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Predictors of Therapeutic Response in Ovarian Carcinoma NCT01391351 - Eligibility Criteria

- 23/06/19 - 1 modulo, 2 itemgroups, 13 elementi, 1 linguaggio
Itemgroups: Inclusion Criteria, Exclusion Criteria
Search for Predictors of Therapeutic Response in Ovarian Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01391351 In order to search for predictors of response to chemotherapy in patients with ovarian carcinoma of the ovary, the fallopian tube or peritoneal serous-type advanced stage, we will define the comparative profiles of miRNA expression of serum polymorphisms and determine differential in 2 patient populations (with or without recurrence 6 months after completion of chemotherapy) with (i) the miRNA profile of serum before treatment and (ii) identification of polymorphisms or SNP (Single Nucleotide Polymorphism) in particular genes involved in the metabolism of chemotherapy agents In the case of miRNA, expression profiles will also be studied during the first course in response to chemotherapy. Indeed, the miRNA profile of serum may be different at baseline among the 2 types of populations (or non-recurrence at 6 months).

PRIOR TREATMENT FOR BREAST CANCER (ADJUVANT SETTING) Roche H0650g Breast Cancer - PRIOR TREATMENT FOR BREAST CANCER (ADJUVANT SETTING)

- 15/03/21 - 1 modulo, 3 itemgroups, 18 elementi, 1 linguaggio
Itemgroups: Chemotherapy, Therapeutic regimen, ADJUVANT THERAPY
Study part: Prior treatment for breast cancer (Adjuvant setting). A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche"

Oral Topotecan Daily x 5 Days vs. Oral Topotacan 5 Days On, 2 Days Off; 104864/502 - Study Medication Daily X5 Days Regimen

- 05/07/19 - 1 modulo, 3 itemgroups, 14 elementi, 1 linguaggio
Itemgroups: Administrative documentation, Body Weight, Body Surface Area, Topotecan, Chemotherapy Regimen
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 - Study Medication 5 Days On, 2 Days Off for 3 Weeks Regimen

- 05/07/19 - 1 modulo, 6 itemgroups, 21 elementi, 1 linguaggio
Itemgroups: Administrative documentation, Body Weight, Topotecan, Chemotherapy Regimen, Topotecan, Chemotherapy Regimen, Topotecan, Chemotherapy Regimen, Topotecan, Chemotherapy Regimen, Dose Reduced
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 - Study Medication 5 Days On, 2 Days Off for 3 Weeks Regimen

- 05/07/19 - 1 modulo, 5 itemgroups, 18 elementi, 1 linguaggio
Itemgroups: Administrative documentation, Body Weight, Topotecan, Chemotherapy Regimen, Topotecan, Chemotherapy Regimen, Topotecan, Chemotherapy Regimen
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 - Oral Topotecan Daily X5 Days Regimen

- 05/07/19 - 1 modulo, 3 itemgroups, 11 elementi, 1 linguaggio
Itemgroups: Administrative documentation, Body Weight, Body Surface Area, Topotecan, Chemotherapy Regimen
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 - Prenext Course Visit

- 08/07/19 - 1 modulo, 8 itemgroups, 26 elementi, 1 linguaggio
Itemgroups: Administrative documentation, Topotecan, Chemotherapy Regimen, Serious Adverse Event, Vital Signs, 12 lead ECG, Topotecan, Chemotherapy Regimen, Topotecan, Chometherapy Regimen, Topotecan, Chemotherapy Regimen, Topotecan, Chemotherapy Regimen
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 - Prenext Course Visit

- 08/07/19 - 1 modulo, 11 itemgroups, 38 elementi, 1 linguaggio
Itemgroups: Administrative documentation, Topotecan, Chemotherapy Regimen, Serious Adverse Event, Topotecan, Chemotherapy Regimen, Topotecan, Chemotherapy Regimen, Topotecan, Chemotherapy Regimen, Vital Signs, 12 lead ECG, Topotecan, Chemotherapy Regimen, Topotecan, Chometherapy Regimen, Topotecan, Chemotherapy Regimen, Topotecan, Chemotherapy Regimen
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

Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308 - Screening - Prior Ovarian Cancer Treatment; Laboratory Tests; Lesion Assessment Record

- 23/08/19 - 1 modulo, 13 itemgroups, 48 elementi, 1 linguaggio
Itemgroups: Administrative, Prior Ovarian Cancer Treatment - Chemotherapy, Has the patient received radiotherapy?, Prior Ovarian Cancer Treatment - Radiotherapy , Has the patient received prior cancer-related surgery?, Prior Ovarian Cancer Treatment - Surgical Treatment , Has the patient received other cancer-related treatments?, Other Cancer Related Treatments, Laboratory Tests (within 7 days prior to Day 1) - Haematology, Laboratory Tests (within 7 days prior to Day 1) - Haematology , Laboratory Tests (within 7 days prior to Day 1) - Chemistry, Laboratory Tests (within 7 days prior to Day 1) - Chemistry , Lesion Assessment Record
Study ID: 104864/627 Clinical Study ID: 104864/627 Study Title: An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00061308 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan, Gemcitabine Study Indication: Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer

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