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Eligibility Colorectal Cancer Screening NCT00705731

- 2017-02-28 - 1 Formulär, 2 Item-grupper, 10 Dataelement, 1 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
Adherence and the Economics of Colon Cancer Screening; ODM derived from: https://clinicaltrials.gov/show/NCT00705731

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

- 2021-09-17 - 1 Formulär, 19 Item-grupper, 296 Dataelement, 1 Språk
Item-grupper: Screening procedure, Enrollment, Date of visit, Demography, Eligibility Determination, Inclusion, Exclusion Criteria, Echocardiography, Multiple gated acquisition scanning, Disease, Disease Characteristic, cancer treatment, Prior Therapy, Therapeutic radiology procedure, cancer treatment, Vital signs, 12 lead ECG, 12 lead ECG, Abnormality, Randomisation, Numbers, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Hematology finding, Clinical Trial Subject Unique Identifier
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

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

- 2019-07-12 - 1 Formulär, 20 Item-grupper, 101 Dataelement, 1 Språk
Item-grupper: 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

XELODA and Lapatinib Advanced or Metastatic Breast Cancer Screening NCT00078572

- 2021-09-20 - 1 Formulär, 11 Item-grupper, 122 Dataelement, 1 Språk
Item-grupper: Pharmacogenetic Research - Blood - Informed Consent, Pharmacogenetic Research - Tumor - Informed Consent, Inclusion Criteria Worksheet, Exclusion Criteria Worksheet, Inclusion and Exclusion Criteria, Current Medical Conditions / Baseline Signs and Symptoms, Physical Exam (Vital Signs, Weight, Height), ECOG Performance Status, Cardiac Assessments Screening, Hematology, Clinical Chemistry
XELODA and Lapatinib Advanced or Metastatic Breast Cancer Study ID: 100151 Clinical Study ID: EGF100151 Study Title: A Phase III, Randomized, Open-label, Multicenter Study Comparing GW572016 and Capecitabine (XELODA) versus Capecitabine in Women with Refractory Advanced or Metastatic Breast Cancer Clinicaltrials.gov Identifier: NCT00078572 https://clinicaltrials.gov/ct2/show/NCT00078572 Procedure: Screening Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: lapatinib Trade Name: Tyverb,Tykerb,Tycerb Study Indication: Breast Cancer; Neoplasms, Breast

Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886 - Screening

- 2019-08-16 - 1 Formulär, 12 Item-grupper, 75 Dataelement, 1 Språk
Item-grupper: Administrative documentation, Demography, Vital signs, Rectal Carcinoma, Medical History, Rectal Carcinoma, Operative Surgical Procedures, Previous, 12 lead ECG, Rectal Carcinoma, Evaluation, Diagnostic procedure, Disease, Relationships, Rectal Carcinoma, Medical History; History of surgical procedures; Physical Examination, Pharmaceutical Preparations, Previous; Concomitant Agent, Inclusion, Exclusion Criteria
Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

Lapatinib + Topotecan or + Capecitabine in Recurrent Brain Metastases from Breast Cancer; NCT00437073 - Screening

- 2020-10-13 - 1 Formulär, 24 Item-grupper, 273 Dataelement, 1 Språk
Item-grupper: Date of visit, Assessment Date, Trial Screening, Enrollment, Clinical Trial Subject Unique Identifier, Demography, Eligibility Determination, Inclusion, Exclusion Criteria, disease characteristic, disease characteristic, Neoplasm Metastasis, Electrocardiography, Echocardiography; Multiple gated acquisition scanning, Laboratory Procedures, Central Laboratory; Laboratory Procedures, Local, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Hematology finding, Central Laboratory, Data, Disease, Operative Surgical Procedures, Disease, Relationships, Disease, Clinical Trials, Therapeutic procedures, Relationships, Disease, Cancer treatment, Prior Therapy, Neurologic Examination, Vital signs, Prior Radiation Therapy, Prior Radiation Therapy, Central Nervous System
Study ID: 107671 Clinical Study ID: 107671 Study Title: EGF107671 – A Phase II Study of Lapatinib plus Topotecan or Lapatinib plus Capecitabine in the Treatment of Recurrent Brain Metastases from ErbB2-Positive Breast Cancer Following Cranial Radiotherapy Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00437073 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: N/A Trade Name: capecitabine, topotecan, lapatinib Study Indication: Neoplasms, Breast; Recurrent Brain Metastases

Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410) - Screening - Prior an Concomitant Medication; Telephone Randomisation

- 2021-04-18 - 1 Formulär, 4 Item-grupper, 13 Dataelement, 1 Språk
Item-grupper: 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

- 2021-04-17 - 1 Formulär, 9 Item-grupper, 20 Dataelement, 1 Språk
Item-grupper: 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

Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410) - Module 1 - Screening (Demography; Vital Signs; History of Small Cell Lung Cancer; Previous Radiotherapy for Small Cell Lung Cancer; Previous Radiotherapy for Small Cell Lung Cancer

- 2021-04-08 - 1 Formulär, 8 Item-grupper, 29 Dataelement, 1 Språk
Item-grupper: Administrative, Demography, Vital Signs, History of Small Cell Lung Cancer, Previous Surgical Procedures for Small Cell Lung Cancer, Previous Surgical Procedures for Small Cell Lung Cancer , Previous Radiotherapy for Small Cell Lung Cancer, Previous Radiotherapy for Small Cell Lung Cancer
lung 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

Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer NCT00549328 - Screening - Subject Identification; Demography; Disease Characteristics; Status at Screening; Anti-Cancer Therapy; Anti-Cancer Radiotherapy; Medical Conditions

- 2021-03-15 - 1 Formulär, 12 Item-grupper, 64 Dataelement, 1 Språk
Item-grupper: Inform Screening, Subject number, Date of Visit/ Assessment, Local Laboratories, Subject identification, Demography, Disease Characteristics, Metastatic Disease, Status at Screening, Anti-Cancer Therapy, Anti-Cancer Therapy , Medical Conditions
Study ID: 109609 Clinical Study ID: 109609 Study Title: A Phase II, Non-randomized, Multi-center Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00549328 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GW786034 Trade Name: Drug: Pazopanib Study Indication: Lung Cancer, Non-Small Cell

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

- 2019-07-05 - 1 Formulär, 18 Item-grupper, 96 Dataelement, 1 Språk
Item-grupper: Administrative documentation, Demography, Vital Signs, Cervix carcinoma, Medical History, Cervix carcinoma, Operative Surgical Procedures, Previous, Cervix carcinoma, Chemotherapy Regimen, Previous, Cervix carnoma, Biological Therapy; Cervix carcinoma, Immunotherapy, Cervix carcinoma, Therapeutic radiology procedure, Cervix carcinoma, Therapeutic procedures, Drug toxicity, 12 lead ECG, Cervix carcinoma, Tumor Results Assessment Test, Cervix carcinoma, Condition, Associated, Medical History; History of surgical procedures; Physical Examination, Concomitant Agent; Prior Medication Usage, Inclusion, Exclusion Criteria, Eligibility Determination, Randomization, Telephone
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 - Screening

- 2019-07-05 - 1 Formulär, 18 Item-grupper, 96 Dataelement, 1 Språk
Item-grupper: Administrative documentation, Demography, Vital Signs, Cervix carcinoma, Medical History, Cervix carcinoma, Operative Surgical Procedures, Previous, Cervix carcinoma, Chemotherapy Regimen, Previous, Cervix carnoma, Biological Therapy; Cervix carcinoma, Immunotherapy, Cervix carcinoma, Therapeutic radiology procedure, Cervix carcinoma, Therapeutic procedures, Drug toxicity, 12 lead ECG, Cervix carcinoma, Tumor Results Assessment Test, Cervix carcinoma, Condition, Associated, Medical History; History of surgical procedures; Physical Examination, Concomitant Agent; Prior Medication Usage, Inclusion, Exclusion Criteria, Eligibility Determination, Randomization, Telephone
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

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