NCT01204164

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Tragara Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• AML
• ALL
• Blast Crisis
• MDS
• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	TG02 citrate	TG02 citrate capsules given orally.
DRUG	Carfilzomib	Carfilzomib per PI
DRUG	Dexamethasone	Dexamethasone (Oral or IV)

Timeline

• Start date: 2010-08-01
• Primary completion: 2016-03-01
• Completion: 2016-04-01
• First posted: 2010-09-17
• Last updated: 2016-05-06

Locations

9 sites across 1 country: United States