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Oral GW786034 treatment for ovarian cancer NCT00281632 - Screening Eligibility Criteria

- 20/09/21 - 1 modulo, 3 itemgroups, 31 elementi, 1 linguaggio

Itemgroups: Header, Inclusion Criteria, Exclusion Criteria

Study ID: 104450 Clinical Study ID: VEG104450 Study Title: This study is a non-randomized, open-label, multi-center Phase II study of GW786034 to evaluate the administration of oral GW786034 in subjects with ovarian cancer. Clinicaltrials.gov Identifier: NCT00281632 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: pazopanib Trade Name: Votrient Study Indication: Neoplasms, Ovarian CRF Pages: 722-853

Ovarian Cancer null Quality of Life - FACT-0 (Version 4), GOG-0202 - 2101017v3.0 - FACT-0 (Version 4), GOG-0202

- 20/09/21 - 1 modulo, 6 itemgroups, 39 elementi, 1 linguaggio

Itemgroups: Physical Well-Being, SOCIAL/FAMILY WELL-BEING, EMOTIONAL WELL_BEING, FUNCTIONAL WELL-BEING, Additional Concerns, CCRR MODULE

FACT-0 (Version 4), GOG-0202 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=BA8117F5-B6F7-2F74-E034-0003BA12F5E7

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

- 17/09/21 - 1 modulo, 19 itemgroups, 80 elementi, 1 linguaggio

Itemgroups: Administrative documentation, Assessment Date, Demography, Menopausal Status, Medical History, Symptoms, Study Start Date, Concomitant Agent, ECOG performance status, Personal history of malignant neoplasm, unspecified, Ovarian Carcinoma, Histology, Ovarian Carcinoma, Operative Surgical Procedures, Tumor stage, Tumor Markers, Physical Examination, Lower abdomen, X-Ray Computed Tomography, Plain x-ray, Electrocardiography, Questionnaires, Quality of life, Receptor

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

Oral GW786034 treatment for ovarian cancer NCT00281632 - Screening

- 15/03/21 - 1 modulo, 24 itemgroups, 129 elementi, 2 lingue

Itemgroups: Header, Eligibility Question, Demography, Physical examination, Disease Characteristics, Metastatic Disease Site, local laboratory, Residual toxicities related to previous therapy for cancer, Residual toxicities, Cancer related current medical conditions, Medical Conditions, non-cancer related medical conditions, Medical Conditions, Prior anti-cancer therapy, Prior anti-cancer therapy - medication, Prior anti-cancer therapy - radiotherapy, Vital signs, ECOG Performance Status Scale, 12 LEAD ECG, 12-lead ECG Abnormalities, Local Laboratory - Haematology, Local Laboratory - Clinical Chemistry, Urinalysis, Electronically transferred laboratory data

Study ID: 104450 Clinical Study ID: VEG104450 Study Title: This study is a non-randomized, open-label, multi-center Phase II study of GW786034 to evaluate the administration of oral GW786034 in subjects with ovarian cancer. Clinicaltrials.gov Identifier: NCT00281632 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: pazopanib Trade Name: Votrient Study Indication: Neoplasms, Ovarian CRF Pages: 722-853

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

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

- 20/11/19 - 1 modulo, 9 itemgroups, 29 elementi, 1 linguaggio

Itemgroups: Administrative documentation, Follow-up, Month, Clinical Trials, Result, X-Ray Computed Tomography, Tumor Markers, follow-up visit date, Response to treatment, Evaluation, Therapeutic procedure, Other, Investigator Signature

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

Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308 - Survival Information; Form D; Termination Record

- 03/09/19 - 1 modulo, 9 itemgroups, 29 elementi, 1 linguaggio

Itemgroups: Survival Information - Month of Report, Survival Information - Review of disease status, Survival Information - Outcome, Form D, Termination Record, Termination Record - Review of Disease Status, Termination Record - Best Overall Response, Termination Record - Study Conclusion, Termination Record - Investigator Signature

Study ID: 104864/627 Clinical Study ID: 104864/627 Study Title: An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00061308 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan, Gemcitabine Study Indication: Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer

Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308 - Adverse Events; Serious Adverse Event; Prior and Concomitant Medications

- 03/09/19 - 1 modulo, 8 itemgroups, 61 elementi, 1 linguaggio

Itemgroups: Administrative, Are there any non-serious adverse events to report?, Non-Serious adverse Events, Serious Adverse Event #1, Serious Adverse Event #1 - Relevant Laboratory Data, Serious Adverse Event #1 - Signature, Prior and Concomitant Medications, Prior and Concomitant Medications

Study ID: 104864/627 Clinical Study ID: 104864/627 Study Title: An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00061308 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan, Gemcitabine Study Indication: Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer

Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308 - Course -- Prior to next Course (Day 25 - 28) - Vital Signs; Tumor Marker (CA-125); Laboratory Tests; Lesion Assessment Record

- 02/09/19 - 1 modulo, 9 itemgroups, 41 elementi, 1 linguaggio

Itemgroups: Administrative, Vital Signs, Tumor Marker (CA-125), Laboratory Tests - Haematology, Laboratory Tests - Haematology , Laboratory Tests - Chemistry, Laboratory Tests - Chemistry , Lesion Assessment, Lesion Assessment Record

Study ID: 104864/627 Clinical Study ID: 104864/627 Study Title: An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00061308 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan, Gemcitabine Study Indication: Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer

Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308 - Course -- (Day 1) - Eligibility; Vital Signs; Administration of Study Medications

- 02/09/19 - 1 modulo, 6 itemgroups, 45 elementi, 1 linguaggio

Itemgroups: Administrative, Eligibility, Vital Signs, Administration of Study Medications, Topotecan Administration, Gemcitabine Administration

Study ID: 104864/627 Clinical Study ID: 104864/627 Study Title: An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00061308 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan, Gemcitabine Study Indication: Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer

Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308 - Course -- Prior to next Course (Day 25 - 28) - Review of Disease Status; Therapeutic Interventions; End of Course Eligibility; Unscheduled Laboratory Tests; Therapeutic Interventions Log

- 02/09/19 - 1 modulo, 7 itemgroups, 23 elementi, 1 linguaggio

Itemgroups: Administrative, Review of Disease Status, Therapeutic Interventions, End of Course Eligibility, Unscheduled Laboratory Tests - Hematology, Unscheduled Laboratory Tests - Hematology, Therapeutic Interventions

Study ID: 104864/627 Clinical Study ID: 104864/627 Study Title: An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00061308 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan, Gemcitabine Study Indication: Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer

Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308 - Course -- (Day 8 ) - Vital Signs; Hematology; Administration of Study Medications

- 02/09/19 - 1 modulo, 7 itemgroups, 45 elementi, 1 linguaggio

Itemgroups: Administrative, Day 8 Vital Signs, Hematology, Hematology, Day 8 Administration of Study Medications, Topotecan Administration, Gemicitabine Administration

Study ID: 104864/627 Clinical Study ID: 104864/627 Study Title: An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00061308 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan, Gemcitabine Study Indication: Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer

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