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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 - 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 - 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

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

Bioavailability of an investigational drug compared to Coreg IR in healthy adults GSK104257 - Unscheduled Visit

- 4/16/18 - 1 form, 3 itemgroups, 27 items, 1 language
Itemgroups: Vital signs, 12-lead ECG, Lab Data
Study ID: 104257 Clinical Study ID: CRV104257 Study Title: A randomized, open-label, two period, period balanced, crossover study to estimate the relative bioavailability of an investigational drug compared to Coreg IR in healthy adult volunteers 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension Documentation part: Unscheduled Visit

Bioavailability of an investigational drug compared to Coreg IR in healthy adults GSK104257 - Screening

- 4/16/18 - 1 form, 5 itemgroups, 59 items, 1 language
Itemgroups: Eligibility Question, Demography, Vital signs, 12-lead ECG, Lab Data
Study ID: 104257 Clinical Study ID: CRV104257 Study Title: A randomized, open-label, two period, period balanced, crossover study to estimate the relative bioavailability of an investigational drug compared to Coreg IR in healthy adult volunteers 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension Documentation part: Screening

Bioavailability of an investigational drug compared to Coreg IR in healthy adults GSK104257 - Study Conclusion

- 4/4/18 - 1 form, 2 itemgroups, 9 items, 1 language
Itemgroups: Study Conclusion, Pregnancy
Study ID: 104257 Clinical Study ID: CRV104257 Study Title: A randomized, open-label, two period, period balanced, crossover study to estimate the relative bioavailability of an investigational drug compared to Coreg IR in healthy adult volunteers 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension Documentation part: Study Conclusion

Bioavailability of an investigational drug compared to Coreg IR in healthy adults GSK104257 - Concomitant Medications

- 4/4/18 - 1 form, 1 itemgroup, 14 items, 1 language
Itemgroup: Concomitant Medications
Study ID: 104257 Clinical Study ID: CRV104257 Study Title: A randomized, open-label, two period, period balanced, crossover study to estimate the relative bioavailability of an investigational drug compared to Coreg IR in healthy adult volunteers 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension Documentation part: Concomitant Medications

Bioavailability of an investigational drug compared to Coreg IR in healthy adults GSK104257 - Serious Adverse Event

- 4/4/18 - 1 form, 5 itemgroups, 44 items, 1 language
Itemgroups: Serious Adverse Event, Demography Data, Relevant medical conditions/Risk factors, Relevant concomitant medications, Details of Investigational Product(s)
Study ID: 104257 Clinical Study ID: CRV104257 Study Title: A randomized, open-label, two period, period balanced, crossover study to estimate the relative bioavailability of an investigational drug compared to Coreg IR in healthy adult volunteers 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension Documentation part: Serious Adverse Event

Bioavailability of an investigational drug compared to Coreg IR in healthy adults GSK104257 - Non-Serious Adverse Event

- 4/4/18 - 1 form, 1 itemgroup, 12 items, 1 language
Itemgroup: Non-Serious Adverse Events
Study ID: 104257 Clinical Study ID: CRV104257 Study Title: A randomized, open-label, two period, period balanced, crossover study to estimate the relative bioavailability of an investigational drug compared to Coreg IR in healthy adult volunteers 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension Documentation part: Non-Serious Adverse Event

Bioavailability of an investigational drug compared to Coreg IR in healthy adults GSK104257 - Period 2

- 4/16/18 - 1 form, 6 itemgroups, 36 items, 1 language
Itemgroups: Investigational Product, Pharmacokinetics - Blood, Vital signs, 12-lead ECG, Lab Data, Pregnancy Test
Study ID: 104257 Clinical Study ID: CRV104257 Study Title: A randomized, open-label, two period, period balanced, crossover study to estimate the relative bioavailability of an investigational drug compared to Coreg IR in healthy adult volunteers 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension Documentation part: Period 2

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