Resultados da pesquisa - Portal para modelos de dados médicos (portal MDM)

Topotecan (HycamtinTM) with Carboplatin as First-Line Chemotherapy in Patients with Ovarian Cancer; 104864/612 - Cycle 1

- 12/08/2019 - 1 Formulário, 8 Grupos de itens, 45 Elementos de dados, 1 Idioma

Grupos de itens: Administrative documentation, Demography, Experimental drug, Topotecan, Administration of medication, Experimental drug, Carboplatin, Administration of medication, Laboratory Procedures, Hematology finding, Laboratory Procedures, Chemistry, Clinical, Urinalysis, Concomitant Agent

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

HYCAMTIN in Combination With Carboplatin in Subjects with Ovarian Cancer; NCT00316173 - Investigational Product - IV Dosing

- 07/08/2019 - 1 Formulário, 3 Grupos de itens, 111 Elementos de dados, 1 Idioma

Grupos de itens: Administrative documentation, Experimental drug, Dosage, Experimental drug, Dosage

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 - Serious Adverse Event (SAE)

- 17/07/2019 - 1 Formulário, 13 Grupos de itens, 51 Elementos de dados, 1 Idioma

Grupos de itens: Administrative documentation, Serious Adverse Event, Serious Adverse Event, Seriousness of Adverse Event, Serious Adverse Event, Demography, Serious Adverse Event, Relationships, Experimental drug, Serious Adverse Event, Etiology aspects, Serious Adverse Event, Disease, Relevance, Serious Adverse Event, Risk factors, Serious Adverse Event, Concomitant Agent, Serious Adverse Event, Experimental drug, Serious Adverse Event, Evaluation, Serious Adverse Event, Comment, Serious Adverse Event, Investigator Signature

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 - Study Conclusion

- 12/07/2019 - 1 Formulário, 2 Grupos de itens, 5 Elementos de dados, 1 Idioma

Grupos de itens: Administrative documentation, Conclusion, Clinical Research

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 - Concomitant Medications

- 12/07/2019 - 1 Formulário, 2 Grupos de itens, 8 Elementos de dados, 1 Idioma

Grupos de itens: Administrative documentation, Concomitant Agent

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 - Non-Serious Adverse Events (NSAE)

- 12/07/2019 - 1 Formulário, 2 Grupos de itens, 10 Elementos de dados, 1 Idioma

Grupos de itens: Administrative documentation, Non-serious Adverse Event

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 - Investigational Product Discontinuation

- 12/07/2019 - 1 Formulário, 2 Grupos de itens, 3 Elementos de dados, 1 Idioma

Grupos de itens: Administrative documentation, Experimental drug, Discontinuation

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 - Screen

- 12/07/2019 - 1 Formulário, 20 Grupos de itens, 101 Elementos de dados, 1 Idioma

Grupos de itens: Administrative documentation, Demography, Vital Signs, Ovarian Carcinoma, Prior Therapy, Drug toxicity, Current Medical Status, Due to, Malignant Neoplasms, Disease, Current, Ovarian carcinoma, Disease characteristic, Laboratory Procedures, CA-125 Antigen, Operative Surgical Procedure, Previous, Related to Cancer, Cancer Treatment, Previous, Lesion, Indicator, Evaluation, Non-Measurable Lesion, Evaluation, Therapeutic procedure, Therapeutic regimen, Eligibility Determination, Inclusion, Eligibility Determination, Inclusion, Exclusion Criteria, 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

Case Report Form Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv - Case Report Form (HIPEC)

- 12/02/2016 - 1 Formulário, 12 Grupos de itens, 226 Elementos de dados, 1 Idioma

Grupos de itens: Visit 1: Screening visit and informed consent, Medical history of first cancer diagnosis, Surgery, Prior treatment, Medical history, Vital signs and physical examination, Laboratory results, Blood cell count, CTCAE Staging/Preexisting symptoms, Inclusion criteria, Exclusion criteria, Inclusion of Patient

Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv EudraCT Nr.: 2010-024352-28 Principal investigator und authorized representative of Sponsor: PD Dr. med. Oliver Zivanovic Center for Obstetrics and Gynaecology University Hospital Bonn Sigmund-Freud-Str. 25 53105 Bonn Sponsor: Rheinische Friedrich-Wilhelms-Universität Bonn represented by the Dean of Medical Faculty

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

- 13/08/2019 - 1 Formulário, 4 Grupos de itens, 7 Elementos de dados, 1 Idioma

Grupos de itens: Administrative documentation, Serious Adverse Event, Questionnaires, Quality of life, Clinical Trials, Status

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

HYCAMTIN in Combination With Carboplatin in Subjects with Ovarian Cancer; NCT00316173 - Investigator Comment Log

- 15/07/2019 - 1 Formulário, 2 Grupos de itens, 3 Elementos de dados, 1 Idioma

Grupos de itens: Administrative documentation, Clinical Investigators, Comment

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 - Pregnancy Information

- 12/07/2019 - 1 Formulário, 2 Grupos de itens, 2 Elementos de dados, 1 Idioma

Grupos de itens: Administrative documentation, Pregnancy, Information

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

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