clinical Study ID: 103369 Study Title: A Randomized Phase III Study of Cisplatin Versus Cisplatin plus Topotecan Versus MVAC in Stage IVB, Recurrent or Persistent Squamous Cell Carcinoma of the Cervix Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: Topotecan Study Indication: Cancer

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