Attachment 127530 Details for Bug 102337 – XML file from WHO clinical trials registry

XML file from WHO clinical trials registry

ICTRP-Results.xml (text/xml), 21.01 KB, created by la .myrf. on 2016-09-21 20:32:28 UTC

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Creator: la .myrf.

Created: 2016-09-21 20:32:28 UTC

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><?xml version='1.0' encoding='UTF-8" ?><Trials_downloaded_from_ICTRP>
>  <Trial>
>    <TrialID>EUCTR2005-006024-11-DE</TrialID>
>    <Last_Refreshed_on>19 March 2012</Last_Refreshed_on>
>    <Public_title>Prospective, open label, multi center phase II clinical trial of oral BAY 43-9006 (Sorafenib) in patients with relapsed or refractory multiple myeloma - not applicable</Public_title>
>    <Scientific_title>Prospective, open label, multi center phase II clinical trial of oral BAY 43-9006 (Sorafenib) in patients with relapsed or refractory multiple myeloma - not applicable                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         </Scientific_title>
>    <Primary_sponsor>University hospital of Bonn</Primary_sponsor>
>    <Date_registration>14/07/2006</Date_registration>
>    <Export_date>9/21/2016 10:21:51 PM</Export_date>
>    <Source_Register>EU Clinical Trials Register</Source_Register>
>    <web_address>https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-006024-11                                                                                                                                                                    </web_address>
>    <Recruitment_Status>Not Recruiting</Recruitment_Status>
>    <other_records>No</other_records>
>    <Inclusion_agemin />
>    <Inclusion_agemax />
>    <Inclusion_gender>&lt;br&gt;Female: yes&lt;br&gt;Male: yes&lt;br&gt;</Inclusion_gender>
>    <Date_enrollement>08/11/2006</Date_enrollement>
>    <Target_size />
>    <Study_type>Interventional clinical trial of medicinal product</Study_type>
>    <Study_design>Controlled: yes
>Randomised: no
>Open: yes
>Single blind: no
>Double blind: no
>Parallel group: no
>Cross over: no
>Other: no
>If controlled, specify comparator, Other Medicinial Product: no
>Placebo: no
>Other: no
></Study_design>
>    <Countries>Germany</Countries>
>    <Contact_Firstname />
>    <Contact_Lastname />
>    <Contact_Address />
>    <Contact_Email />
>    <Contact_Tel />
>    <Contact_Affiliation />
>    <Condition>Relapsed or refractory multiple myeloma</Condition>
>    <Intervention>&lt;br&gt;Product Name: Sorafenib&lt;br&gt;Pharmaceutical Form: Tablet&lt;br&gt;&lt;br&gt;</Intervention>
>    <Primary_outcome>Main Objective: Primary aim is to demonstrate that Sorafenib is active in patients with multiple myeloma in relapse or recurrent disease as a first evaluation of the effectiveness of this novel agent in the field of multiple myeloma.;Secondary Objective: To evaluate specific toxicity, safety, tolerability and response rates, duration of response as well as accompanying scientific topics like changes in blood vessel density and the prediction of clinical outcome and response to treatment by global gene expression profiling (GEP).;Primary end point(s): Evaluation of progression free survival (PFS)</Primary_outcome>
>    <Secondary_ID>HD/BN-2005-MM-R;not applicable</Secondary_ID>
>  </Trial>
>  <Trial>
>    <TrialID>NCT00118170</TrialID>
>    <Last_Refreshed_on>19 February 2015</Last_Refreshed_on>
>    <Public_title>Sorafenib in Treating Patients With Metastatic or Unresectable Solid Tumors, Multiple Myeloma, or Non-Hodgkin's Lymphoma With or Without Impaired Liver or Kidney Function</Public_title>
>    <Scientific_title>Pharmacokinetic and Phase I Study of Sorafenib (BAY 43-9006, NSC 724772, IND 69896) for Solid Tumors and Hematologic Malignancies in Patients With Hepatic or Renal Dysfunction</Scientific_title>
>    <Acronym />
>    <Primary_sponsor>National Cancer Institute (NCI)</Primary_sponsor>
