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Oral GW786034 treatment for ovarian cancer NCT00281632 - Additional Forms

- 03.06.18 - 1 Formular, 24 Itemgruppen, 95 Datenelemente, 1 Sprache

Itemgruppen: Header, investigational product discontinuation, PGx-Pharmacogenetic Research, Concomitant Medications, If Yes to Concominant Medication, Non-serious adverse events, Non-serious adverse events, Serious adverse event, Serious adverse events description, Seriousness, Document section Demography data, SECTION 4, Section 5, Relevant Medical Conditions, Document section Risk factors, Document section Concomitant Medications, Drug Details, Assessments, Document section, Pregnancy information, Death, Study Conclusion, Investigator comment log, Investigators Signature

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 - Follow-up

- 25.06.20 - 1 Formular, 10 Itemgruppen, 187 Datenelemente, 1 Sprache

Itemgruppen: 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

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

- 12.07.19 - 1 Formular, 2 Itemgruppen, 5 Datenelemente, 1 Sprache

Itemgruppen: Administrative documentation, Conclusion, Clinical Research

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

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

- 20.08.19 - 1 Formular, 3 Itemgruppen, 10 Datenelemente, 1 Sprache

Itemgruppen: Administrative documentation, Clinical Trials, Conclusion, Investigator Signature

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

CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 End of Treatment - CRFs Cabazitaxel Prostate Cancer NCT01308580 End of Treatment

- 25.05.17 - 1 Formular, 7 Itemgruppen, 46 Datenelemente, 1 Sprache

Itemgruppen: End of Treatment, Visit Information, Vital Signs, Laboratory Tests Hematology, Laboratory Tests Biochemistry, Ciruclating free plasma DNA - Blood Sampling, Electrocardiogram

Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/m² and at 25 mg/m² Every 3 Weeks in Combination With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen Other drug name: Jevtana® Study Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT01308580 Sponsor: Sanofi

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

- 13.10.20 - 1 Formular, 4 Itemgruppen, 9 Datenelemente, 1 Sprache

Itemgruppen: 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

Cytoreductive Surgery (CRS) With/Without HIPEC in Gastric Cancer With Peritoneal Carcinomatosis (GASTRIPEC) - Studienende

- 20.11.17 - 1 Formular, 3 Itemgruppen, 15 Datenelemente, 1 Sprache

Itemgruppen: Administrative Documentation, End of study, Administrative Documentation

Prospective Multicenter Phase III Trial Using CRS With / Without HIPEC After Preoperative Chemotherapy in Patients With Peritoneal Carcinomatosis of Gastric Cancer Incl. Adenocarcinoma of the Esophagogastric Junction NCT-Identifier: NCT02158988 Source: Prof. Dr. med. Beate Rau, MBA Charité Universitätsmedizin Berlin Studienende Bitte füllen Sie diesen Bogen nur bei Studienende aus! Bitte faxen Sie diese Seite umgehend an die Studienzentrale Charité: 030 – 450 7 522 214 Hinweis: Ab dem oben angegebenen Datum ist keine weitere Dokumentation mehr erforderlich.

Cytoreductive Surgery (CRS) With/Without HIPEC in Gastric Cancer With Peritoneal Carcinomatosis (GASTRIPEC) - Abbruch Studientherapie

- 20.11.17 - 1 Formular, 4 Itemgruppen, 11 Datenelemente, 1 Sprache

Itemgruppen: Administrative Documentation, Study withdrawal, Study withdrawal, Administrative Documentation

Prospective Multicenter Phase III Trial Using CRS With / Without HIPEC After Preoperative Chemotherapy in Patients With Peritoneal Carcinomatosis of Gastric Cancer Incl. Adenocarcinoma of the Esophagogastric Junction NCT-Identifier: NCT02158988 Source: Prof. Dr. med. Beate Rau, MBA Charité Universitätsmedizin Berlin Bitte füllen Sie diesen Bogen nur bei Abbruch der Studientherapie aus! HINWEIS: Die Dokumentation wird weitergeführt , außer bei Rücknahme der Einwilligung. Dies ist erforderlich für die Intent to Treat Analyse. Bitte faxen Sie diese Seite umgehend an das Studienzentrale der Charité: 030 – 450 7 522 214

XELODA and Lapatinib Advanced or Metastatic Breast Cancer Withdrawal / Study Conclusion NCT00078572

- 18.05.17 - 1 Formular, 9 Itemgruppen, 77 Datenelemente, 1 Sprache

Itemgruppen: Withdrawal / Study Conclusion, Physical Exam (Vital Signs, Weight, Height), ECOG Performance Status, Cardiac Assessments Screening, Hematology, Clinical Chemistry, Response Assessment, Confirmatory Scan, Endpoint Evaluation : Investigator

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: Withdrawal / Study Conclusion 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

Topotecan (HycamtinTM) with Carboplatin as First-Line Chemotherapy in Patients with Ovarian Cancer; 104864/612 - Study End

- 13.08.19 - 1 Formular, 3 Itemgruppen, 8 Datenelemente, 1 Sprache

Itemgruppen: Administrative documentation, Clinical Research, End, Investigator Signature, Confirmation

Study ID: 104864/612 Clinical Study ID: 104864/612 Study Title: A Prospective, Open Label Phase II Study to Evaluate the Efficacy and Safety of Topotecan (HycamtinTM) in Combination with Carboplatin as First-line Chemotherapy in Patients with Ovarian 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: HycamtinTM Study Indication: Ovarian Cancer

Effects of Low-fat and high-fat meals on the Pharmacokinetics of Lapatinib in ErB2+ Breast Cancer patients, NCT00821054 - End of Study

- 20.07.20 - 1 Formular, 5 Itemgruppen, 16 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, Study Conclusion, Death, Pregnancy information, Pregnancy Information, males

Study ID: 111582 Clinical Study ID: 111582 Study Title: An Open Label Study to Examine the Effects of Low-fat and High-fat Meals on the Pharmacokinetics of Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00821054 https://clinicaltrials.gov/ct2/show/NCT00821054 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib Trade Name: N/A Study Indication: Neoplasms, Breast The study consists of a screening, four study visits at day-1, week 1, 2 and 3 and a follow-up visit. This document contains the end of study document within the Study conclusion, death and pregnancy information. It has to be filled in for the Follow-up visit.

Radium-223 Dichloride (Alpharadin) DRKS00006460 NCT01618370 in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases (Last Visit) - Radium 223 Dichloride (Alpharadin) - Last Visit

- 30.03.17 - 1 Formular, 2 Itemgruppen, 4 Datenelemente, 1 Sprache

Itemgruppen: Last Visit, Death

This study is a prospective, interventional, open-label, multi-center early access program for the use of Ra-223 Cl2 in HRPC/CRPC (Hormone refractory prostate cancer / Castrate resistant prostate cancer) patients diagnosed with bone metastasis and to collect additional short and long term safety data on the product. NCT01618370

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