Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hematologic Neoplasms

Blast Crisis

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Leukemia

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Leukemia, Myeloid

Cell Transformation, Neoplastic

Carcinogenesis

Neoplastic Processes

Myeloproliferative Disorders

Bone Marrow Diseases

Chronic Disease

Disease Attributes

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Chronic Myeloproliferative Disorders

Anti-Inflammatory Agents

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All Drugs and Chemicals

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Dexamethasone

Dexamethasone acetate

BB 1101

Citric Acid

Sodium Citrate

Glucocorticoids

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Antineoplastic Agents, Hormonal

Citrate

Single agent TG02 citrate in acute leukemia patients

Single Agent TG02 citrate in multiple myeloma patients

TG02 in combination with carfilzomib and dexamethasone in multiple myeloma patients

TG02 in combination with carfilzomib and dexamethasone in carfilzomib refractory multiple myeloma patients

TG02 citrate

Carfilzomib

T Parrott

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

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.

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

Maximum Tolerated Dose refers to the highest dose of TG02 administered that will produce the desired effect without unacceptable toxicity.

Safety data will include vital signs, ECGs, PE findings, clinical laboratory parameters, ECOG PS, AEs/SAEs and concomitant medications.

Plasma will be analyzed to determine TG02 concentration.

Clinical Benefit Response is defined as the sum of all response categories for Overall Response Rate (ORR is defined as the sum of patients with sCR, CR, VGPR and PR) plus minimal response (MR).

Overall Response Rate is defined as the sum of patients with sCR, CR, VGPR and PR.

Progression-Free Survival is the time to disease progression or death, which is measured from the date of first study drug administration until the first date that recurrent or progressive disease is objectively documented or the date of death.

Overall Survival is time to death, which is measured from the date of first study drug administration until the date of death.

Duration of Response is the duration from first observation of response to the first documentation of disease progression, with deaths from causes other than disease progression censored. For the purposes of the calculation of the DOR, the date at which the response status was first observed rather than the date of confirmation is used as the start date.

Pharmacodynamic sampling may include whole blood and bone marrow at baseline and post-treatment for pathway determination if available.

Tragara Pharmaceuticals, Inc.

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

TG02 Citrate

This is a single-centre, open-label, dose escalation, Phase 1 study. The primary objective is to determine the highest dose of TG02 citrate that can safely be given to patients with advanced hepatocellular carcinoma.

Study of TG02 Citrate in Patients With Advanced Hepatocellular Carcinoma

A Phase 1 Dose-Escalation and Pharmacokinetic Study of TG02 Citrate in Patients With Advanced Hepatocellular Carcinoma

Correlation of molecular marker, c-MYC, with measures of clinical benefit.

To assess the number of patients with dose-limiting toxicities (DLT) and the dose of TG02 citrate that can be safely given to patients with advanced hepatocellular carcinoma.

All adverse events will be graded according to NCI-CTCAE, Version 4

Proportion of patients, whose best overall response is either Complete Response or Partial Response, confirmed at least 4 weeks after initial documentation.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase 1 Study of TG02 Citrate in Patients With Advanced Hematological Malignancies	NCT01204164	AML ALL Blast Crisis MDS Multiple Myelom...	TG02 citrate Carfilzomib Dexamethasone	18 Years -	Tragara Pharmaceuticals, Inc.
Study of TG02 Citrate in Patients With Advanced Hepatocellular Carcinoma	NCT03738111	Hepatocellular ...	TG02 Citrate	18 Years -	Lee's Pharmaceutical Limited

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