>    <Date_registration>08/07/2005</Date_registration>
>    <Export_date>9/21/2016 10:21:51 PM</Export_date>
>    <Source_Register>ClinicalTrials.gov</Source_Register>
>    <web_address>http://clinicaltrials.gov/show/NCT00118170</web_address>
>    <Recruitment_Status>Not recruiting</Recruitment_Status>
>    <other_records>No</other_records>
>    <Inclusion_agemin>18 Years</Inclusion_agemin>
>    <Inclusion_agemax>N/A</Inclusion_agemax>
>    <Inclusion_gender>Both</Inclusion_gender>
>    <Date_enrollement>October 2004</Date_enrollement>
>    <Target_size>150</Target_size>
>    <Study_type>Interventional</Study_type>
>    <Study_design>Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment</Study_design>
>    <Phase>Phase 1</Phase>
>    <Countries>United States</Countries>
>    <Contact_Firstname xml:space="preserve"> </Contact_Firstname>
>    <Contact_Lastname>Antonius Miller</Contact_Lastname>
>    <Contact_Email />
>    <Contact_Tel />
>    <Contact_Affiliation>Cancer and Leukemia Group B</Contact_Affiliation>
>    <Condition>Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue;Nodal Marginal Zone B-cell Lymphoma;Recurrent Adult Burkitt Lymphoma;Recurrent Adult Diffuse Large Cell Lymphoma;Recurrent Adult Diffuse Mixed Cell Lymphoma;Recurrent Adult Diffuse Small Cleaved Cell Lymphoma;Recurrent Adult Grade III Lymphomatoid Granulomatosis;Recurrent Adult Immunoblastic Large Cell Lymphoma;Recurrent Adult Lymphoblastic Lymphoma;Recurrent Grade 1 Follicular Lymphoma;Recurrent Grade 2 Follicular Lymphoma;Recurrent Grade 3 Follicular Lymphoma;Recurrent Mantle Cell Lymphoma;Recurrent Marginal Zone Lymphoma;Recurrent Small Lymphocytic Lymphoma;Refractory Multiple Myeloma;Splenic Marginal Zone Lymphoma;Stage II Multiple Myeloma;Stage III Adult Burkitt Lymphoma;Stage III Adult Diffuse Large Cell Lymphoma;Stage III Adult Diffuse Mixed Cell Lymphoma;Stage III Adult Diffuse Small Cleaved Cell Lymphoma;Stage III Adult Immunoblastic Large Cell Lymphoma;Stage III Adult Lymphoblastic Lymphoma;Stage III Grade 1 Follicular Lymphoma;Stage III Grade 2 Follicular Lymphoma;Stage III Grade 3 Follicular Lymphoma;Stage III Mantle Cell Lymphoma;Stage III Marginal Zone Lymphoma;Stage III Multiple Myeloma;Stage III Small Lymphocytic Lymphoma;Stage IV Adult Burkitt Lymphoma;Stage IV Adult Diffuse Large Cell Lymphoma;Stage IV Adult Diffuse Mixed Cell Lymphoma;Stage IV Adult Diffuse Small Cleaved Cell Lymphoma;Stage IV Adult Immunoblastic Large Cell Lymphoma;Stage IV Adult Lymphoblastic Lymphoma;Stage IV Grade 1 Follicular Lymphoma;Stage IV Grade 2 Follicular Lymphoma;Stage IV Grade 3 Follicular Lymphoma;Stage IV Mantle Cell Lymphoma;Stage IV Marginal Zone Lymphoma;Stage IV Small Lymphocytic Lymphoma;Unspecified Adult Solid Tumor, Protocol Specific;WaldenstrÃ¶m Macroglobulinemia</Condition>
>    <Intervention>Drug: sorafenib tosylate;Other: pharmacological study</Intervention>
>    <Primary_outcome>Relationship between the pharmacokinetics and measures of renal dysfunction categorized by creatinine clearance as estimated by the Cockcroft and Gault formula (Part 1);Severity of hepatic disease as assessed by the Child-Pugh criteria;Distribution of and association patterns between the Child-Pugh score and that of patient's risk of toxicity beyond each dose or cohort, assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0;Mean levels of area under the curve (AUC) using the ANOVA model;Maximum tolerated dose (MTD) of sorafenib tosylate, assessed using the NCI CTCAE v3.0 (Part 2);Dose-limiting toxicities (DLT), defined as any grade 3 or greater non-hematologic toxicity, assessed using the NCI CTCAE v3.0</Primary_outcome>
>    <Secondary_ID>CALGB-60301;U10CA031946;CDR0000433342;NCI-2012-03083</Secondary_ID>
>    <Source_Support>Please refer to primary and secondary sponsors</Source_Support>
>  </Trial>
>  <Trial>
>    <TrialID>NCT00253578</TrialID>
>    <Last_Refreshed_on>19 February 2015</Last_Refreshed_on>
