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HYCAMTIN in Combination With Carboplatin in Subjects with Ovarian Cancer; NCT00316173 - Cycle 5

- 7/12/19 - 1 form, 3 itemgroups, 15 items, 1 language
Itemgroups: Administrative documentation, Laboratory Procedures, Hematology finding, Laboratory Procedures, Chemistry, Clinical
Study ID: 104864/902 Clinical Study ID: 104864/902 Study Title: An Open-Label, Single-Arm, Phase II Study of IV Weekly (Days 1 and 8 Every 21 Days) HYCAMTIN in Combination With Carboplatin (Day 1 Every 21 Days) as Second-Line Therapy in Subjects With Potentially Platinum-Sensitive Relapsed Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00316173 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: CARBOPLATIN Study Indication: Ovarian Cancer; Neoplasms, Ovarian

HYCAMTIN in Combination With Carboplatin in Subjects with Ovarian Cancer; NCT00316173 - Cycle 6

- 7/12/19 - 1 form, 3 itemgroups, 15 items, 1 language
Itemgroups: Administrative documentation, Laboratory Procedures, Hematology finding, Laboratory Procedures, Chemistry, Clinical
Study ID: 104864/902 Clinical Study ID: 104864/902 Study Title: An Open-Label, Single-Arm, Phase II Study of IV Weekly (Days 1 and 8 Every 21 Days) HYCAMTIN in Combination With Carboplatin (Day 1 Every 21 Days) as Second-Line Therapy in Subjects With Potentially Platinum-Sensitive Relapsed Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00316173 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: CARBOPLATIN Study Indication: Ovarian Cancer; Neoplasms, Ovarian

HYCAMTIN in Combination With Carboplatin in Subjects with Ovarian Cancer; NCT00316173 - Cycle 4

- 7/12/19 - 1 form, 3 itemgroups, 15 items, 1 language
Itemgroups: Administrative documentation, Laboratory Procedures, Hematology finding, Laboratory Procedures, Chemistry, Clinical
Study ID: 104864/902 Clinical Study ID: 104864/902 Study Title: An Open-Label, Single-Arm, Phase II Study of IV Weekly (Days 1 and 8 Every 21 Days) HYCAMTIN in Combination With Carboplatin (Day 1 Every 21 Days) as Second-Line Therapy in Subjects With Potentially Platinum-Sensitive Relapsed Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00316173 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: CARBOPLATIN Study Indication: Ovarian Cancer; Neoplasms, Ovarian

HYCAMTIN in Combination With Carboplatin in Subjects with Ovarian Cancer; NCT00316173 - Cycle 3

- 7/12/19 - 1 form, 3 itemgroups, 15 items, 1 language
Itemgroups: Administrative documentation, Laboratory Procedures, Hematology finding, Laboratory Procedures, Chemistry, Clinical
Study ID: 104864/902 Clinical Study ID: 104864/902 Study Title: An Open-Label, Single-Arm, Phase II Study of IV Weekly (Days 1 and 8 Every 21 Days) HYCAMTIN in Combination With Carboplatin (Day 1 Every 21 Days) as Second-Line Therapy in Subjects With Potentially Platinum-Sensitive Relapsed Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00316173 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: CARBOPLATIN Study Indication: Ovarian Cancer; Neoplasms, Ovarian

HYCAMTIN in Combination With Carboplatin in Subjects with Ovarian Cancer; NCT00316173 - Cycle 2

- 7/12/19 - 1 form, 3 itemgroups, 15 items, 1 language
Itemgroups: Administrative documentation, Laboratory Procedures, Hematology finding, Laboratory Procedures, Chemistry, Clinical
Study ID: 104864/902 Clinical Study ID: 104864/902 Study Title: An Open-Label, Single-Arm, Phase II Study of IV Weekly (Days 1 and 8 Every 21 Days) HYCAMTIN in Combination With Carboplatin (Day 1 Every 21 Days) as Second-Line Therapy in Subjects With Potentially Platinum-Sensitive Relapsed Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00316173 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: CARBOPLATIN Study Indication: Ovarian Cancer; Neoplasms, Ovarian

Lung Cancer Hematology/Chemistry NCT00324805 - Hematology/Chemistry Form Lung Cancer NCT00324805 E1505

- 3/27/15 - 1 form, 3 itemgroups, 29 items, 1 language
Itemgroups: Header, ON/Off TREATMENT, Hematology and Chemistry
E1505 Hematology/Chemistry Form Chemotherapy With or Without Bevacizumab in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-Small Lung Cancer That Was Removed By Surgery NCT00324805 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=26A1ECBB-6572-4421-E044-0003BA3F9857

Effects of Esomeprazole on Lapatinib in Subjects with Breast Cancer; 109275 - Day 1

