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Southwest Oncology Group Registration Form (S0502) NCT00324987

- 20-09-21 - 1 Formulier, 3 Itemgroepen, 38 Data-elementen, 1 Taal
Itemgroepen: Header, Patient demographics, Miscellaneous Patient Information
Southwest Oncology Group Registration Form (S0502) NCT00324987 S0502 Imatinib Mesylate With or Without Bevacizumab in Treating Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=398EB7EC-7565-1438-E044-0003BA3F9857

WTZ-GIST-09-01 (Imatinib + LBH589) Dosage administration record 2009-011417-24 DRKS00000657 - WTZ-GIST-09-01 (Imatinib + LBH589) Dosage administration record 2009-011417-24

- 15-12-16 - 1 Formulier, 2 Itemgroepen, 20 Data-elementen, 1 Taal
Itemgroepen: Dosage administration, Contribution of study medication
Phase I study of panobinostat and imatinib in patients with treatment-refractory metastatic gastrointestinal stromal tumors WTZ-GIST-09-01 (EudraCT number: 2009-011417-24; German Clinical Trials Register: DRKS00000657) was approved by the institutional ethics committees of the two participating centers and the German Federal Regulatory Drug Agency (BfArM; 4035954).

WTZ-GIST-09-01 (Imatinib + LBH589) Follow-Up 2009-011417-24 DRKS00000657 - WTZ-GIST-09-01 (Imatinib + LBH589) Follow-Up 2009-011417-24

- 02-12-16 - 1 Formulier, 1 Itemgroep, 14 Data-elementen, 1 Taal
Itemgroep: Follow Up
Phase I study of panobinostat and imatinib in patients with treatment-refractory metastatic gastrointestinal stromal tumors WTZ-GIST-09-01 (EudraCT number: 2009-011417-24; German Clinical Trials Register: DRKS00000657) was approved by the institutional ethics committees of the two participating centers and the German Federal Regulatory Drug Agency (BfArM; 4035954).

WTZ-GIST-09-01 (Imatinib + LBH589) End of study report 2009-011417-24 DRKS00000657 - WTZ-GIST-09-01 (Imatinib + LBH589) End of study report 2009-011417-24

- 02-12-16 - 1 Formulier, 3 Itemgroepen, 10 Data-elementen, 1 Taal
Itemgroepen: End of study report, Premature end of study, Date
Phase I study of panobinostat and imatinib in patients with treatment-refractory metastatic gastrointestinal stromal tumors WTZ-GIST-09-01 (EudraCT number: 2009-011417-24; German Clinical Trials Register: DRKS00000657) was approved by the institutional ethics committees of the two participating centers and the German Federal Regulatory Drug Agency (BfArM; 4035954).

WTZ-GIST-09-01 (Imatinib + LBH589) Final Medical Examination 2009-011417-24 DRKS00000657 - WTZ-GIST-09-01 (Imatinib + LBH589) Final Medical Examination 2009-011417-24

- 02-12-16 - 1 Formulier, 1 Itemgroep, 16 Data-elementen, 1 Taal
Itemgroep: Final medical examination
Phase I study of panobinostat and imatinib in patients with treatment-refractory metastatic gastrointestinal stromal tumors WTZ-GIST-09-01 (EudraCT number: 2009-011417-24; German Clinical Trials Register: DRKS00000657) was approved by the institutional ethics committees of the two participating centers and the German Federal Regulatory Drug Agency (BfArM; 4035954).

WTZ-GIST-09-01 (Imatinib + LBH589) Concomitant Therapies 2009-011417-24 DRKS00000657 - WTZ-GIST-09-01 (Imatinib + LBH589) Concomitant Therapies 2009-011417-24

- 02-12-16 - 1 Formulier, 1 Itemgroep, 8 Data-elementen, 1 Taal
Itemgroep: Concomitant Therapies
Phase I study of panobinostat and imatinib in patients with treatment-refractory metastatic gastrointestinal stromal tumors WTZ-GIST-09-01 (EudraCT number: 2009-011417-24; German Clinical Trials Register: DRKS00000657) was approved by the institutional ethics committees of the two participating centers and the German Federal Regulatory Drug Agency (BfArM; 4035954).

WTZ-GIST-09-01 (Imatinib + LBH589) Tumor Evaluation 2009-011417-24 DRKS00000657 - WTZ-GIST-09-01 (Imatinib + LBH589) Tumor Evaluation 2009-011417-24

- 02-12-16 - 1 Formulier, 1 Itemgroep, 5 Data-elementen, 1 Taal
Itemgroep: Low-Dose PET-CT
Phase I study of panobinostat and imatinib in patients with treatment-refractory metastatic gastrointestinal stromal tumors WTZ-GIST-09-01 (EudraCT number: 2009-011417-24; German Clinical Trials Register: DRKS00000657) was approved by the institutional ethics committees of the two participating centers and the German Federal Regulatory Drug Agency (BfArM; 4035954).

