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Physical Exam Cancer Prevention

- 30-07-15 - 1 Formulier, 3 Itemgroepen, 29 Data-elementen, 1 Taal
Itemgroepen: Header, Physical Exam, DCP Template Footer
On-Study - Physical Exam - 2803173v1.0 The Division of Cancer Prevention's physical exam case report form (CRF) template. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=5C0F9C5A-FB66-15A0-E044-0003BA3F9857

Oral GW786034 treatment for ovarian cancer NCT00281632 - Screening

- 15-03-21 - 1 Formulier, 24 Itemgroepen, 129 Data-elementen, 2 Talen
Itemgroepen: 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

Oral GW786034 treatment for ovarian cancer NCT00281632 - Post-Treatment Assessments

- 16-05-18 - 1 Formulier, 12 Itemgroepen, 54 Data-elementen, 1 Taal
Itemgroepen: Header, Vital signs, ECOG Performance Status Scale, Electronically transferred laboratory data, Physical examination, serum pregnancy test, CONCOMITANT MEDICATIONS, ADVERSE EVENTS, Local Laboratory - Haematology, Local Laboratory - Clinical Chemistry, Urinalysis, 12 LEAD ECG
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

CLINICAL ASSESSMENT Roche H0650g Breast Cancer - CLINICAL ASSESSMENT

- 16-05-17 - 1 Formulier, 1 Itemgroep, 2 Data-elementen, 1 Taal
Itemgroep: CLINICAL ASSESSMENT
Study part: Clinical assessment. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche"

BASELINE PHYSICAL EXAMINATION Roche H0650g Breast Cancer - BASELINE PHYSICAL EXAMINATION

- 17-05-17 - 1 Formulier, 1 Itemgroep, 37 Data-elementen, 1 Taal
Itemgroep: PHYSICAL EXAMINATION
Study part: Baseline physical examination. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche"

12-LEAD ELECTROCARDIOGRAM Roche H0650g Breast Cancer - 12-LEAD ELECTROCARDIOGRAM

- 16-05-17 - 1 Formulier, 1 Itemgroep, 5 Data-elementen, 1 Taal
Itemgroep: 12-LEAD ELECTROCARDIOGRAM
Study part: 12- Lead electrocardiogram. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche"

PULMONARY FUNCTION TEST Roche H0650g Breast Cancer - PULMONARY FUNCTION TEST

- 16-05-17 - 1 Formulier, 1 Itemgroep, 3 Data-elementen, 1 Taal
Itemgroep: PULMONARY FUNCTION TEST
Study part: Pulmonary function test. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche"

STUDY TERMINATION CLINICAL ASSESSMENT Roche H0650g Breast Cancer - STUDY TERMINATION CLINICAL ASSESSMENT

- 20-05-17 - 1 Formulier, 1 Itemgroep, 4 Data-elementen, 1 Taal
Itemgroep: CLINICAL ASSESSMENT
Study part: Study termination clinical assessment. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche"

STUDY TERMINATION PHYSICAL EXAMINATION Roche H0650g Breast Cancer - STUDY TERMINATION PHYSICAL EXAMINATION

- 20-05-17 - 1 Formulier, 1 Itemgroep, 47 Data-elementen, 1 Taal
Itemgroep: PHYSICAL EXAMINATION
Study part: Study termination physical examination. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche"

WEEK 96 PHYSICAL EXAMINATION Roche H0650g Breast Cancer - WEEK 96 PHYSICAL EXAMINATION

- 17-05-17 - 1 Formulier, 1 Itemgroep, 39 Data-elementen, 1 Taal
Itemgroep: PHYSICAL EXAMINATION
Study part: Week 96 physical examination. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche"

WEEK 2 (DAY 7) INFUSION Roche H0650g Breast Cancer - WEEK 2 (DAY 7) INFUSION

- 21-05-17 - 1 Formulier, 3 Itemgroepen, 48 Data-elementen, 1 Taal
Itemgroepen: Infusion, INFUSION, Vital Signs
Study part: Week 2 (Day 7) Infusion. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche"

Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308 - Screening - Significant Medical/ Surgical History and Physical Examination; History of Ovarian Cancer; Tumor Marker

- 23-08-19 - 1 Formulier, 6 Itemgroepen, 18 Data-elementen, 1 Taal
Itemgroepen: Administrative, Significant Medical/ Surgical History and Physical Examination, Significant Medical/ Surgical History and Physical Examination , History of Ovarian Cancer, Metastatic, Tumor Marker (CA-125) (7 days prior to Day 1)
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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