- 6/15/20 - 1 form, 7 itemgroups, 180 items, 1 language
Itemgroups: Date of visit, Vital signs, 12 lead ECG, 12 lead ECG, Abnormality, Randomisation, Numbers, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Hematology finding
Study ID: 109275 Clinical Study ID: 109275 Study Title: An Open-Label, Single Sequence Study to Examine the Effects of Esomeprazole on the Pharmacokinetics of Orally Administered Lapatinib in Subjects with Metastatic ErbB2 Positive Breast Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib, Esomeprazole Trade Name: lapatinib plus esomeprazole Study Indication: Neoplasms, Breast

Effects of Esomeprazole on Lapatinib in Subjects with Breast Cancer; 109275 - Period 2 Visit

- 6/25/20 - 1 form, 8 itemgroups, 288 items, 1 language
Itemgroups: Date of visit, Vital signs, 12 lead ECG, 12 lead ECG, Abnormality, Pharmacokinetic aspects, Experimental drug, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Hematology finding
Study ID: 109275 Clinical Study ID: 109275 Study Title: An Open-Label, Single Sequence Study to Examine the Effects of Esomeprazole on the Pharmacokinetics of Orally Administered Lapatinib in Subjects with Metastatic ErbB2 Positive Breast Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib, Esomeprazole Trade Name: lapatinib plus esomeprazole Study Indication: Neoplasms, Breast

Effects of Esomeprazole on Lapatinib in Subjects with Breast Cancer; 109275 - Period 1 Visit

- 6/25/20 - 1 form, 9 itemgroups, 298 items, 1 language
Itemgroups: Date of visit, Vital signs, 12 lead ECG, 12 lead ECG, Abnormality, Pharmacokinetic aspects, Experimental drug, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Hematology finding, CYP2C19 gene, Genotype
Study ID: 109275 Clinical Study ID: 109275 Study Title: An Open-Label, Single Sequence Study to Examine the Effects of Esomeprazole on the Pharmacokinetics of Orally Administered Lapatinib in Subjects with Metastatic ErbB2 Positive Breast Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib, Esomeprazole Trade Name: lapatinib plus esomeprazole Study Indication: Neoplasms, Breast

Oral Topotecan Daily x 5 Days vs. Oral Topotacan 5 Days On, 2 Days Off; 104864/502 - Laboratory Tests

- 7/8/19 - 1 form, 4 itemgroups, 25 items, 1 language
Itemgroups: Administrative documentation, Laboratory Procedures, Hematology finding, Laboratory Procedures, Blood Chemical Analysis, Laboratory Procedures, Urinalysis
Study ID: 104864/502 Clinical Study ID: 104864/502 Study Title: An Open-Label, Multicenter, Randomized, Phase II Study of Oral Topotecan Daily x 5 Days vs. Oral Topotecan 5 Days On, 2 Days Off for 3 Weeks for Second-Line Treatment in Patients with Recurrent, Locally Advanced or Metastatic Cervical 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: N/A Study Indication: Cancer, Locally Advanced or Metastatic Cervical Cancer

Oral Topotecan Daily x 5 Days vs. Oral Topotacan 5 Days On, 2 Days Off; 104864/502 - Laboratory Tests

- 7/8/19 - 1 form, 4 itemgroups, 25 items, 1 language
Itemgroups: Administrative documentation, Laboratory Procedures, Hematology finding, Laboratory Procedures, Blood Chemical Analysis, Laboratory Procedures, Urinalysis
Study ID: 104864/502 Clinical Study ID: 104864/502 Study Title: An Open-Label, Multicenter, Randomized, Phase II Study of Oral Topotecan Daily x 5 Days vs. Oral Topotecan 5 Days On, 2 Days Off for 3 Weeks for Second-Line Treatment in Patients with Recurrent, Locally Advanced or Metastatic Cervical 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: N/A Study Indication: Cancer, Locally Advanced or Metastatic Cervical Cancer

Effects of Esomeprazole on Lapatinib in Subjects with Breast Cancer; 109275 - Follow-up

- 6/25/20 - 1 form, 10 itemgroups, 187 items, 1 language
Itemgroups: Date of visit, Vital signs, 12 lead ECG, 12 lead ECG, Abnormality, Experimental drug, Continuation status, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Hematology finding, Conclusion, Clinical Research, Cessation of life, Pregnancy, Information
Study ID: 109275 Clinical Study ID: 109275 Study Title: An Open-Label, Single Sequence Study to Examine the Effects of Esomeprazole on the Pharmacokinetics of Orally Administered Lapatinib in Subjects with Metastatic ErbB2 Positive Breast Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib, Esomeprazole Trade Name: lapatinib plus esomeprazole Study Indication: Neoplasms, Breast

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