Mass balance, Nonrandomized, COMPLETED 2012-09-24 SDTM v1.2 / CDISC SDTM Control None, SDTM IG 3.1.2 Terminology 11 Pharmacokinetics and Single Group, 2012-03-23 Metabolism of SDSP-002 Open Label, SDTM administered orally in Safety/Efficacy/ define.xml 1.0 MedDRA patients with Advanced Pharmacokinetic, (Adverse Events) Non-hematologic Basic Science ADaM v2.1 / 15.0 Malignancies ADaM IG 1.0 MedDRA ADaM (Medical History) define.xml 1.0 15.0 WHO-DD (Medications) 2012-03 1 Interventional Studies - Advanced Solid Tumors or Relapsed/Refractory Lymphoma SDSP-002 in patients with Randomized, ONGOING 2014-04-21 SDTM v1.3 / CDISC SDTM Control None, SDTM IG 3.1.3 Terminology Advanced Tumors or Parallel, 2013-10-04 Relapsed/Refractory Double Blind, SDTM Lymphoma with Varying Safety/Tolerability/ define.xml 1.0 MedDRA Degrees of Hepatic Pharmacokinetic/ (Adverse Events) Function Pharmacodynamic, ADaM v2.1 / 16.0 Treatment ADaM IG 1.0 WHO-DD ADaM (Medications) define.xml 1.0 2013-03
Mass balance, Pharmacokinetics and Metabolism of SDSP-002 administered orally in patients with Advanced Non-hematologic Malignancies Nonrandomized, Control None, Single Group, Open Label, Safety/Efficacy/ Pharmacokinetic, Basic Science COMPLETED 2012-09-24 SDTM v1.2 / SDTM IG 3.1.2 SDTM define.xml 1.0 ADaM v2.1 / ADaM IG 1.0 ADaM define.xml 1.0 CDISC SDTM Terminology 2012-03-23 MedDRA (Adverse Events) 15.0 MedDRA (Medical History) 15.0 WHO-DD (Medications) 2012-03 1 Interventional Studies - Advanced Solid Tumors or Relapsed/Refractory Lymphoma SDSP-002 in patients with Advanced Tumors or Relapsed/Refractory Lymphoma with Varying Degrees of Hepatic Function Randomized, Control None, Parallel, Double Blind, Safety/Tolerability/ Pharmacokinetic/ Pharmacodynamic, Treatment ONGOING 2014-04-21 SDTM v1.3 / SDTM IG 3.1.3 SDTM define.xml 1.0 ADaM v2.1 / ADaM IG 1.0 ADaM define.xml 1.0 CDISC SDTM Terminology 2013-10-04 MedDRA (Adverse Events) 16.0 WHO-DD (Medications) 2013-03 11