Spots Global Cancer Trial Database for Phase 1 Study of TG02 Citrate in Patients With Advanced Hematological Malignancies

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Trial Identification

Brief Title: Phase 1 Study of TG02 Citrate in Patients With Advanced Hematological Malignancies

Official Title: Phase 1 Dose-Escalation and Pharmacokinetic Study of TG02 Citrate in Patients With Advanced Hematological Malignancies

Study ID: NCT01204164

Conditions

Interventions

TG02 citrate

Carfilzomib

Dexamethasone

Study Description

Brief Summary: This is a multicenter, open-label, dose escalation Phase 1 study.

Detailed Description: This is a multicenter, open-label, dose escalation, Phase 1/1b study. For Parts 1, 2, and 3 of the study, the primary objective is to determine the highest dose of TG02 citrate that can safely be given to patients with different types of hematological malignancy. For Part 4, the primary objective is to evaluate the safety and tolerability of once-weekly dosing at the maximum-tolerated dose/ Recommended Phase 2 Dose of TG02 in combination with carfilzomib. This study consists of four parts: * Part 1: single agent TG02 in acute leukemia patients * Part 2: single agent TG02 in multiple myeloma patients * Part 3: TG02 in combination with carfilzomib in multiple myeloma patients * Part 4: TG02 in combination with carfilzomib in carfilzomib refractory multiple myeloma patients.