>    <Public_title>Sorafenib in Treating Patients With Relapsed or Refractory Multiple Myeloma</Public_title>
>    <Scientific_title>A Phase II Trial of BAY 43-9006 (Sorafenib) (NSC-724772) in Patients With Relapsing or Resistant Multiple Myeloma</Scientific_title>
>    <Acronym />
>    <Primary_sponsor>National Cancer Institute (NCI)</Primary_sponsor>
>    <Date_registration>11/11/2005</Date_registration>
>    <Export_date>9/21/2016 10:21:51 PM</Export_date>
>    <Source_Register>ClinicalTrials.gov</Source_Register>
>    <web_address>http://clinicaltrials.gov/show/NCT00253578</web_address>
>    <Recruitment_Status>Not recruiting</Recruitment_Status>
>    <other_records>No</other_records>
>    <Inclusion_agemin>18 Years</Inclusion_agemin>
>    <Inclusion_agemax>N/A</Inclusion_agemax>
>    <Inclusion_gender>Both</Inclusion_gender>
>    <Date_enrollement>March 2006</Date_enrollement>
>    <Target_size>40</Target_size>
>    <Study_type>Interventional</Study_type>
>    <Study_design>Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment</Study_design>
>    <Phase>Phase 2</Phase>
>    <Countries>United States</Countries>
>    <Contact_Firstname xml:space="preserve"> </Contact_Firstname>
>    <Contact_Lastname>Mohamad Hussein</Contact_Lastname>
>    <Contact_Email />
>    <Contact_Tel />
>    <Contact_Affiliation>Southwest Oncology Group</Contact_Affiliation>
>    <Condition>Refractory Multiple Myeloma</Condition>
>    <Intervention>Drug: sorafenib tosylate;Other: laboratory biomarker analysis</Intervention>
>    <Primary_outcome>Overall response rate (confirmed CR, R and PR);Incidence of qualitative and quantitative toxicities associated with this regimen;Overall survival;Progression-free survival</Primary_outcome>
>    <Secondary_ID>S0434;U10CA032102;CDR0000449973;NCI-2012-03064</Secondary_ID>
>    <Source_Support>Please refer to primary and secondary sponsors</Source_Support>
>  </Trial>
>  <Trial>
>    <TrialID>NCT00303797</TrialID>
>    <Last_Refreshed_on>19 February 2015</Last_Refreshed_on>
>    <Public_title>Sorafenib and Bortezomib in Treating Patients With Advanced Cancer</Public_title>
>    <Scientific_title>A Phase I Study of the Raf Kinase/VEGFR Inhibitor BAY 43-9006 in Combination With the Proteasome Inhibitor PS-341 in Patients With Advanced Malignancies</Scientific_title>
>    <Acronym />
>    <Primary_sponsor>National Cancer Institute (NCI)</Primary_sponsor>
>    <Date_registration>15/03/2006</Date_registration>
>    <Export_date>9/21/2016 10:21:51 PM</Export_date>
>    <Source_Register>ClinicalTrials.gov</Source_Register>
>    <web_address>http://clinicaltrials.gov/show/NCT00303797</web_address>
>    <Recruitment_Status>Not recruiting</Recruitment_Status>
>    <other_records>No</other_records>
>    <Inclusion_agemin>18 Years</Inclusion_agemin>
>    <Inclusion_agemax>N/A</Inclusion_agemax>
>    <Inclusion_gender>Both</Inclusion_gender>
>    <Date_enrollement>December 2005</Date_enrollement>
>    <Target_size>50</Target_size>
>    <Study_type>Interventional</Study_type>
>    <Study_design>Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment</Study_design>
>    <Phase>Phase 1</Phase>
>    <Countries>United States</Countries>
>    <Contact_Firstname xml:space="preserve"> </Contact_Firstname>
>    <Contact_Lastname>Shaji Kumar</Contact_Lastname>
>    <Contact_Email />
>    <Contact_Tel />
>    <Contact_Affiliation>Mayo Clinic</Contact_Affiliation>
>    <Condition>Refractory Chronic Lymphocytic Leukemia;Refractory Multiple Myeloma;Stage III Multiple Myeloma;Stage IV Chronic Lymphocytic Leukemia;Unspecified Adult Solid Tumor, Protocol Specific</Condition>
>    <Intervention>Drug: 17-N-allylamino-17-demethoxygeldanamycin/bortezomib;Drug: sorafenib tosylate</Intervention>
