TGR-1202, a PI3K Delta Inhibitor, in Combination With Obi... | NCT02100852 | Trialant

TGR-1202, a PI3K Delta Inhibitor, in Combination With Obi... | NCT02100852 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TGR-1202 + Obinutuzumab + Chlorambucil	Experimental	TGR-1202 is an oral daily dose with obinutuzumab at a fixed IV infusion and chlorambucil as an oral dose on specified days.	Drug: TGR-1202 + Obinutuzumab + Chlorambucil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TGR-1202 + Obinutuzumab + Chlorambucil	Drug	TGR-1202: Oral dose Obinutuzumab: IV infusion Chlorambucil: Oral dose	TGR-1202 + Obinutuzumab + Chlorambucil

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum Tolerated Dose acceptable for participants	To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities	28 days (1 cycle of therapy)

Secondary Outcomes

Measure	Description	Time Frame
Overall Response Rate	To assess the overall response rate (ORR) in patients with chronic lymphocytic leukemia treated with TGR-1202 in combination with obinutuzumab (Gazyva) and chlorambucil	Up to 1 year

Contacts/Locations Module

Ancestor Terms

ID	Term
D015448	Leukemia, B-Cell
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms