Search results - Portal of Medical Data Models (MDM-Portal)

Cognitive/Functional Effects NCT01372774 Eligibility - N107C Pre-Registration (Step 1) Form and Eligibility Checklist - 3226376v1.0 - N107C Pre-Registration (Step 1) Form and Eligibility Checklist

- 9/20/21 - 1 form, 4 itemgroups, 45 items, 1 language

Itemgroups: Pre-Registration Inclusion Criteria - All responses in this section below must be "Yes.",Pre-Registration Exclusion Criteria,Registration Check,Randomization Check (continued) - All responses in section below may be "Yes" or "No."

N107C Pre-Registration (Step 1) Form and Eligibility Checklist Stereotactic Radiosurgery or Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases That Have Been Removed By Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A06D80B4-4143-B9BC-E040-BB89AD437EB8

Cognitive/Functional Effects NCT01279681 Eligibility - N0949 Registration Form and Eligibility Checklist - 3143440v1.0 - N0949 Registration Form and Eligibility Checklist

- 9/20/21 - 1 form, 5 itemgroups, 80 items, 1 language

Itemgroups: Inclusion Criteria - All responses in this section below must be "Yes.",Exclusion Criteria - All responses in section below must be "No.",Randomization Check,Randomized Check (continued) - All responses in section below may be "Yes" or "No".,Stratification Factors (used fo randomization to Arms A-B)

N0949 Registration Form and Eligibility Checklist Combination Chemotherapy Plus Bevacizumab With or Without Oxaliplatin in Treating Older Patients With Metastatic Colorectal Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9156A820-0337-BDA0-E040-BB89AD435144

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

- 4/26/21 - 1 form, 9 itemgroups, 117 items, 1 language

Itemgroups: Date of visit, Assessment Date,Event Log, Status,Non-serious Adverse Event,Serious Adverse Event,Concomitant Agent,Concomitant Agent, Adrenal Cortex Hormones,Blood product; Supportive care,Collection of blood specimen for laboratory procedure, Pharmacogenetic Test, Informed Consent,Pharmacogenetic Test, Informed Consent, Withdraw (activity)

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

Lapatinib + Topotecan or + Capecitabine in Recurrent Brain Metastases from Breast Cancer; NCT00437073 - Cycle 1 - Week 4

- 10/13/20 - 1 form, 9 itemgroups, 163 items, 1 language

Itemgroups: Date of visit, Assessment Date,Neurologic Examination,Neurologic Symptoms, Associated with, Neoplasms,Laboratory Procedures, Central Laboratory; Laboratory Procedures, Local,Laboratory Procedures, Chemistry, Clinical,Laboratory Procedures, Hematology finding,Central Laboratory, Data,Vital signs,Continuation status, Study

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

Lapatinib + Topotecan or + Capecitabine in Recurrent Brain Metastases from Breast Cancer; NCT00437073 - Cycle 1 - Day 15

- 10/13/20 - 1 form, 11 itemgroups, 157 items, 1 language

Itemgroups: Date of visit, Assessment Date,Laboratory Procedures, Central Laboratory; Laboratory Procedures, Local,Laboratory Procedures, Chemistry, Clinical,Laboratory Procedures, Hematology finding,Central Laboratory, Data,Disease, Operative Surgical Procedures,Vital signs,Experimental drug, Topotecan, Dosage,Therapeutic procedure, Confirmation,Lapatinib, Compliance behavior,Continuation status, Study

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

Lapatinib + Topotecan or + Capecitabine in Recurrent Brain Metastases from Breast Cancer; NCT00437073 - Cycle 1 - Day 8

- 10/13/20 - 1 form, 10 itemgroups, 154 items, 1 language

Itemgroups: Date of visit, Assessment Date,Laboratory Procedures, Central Laboratory; Laboratory Procedures, Local,Laboratory Procedures, Chemistry, Clinical,Laboratory Procedures, Hematology finding,Central Laboratory, Data,Vital signs,Experimental drug, Topotecan, Dosage,Therapeutic procedure, Confirmation,Lapatinib, Compliance behavior,Continuation status, Study

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

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

- 10/13/20 - 1 form, 4 itemgroups, 9 items, 1 language

Itemgroups: Date of visit, Assessment Date,Cessation of life,Pregnancy, Information,Conclusion, Clinical Research

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

Lapatinib + Topotecan or + Capecitabine in Recurrent Brain Metastases from Breast Cancer; NCT00437073 - Cycle 1 - Day 1

- 10/13/20 - 1 form, 12 itemgroups, 168 items, 1 language

Itemgroups: Date of visit, Assessment Date,Visit, Previous,Laboratory Procedures, Central Laboratory; Laboratory Procedures, Local,Laboratory Procedures, Chemistry, Clinical,Laboratory Procedures, Hematology finding,Central Laboratory, Data,Vital signs,Experimental drug, Lapatinib,Experimental drug, Topotecan, Dosage,Therapeutic procedure, Confirmation,Lapatinib, Compliance behavior,Continuation status, Study

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

Lapatinib + Topotecan or + Capecitabine in Recurrent Brain Metastases from Breast Cancer; NCT00437073 - Survival Follow-Up

- 10/13/20 - 1 form, 2 itemgroups, 5 items, 1 language

Itemgroups: Date of visit, Assessment Date,follow-up, Continuance of life

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

Lapatinib + Topotecan or + Capecitabine in Recurrent Brain Metastases from Breast Cancer; NCT00437073 - Day 1 Predose

- 10/13/20 - 1 form, 6 itemgroups, 40 items, 1 language

Itemgroups: Date of visit, Assessment Date,Neurologic Examination,Neurologic Symptoms, Associated with, Neoplasms,Vital signs,Randomization, Numbers,Therapeutic regimen

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

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

- 8/13/20 - 1 form, 3 itemgroups, 7 items, 1 language

Itemgroups: Date of visit, Assessment Date,Laboratory, Local,Laboratory, Local

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

On-Study - Metastatic Brain Cancer - On-Study Form - 2287553v3.0 - Metastatic Brain Cancer - On-Study Form

- 1/9/15 - 1 form, 10 itemgroups, 64 items, 1 language

Itemgroups: CRF Header,Brain: Form Administration,Non-CNS: Initial Disease Description,Brain: Current Disease Description,Brain: Concomitant Medications,Metastatic Brain: Prior Health History,Metastatic Brain: Prior Treatment,Brain: Prior Treatment - Systemic Regimens,Brain: Prior Treatment - CNS RT,Brain: Prior Treatment - CNS Surgery

Metastatic Brain Cancer - On-Study Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=EF3A8ACE-5457-4C56-E034-0003BA3F9857

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