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Southwest Oncology Group Registration Form (S0502) NCT00324987

- 20.09.21 - 1 Formular, 3 Itemgruppen, 38 Datenelemente, 1 Sprache
Itemgruppen: 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 Formular, 2 Itemgruppen, 20 Datenelemente, 1 Sprache
Itemgruppen: 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 Formular, 1 Itemgruppe, 14 Datenelemente, 1 Sprache
Itemgruppe: 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) Final Medical Examination 2009-011417-24 DRKS00000657 - WTZ-GIST-09-01 (Imatinib + LBH589) Final Medical Examination 2009-011417-24

- 02.12.16 - 1 Formular, 1 Itemgruppe, 16 Datenelemente, 1 Sprache
Itemgruppe: 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) 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 Formular, 3 Itemgruppen, 10 Datenelemente, 1 Sprache
Itemgruppen: 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) Concomitant Therapies 2009-011417-24 DRKS00000657 - WTZ-GIST-09-01 (Imatinib + LBH589) Concomitant Therapies 2009-011417-24

- 02.12.16 - 1 Formular, 1 Itemgruppe, 8 Datenelemente, 1 Sprache
Itemgruppe: 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 Formular, 1 Itemgruppe, 5 Datenelemente, 1 Sprache
Itemgruppe: 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 Formular, 4 Itemgruppen, 18 Datenelemente, 1 Sprache
Itemgruppen: 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 Formular, 4 Itemgruppen, 18 Datenelemente, 1 Sprache
Itemgruppen: 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 Formular, 4 Itemgruppen, 18 Datenelemente, 1 Sprache
Itemgruppen: 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) Adverse Event 2009-011417-24 DRKS00000657 - WTZ-GIST-09-01 (Imatinib + LBH589) Adverse Event 2009-011417-24

- 01.12.16 - 1 Formular, 1 Itemgruppe, 14 Datenelemente, 1 Sprache
Itemgruppe: Adverse Event
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 2009-011417-24 DRKS00000657 - WTZ-GIST-09-01 (Imatinib + LBH589) Additional Cycle 2009-011417-24

- 01.12.16 - 1 Formular, 2 Itemgruppen, 16 Datenelemente, 1 Sprache
Itemgruppen: Chemotherapy Regimen, Vital signs
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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