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

- 2018-05-16 - 1 Formulär, 12 Item-grupper, 54 Dataelement, 1 Språk

Item-grupper: 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

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

Effects of Esomeprazole on Lapatinib in Subjects with Breast Cancer; 109275 - Logs/Repeats

- 2020-08-13 - 1 Formulär, 10 Item-grupper, 157 Dataelement, 1 Språk

Item-grupper: Event Log, Repeat, Echocardiography, Multiple gated acquisition scanning, Vital signs, Repeat, 12 lead ECG, Unscheduled, Repeat, 12 lead ECG, Abnormality, Pharmacokinetic aspects, Unscheduled, Repeat, Experimental drug, Unscheduled, Repeat, Adverse event, Repeat, Serious Adverse Event, Concomitant Agent, Repeat

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

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

- 2020-06-25 - 1 Formulär, 10 Item-grupper, 187 Dataelement, 1 Språk

Item-grupper: Date of visit, Vital signs, 12 lead ECG, 12 lead ECG, Abnormality, Experimental drug, Continuation status, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Hematology finding, Conclusion, Clinical Research, Cessation of life, Pregnancy, Information

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

Effects of Esomeprazole on Lapatinib in Subjects with Breast Cancer; 109275 - Period 2 Visit

- 2020-06-25 - 1 Formulär, 8 Item-grupper, 288 Dataelement, 1 Språk

Item-grupper: Date of visit, Vital signs, 12 lead ECG, 12 lead ECG, Abnormality, Pharmacokinetic aspects, Experimental drug, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Hematology finding

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

Effects of Esomeprazole on Lapatinib in Subjects with Breast Cancer; 109275 - Period 1 Visit

- 2020-06-25 - 1 Formulär, 9 Item-grupper, 298 Dataelement, 1 Språk

Item-grupper: Date of visit, Vital signs, 12 lead ECG, 12 lead ECG, Abnormality, Pharmacokinetic aspects, Experimental drug, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Hematology finding, CYP2C19 gene, Genotype

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

Effects of Esomeprazole on Lapatinib in Subjects with Breast Cancer; 109275 - Day 1

- 2020-06-15 - 1 Formulär, 7 Item-grupper, 180 Dataelement, 1 Språk

Item-grupper: Date of visit, Vital signs, 12 lead ECG, 12 lead ECG, Abnormality, Randomisation, Numbers, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Hematology finding

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

Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886 - Post RT/Prior to Surgery

- 2019-08-19 - 1 Formulär, 4 Item-grupper, 14 Dataelement, 1 Språk

Item-grupper: Administrative documentation, Serious Adverse Event, 12 lead ECG, Experimental drug, Compliance behavior

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 - 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

Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer NCT00549328 - Week 36 - Vital Signs; Local Laboratory - Haematology, Clinical Chemistry; Liver Assessment; Laboratory - Thyroid Function Test; Urinalysis; Urinalysis - Local: 24h Protein Details; Target Lesion Assessments; Confirmatory Response; Investigational Product Compliance - Pazopanib, 12-Lead ECG

- 2019-05-22 - 1 Formulär, 13 Item-grupper, 188 Dataelement, 1 Språk

Item-grupper: Date of visit/ assessment, Vital Signs, Local Laboratory - Haematology, Local Laboratory - Clinical Chemistry, Liver Assessment, Local Laboratory - Thyroid Function, Local Laboratory - Urinalysis, Urinalysis - Local: 24 hour Protein Details, Target Lesion Summary, Confirmatory Response - Response Summary, Confirmatory Response - New Lesions, Investigatoinal Product Compliance - Pazopanib, 12-Lead ECG

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 Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GW786034 Trade Name: Drug: Pazopanib Study Indication: Lung Cancer, Non-Small Cell

Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer NCT00549328 - Week 12 - Vital Signs; Local Laboratory - Haematology, Clinical Chemistry; Liver Assessment; Laboratory - Thyroid Function Test; Urinalysis; Urinalysis - Local: 24h Protein Details; Target Lesion Assessments; Confirmatory Response; Investigational Product Compliance - Pazopanib, 12-Lead ECG

- 2019-05-21 - 1 Formulär, 13 Item-grupper, 188 Dataelement, 1 Språk