>    <Primary_outcome>MTD as assessed by the number of patients with dose-limiting toxicity (DLT) using Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0);Toxicity as assessed by CTCAE v3.0;Antitumor activity as assessed by tumor measurement or evaluation of indicator lesion by computed tomography (CT) or magnetic resonance imaging (MRI);Effects of sorafenib on the disposition of bortezomib</Primary_outcome>
>    <Secondary_outcome>Tumor response as assessed by CT or MRI using modified Response Evaluation Criteria in Solid Tumors (RECIST);Best overall response as assessed using modified RECIST;Duration of overall response;Duration of stable disease</Secondary_outcome>
>    <Secondary_ID>MC0511;U01CA069912;NCI-2009-00124</Secondary_ID>
>    <Source_Support>Please refer to primary and secondary sponsors</Source_Support>
>  </Trial>
>  <Trial>
>    <TrialID>NCT00474929</TrialID>
>    <Last_Refreshed_on>19 February 2015</Last_Refreshed_on>
>    <Public_title>Sorafenib and Everolimus in Treating Patients With Relapsed or Refractory Lymphoma or Multiple Myeloma</Public_title>
>    <Scientific_title>A Phase I/II Study of the Raf Kinase/VEGFR Inhibitor Sorafenib in Combination With the mTOR Inhibitor RAD001 (Everolimus) in Patients With Relapsed Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Multiple Myeloma</Scientific_title>
>    <Acronym />
>    <Primary_sponsor>Mayo Clinic</Primary_sponsor>
>    <Date_registration>16/05/2007</Date_registration>
>    <Export_date>9/21/2016 10:21:51 PM</Export_date>
>    <Source_Register>ClinicalTrials.gov</Source_Register>
>    <web_address>http://clinicaltrials.gov/show/NCT00474929</web_address>
>    <Recruitment_Status>Not recruiting</Recruitment_Status>
>    <other_records>No</other_records>
>    <Inclusion_agemin>18 Years</Inclusion_agemin>
>    <Inclusion_agemax>N/A</Inclusion_agemax>
>    <Inclusion_gender>Both</Inclusion_gender>
>    <Date_enrollement>August 2007</Date_enrollement>
>    <Target_size>103</Target_size>
>    <Study_type>Interventional</Study_type>
>    <Study_design>Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment</Study_design>
>    <Phase>Phase 1/Phase 2</Phase>
>    <Countries>United States</Countries>
>    <Contact_Firstname> ; </Contact_Firstname>
>    <Contact_Lastname>Thomas E. Witzig, MD;Shaji K. Kumar, MD</Contact_Lastname>
>    <Contact_Email>;</Contact_Email>
>    <Contact_Tel>;</Contact_Tel>
>    <Contact_Affiliation>Mayo Clinic;Mayo Clinic</Contact_Affiliation>
>    <Condition>Lymphoma;Multiple Myeloma and Plasma Cell Neoplasm</Condition>
>    <Intervention>Drug: RAD001;Drug: Sorafenib</Intervention>
>    <Primary_outcome>Toxicity profile as assessed by NCI CTCAE v 3.0 (Phase I);Adverse events profile (Phase I);Proportion of confirmed tumor response (Phase II)</Primary_outcome>
>    <Secondary_outcome>Survival time (Phase II);Time to disease progression (Phase II)</Secondary_outcome>
>    <Secondary_ID>07-000710;LS0689;LS0689</Secondary_ID>
>    <Source_Support>Please refer to primary and secondary sponsors</Source_Support>
>    <Secondary_Sponsor>University of Iowa</Secondary_Sponsor>
>  </Trial>
>  <Trial>
>    <TrialID>NCT00536575</TrialID>
>    <Last_Refreshed_on>19 February 2015</Last_Refreshed_on>
>    <Public_title>Sorafenib and Bortezomib Treatment for Relapsed or Refractory Multiple Myeloma Patients</Public_title>
>    <Scientific_title>Phase I/II Trial of Sorafenib and Weekly Bortezomib in the Treatment of Patients With Relapsed or Refractory Multiple Myeloma</Scientific_title>
>    <Acronym />
>    <Primary_sponsor>SCRI Development Innovations, LLC</Primary_sponsor>
>    <Date_registration>26/09/2007</Date_registration>
>    <Export_date>9/21/2016 10:21:51 PM</Export_date>
>    <Source_Register>ClinicalTrials.gov</Source_Register>
>    <web_address>http://clinicaltrials.gov/show/NCT00536575</web_address>
>    <Recruitment_Status>Not recruiting</Recruitment_Status>
>    <other_records>No</other_records>
>    <Inclusion_agemin>18 Years</Inclusion_agemin>
>    <Inclusion_agemax>N/A</Inclusion_agemax>