WTZ-GIST-09-01 (Imatinib + LBH589) Tumor evaluation RECIST Day 57 2009-011417-24 DRKS00000657 - WTZ-GIST-09-01 (Imatinib + LBH589) Tumor evaluation RECIST Day 57 2009-011417-24

- 02-12-16 - 1 Formulier, 4 Itemgroepen, 18 Data-elementen, 1 Taal
Itemgroepen: Target Lesion, Non-Target-Lesions, New Lesions, RECIST Criteria
Phase I study of panobinostat and imatinib in patients with treatment-refractory metastatic gastrointestinal stromal tumors WTZ-GIST-09-01 (EudraCT number: 2009-011417-24; German Clinical Trials Register: DRKS00000657) was approved by the institutional ethics committees of the two participating centers and the German Federal Regulatory Drug Agency (BfArM; 4035954).

WTZ-GIST-09-01 (Imatinib + LBH589) Tumor evaluation RECIST screening 2009-011417-24 DRKS00000657 - WTZ-GIST-09-01 (Imatinib + LBH589) Tumor evaluation RECIST screening 2009-011417-24

- 02-12-16 - 1 Formulier, 4 Itemgroepen, 18 Data-elementen, 1 Taal
Itemgroepen: Target Lesion, Non-Target-Lesions, New Lesions, RECIST Criteria
Phase I study of panobinostat and imatinib in patients with treatment-refractory metastatic gastrointestinal stromal tumors WTZ-GIST-09-01 (EudraCT number: 2009-011417-24; German Clinical Trials Register: DRKS00000657) was approved by the institutional ethics committees of the two participating centers and the German Federal Regulatory Drug Agency (BfArM; 4035954).

WTZ-GIST-09-01 (Imatinib + LBH589) Tumor evaluation RECIST 2009-011417-24 DRKS00000657 - WTZ-GIST-09-01 (Imatinib + LBH589) Tumor evaluation RECIST 2009-011417-24

- 02-12-16 - 1 Formulier, 4 Itemgroepen, 18 Data-elementen, 1 Taal
Itemgroepen: Target Lesion, Non-Target-Lesions, New Lesions, RECIST Criteria
Phase I study of panobinostat and imatinib in patients with treatment-refractory metastatic gastrointestinal stromal tumors WTZ-GIST-09-01 (EudraCT number: 2009-011417-24; German Clinical Trials Register: DRKS00000657) was approved by the institutional ethics committees of the two participating centers and the German Federal Regulatory Drug Agency (BfArM; 4035954).

WTZ-GIST-09-01 (Imatinib + LBH589) Additional Cycle lab results Haematology 2009-011417-24 DRKS00000657 - WTZ-GIST-09-01 (Imatinib + LBH589) Additional Cycle lab results Haematology 2009-011417-24

- 01-12-16 - 1 Formulier, 2 Itemgroepen, 15 Data-elementen, 1 Taal
Itemgroepen: Chemotherapy Regimen, Laboratory Tests
Phase I study of panobinostat and imatinib in patients with treatment-refractory metastatic gastrointestinal stromal tumors WTZ-GIST-09-01 (EudraCT number: 2009-011417-24; German Clinical Trials Register: DRKS00000657) was approved by the institutional ethics committees of the two participating centers and the German Federal Regulatory Drug Agency (BfArM; 4035954).

WTZ-GIST-09-01 (Imatinib + LBH589) Additional week laboratory results Blood/ Urinanalysis 2009-011417-24 DRKS00000657 - WTZ-GIST-09-01 (Imatinib + LBH589) Additional week laboratory results Blood/ Urinanalysis 2009-011417-24

- 01-12-16 - 1 Formulier, 3 Itemgroepen, 32 Data-elementen, 1 Taal
Itemgroepen: Chemotherapy Regimen, Laboratory results Blood chemistry, Urinanalysis
Phase I study of panobinostat and imatinib in patients with treatment-refractory metastatic gastrointestinal stromal tumors WTZ-GIST-09-01 (EudraCT number: 2009-011417-24; German Clinical Trials Register: DRKS00000657) was approved by the institutional ethics committees of the two participating centers and the German Federal Regulatory Drug Agency (BfArM; 4035954).

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