>    <Inclusion_gender>Both</Inclusion_gender>
>    <Date_enrollement>November 2007</Date_enrollement>
>    <Target_size>13</Target_size>
>    <Study_type>Interventional</Study_type>
>    <Study_design>Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment</Study_design>
>    <Phase>Phase 1/Phase 2</Phase>
>    <Countries>United States</Countries>
>    <Contact_Firstname xml:space="preserve"> </Contact_Firstname>
>    <Contact_Lastname>Ian W. Flinn, M.D.</Contact_Lastname>
>    <Contact_Email />
>    <Contact_Tel />
>    <Contact_Affiliation>SCRI Development Innovations, LLC</Contact_Affiliation>
>    <Condition>Multiple Myeloma</Condition>
>    <Intervention>Drug: Bortezomib;Drug: Sorafenib</Intervention>
>    <Primary_outcome>Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment</Primary_outcome>
>    <Secondary_ID>SCRI MM 14</Secondary_ID>
>    <Source_Support>Please refer to primary and secondary sponsors</Source_Support>
>    <Secondary_Sponsor>Bayer</Secondary_Sponsor>
>  </Trial>
>  <Trial>
>    <TrialID>NCT00687674</TrialID>
>    <Last_Refreshed_on>19 February 2015</Last_Refreshed_on>
>    <Public_title>Sorafenib, Lenalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma</Public_title>
>    <Scientific_title>Phase I/II Study of Sorafenib, Lenalidomide, and Dexamethasone in Relapsed/Refractory Multiple Myeloma</Scientific_title>
>    <Acronym />
>    <Primary_sponsor>Mayo Clinic</Primary_sponsor>
>    <Date_registration>30/05/2008</Date_registration>
>    <Export_date>9/21/2016 10:21:51 PM</Export_date>
>    <Source_Register>ClinicalTrials.gov</Source_Register>
>    <web_address>http://clinicaltrials.gov/show/NCT00687674</web_address>
>    <Recruitment_Status>Not recruiting</Recruitment_Status>
>    <other_records>No</other_records>
>    <Inclusion_agemin>18 Years</Inclusion_agemin>
>    <Inclusion_agemax>N/A</Inclusion_agemax>
>    <Inclusion_gender>Both</Inclusion_gender>
>    <Date_enrollement>August 2008</Date_enrollement>
>    <Target_size>13</Target_size>
>    <Study_type>Interventional</Study_type>
>    <Study_design>Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment</Study_design>
>    <Phase>Phase 1/Phase 2</Phase>
>    <Countries>United States</Countries>
>    <Contact_Firstname xml:space="preserve"> </Contact_Firstname>
>    <Contact_Lastname>Shaji K. Kumar, M.D.</Contact_Lastname>
>    <Contact_Email />
>    <Contact_Tel />
>    <Contact_Affiliation>Mayo Clinic</Contact_Affiliation>
>    <Condition>Multiple Myeloma and Plasma Cell Neoplasm</Condition>
>    <Intervention>Drug: dexamethasone;Drug: sorafenib tosylate;Drug: Lenalidomide</Intervention>
>    <Primary_outcome>Number of Participants With a Grade 3 and 4 Adverse Event (Phase I);Number of Participants Who Achieve a Confirmed Response (Partial Response [PR], Very Good PR [VGPR], Complete Response [CR], or Stringent CR [sCR]) (Phase II)</Primary_outcome>
>    <Secondary_outcome>Overall Survival (Phase II);Time to Disease Progression (Phase II);Changes in Microvessel Density From Baseline to Post-treatment and Correlation With &gt; Clinical Outcomes (Phase II);Change in Apoptosis Rate From Baseline to Post-treatment and Correlation With &gt; Clinical Outcomes (Phase II);Plasma Cell Gene Expression Profiles and Correlation With &gt; Clinical Outcomes;Percentage of Stained Circulating Endothelial Cells and Endothelial Progenitor Cells and Correlation With Clinical Outcomes (Phase II;Change in VEGF Expression Levels and Correlation With Clinical Outcomes (Phase II)</Secondary_outcome>
>    <Secondary_ID>P30CA015083;MC078A;07-006234;NCI-2009-01284;RV-MM-PI-0142;SR06-933;CDR0000597065</Secondary_ID>
>    <Source_Support>Please refer to primary and secondary sponsors</Source_Support>
>    <Secondary_Sponsor>National Cancer Institute (NCI)</Secondary_Sponsor>
>  </Trial>
></Trials_downloaded_from_ICTRP>

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Attachments on bug 102337: 127530