Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle

1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle

1-hour infusion of glufosfamide at a dose of 2,500 mg/m2 on Days 1, 8 and 15 of a 21-day cycle

Glufosfamide

David Alberts, MD

Michael Gordon, MD

Daniela Matei, MD

Peter D Eisenberg, MD

Larry Puls, MD

Krishnansu Tewari, MD

Nashat Gabrail, MD

Jeffrey Goldberg, MD

Claire Verschraegen, M.D.

William Robinson, MD

Primary Objectives:

* To evaluate the effect of glufosfamide on the serum concentrations of CA125 in subjects with ovarian cancer
* To evaluate the safety of weekly glufosfamide dosing in subjects with ovarian cancer as compared with every 21-day dosing

Secondary objectives:

* To evaluate the efficacy of glufosfamide in subjects with ovarian cancer as measured by objective response rate, duration of response, progression-free survival, and overall survival
* To evaluate the pharmacokinetics of glufosfamide and isophosphoramide mustard during and after treatment

Exploratory objective:

* To correlate efficacy endpoints with expression of tumor-associated glucose transporter proteins

Open-label, multicenter, Phase 2 dose escalation study. Subjects will be randomized to receive either once every three weeks dosing regimen or the weekly dosing regimen. Randomization will utilize a 2:1 ratio with two-thirds of the subjects randomized to the weekly dosing regimen.

In the weekly dosing schedule, treatment with glufosfamide 2,500 mg/m2 will be initiated only after the 1,660 mg/m2 treatment cohort has been enrolled and there is evidence that the dose of 1,660 mg/m2 has been well tolerated (See below Section on Pharmacokinetic/Statistical Analyses).

Safety and Efficacy Study of Glufosfamide in Ovarian Cancer

An Open-Label Phase 2 Study of the Safety and Efficacy of Glufosfamide in Ovarian Cancer

Reduction in blood levels of CA 125 of \>50% from baseline, confirmed at the next study cycle.

Objective response rate measured by RECIST v1.0

Time from initiation of study drug to disease progression or death on study

Time from initiation of study drug to death.

Eleison Pharmaceuticals LLC.

1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle

Glufosfamide

Glufosfamide q21 Days

1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle

Glufosfamide

Glufosfamide q7 Days Low

1-hour infusion of glufosfamide at a dose of 2,500 mg/m2 on Days 1, 8 and 15 of a 21-day cycle

Glufosfamide

Glufosfamide q7 Days High

Total

<=18 years

Between 18 and 65 years

>=65 years

Age, Categorical

Age, Continuous

Female

Male

Gender

American Indian or Alaska Native

Asian

Native Hawaiian or Other Pacific Islander

Black or African American

White

More than one race

Unknown or Not Reported

Race (NIH/OMB)

VP Clinical Development

Partial response

Stable disease

CA 125 Response Rate

Progressive disease

Objective Response Rate

Progression-free Survival

Overall Survival

Overall Study

Digestive System Diseases

Adenocarcinoma

Pancreatic Neoplasms

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Fluorouracil

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Glufosfamide: 4500 mg/m2 IV over 6 hours on Day 1 of each 21-day cycle

Fluorouracil (5-FU): 600 mg/m2 IV over 30 minutes on Day 1 of each week

Glufosfamide: 4500 mg/m2 IV over 6 hours (¼ dose over 30 minutes, ¾ dose over remaining 5.5 hours) on Day 1 of each 21-day cycle.

Edwin Thomas

Kirsten Bettino

Richy Agajanian, MD

Michael Rowland

Richard Kim, MD

Carrie Smith

The study is designed to assess whether glufosfamide provides additional survival benefit as compared to bolus 5-FU in patients with metastatic pancreatic cancer who have already progressed or failed therapy on a gemcitabine based first line regimen.

Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer

A Randomized Phase 3 Study of the Efficacy and Safety of Glufosfamide Compared With Fluorouracil (5-FU) in Patients With Metastatic Pancreatic Adenocarcinoma Previously Treated With Gemcitabine

Time from Randomization to death from any cause

Sarcoma

Neoplasms, Connective and Soft Tissue

Soft Tissue Sarcoma

5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles.

Lee Cranmer, MD, PhD

David Mendelson, MD

Douglas Adkins, MD

Gina D'Amato, MD

Gerald Rosen, MD

Claire Verschraegen, MD

Kristen Ganjoo, MD

Primary Objective:

1. To evaluate the efficacy of glufosfamide in subjects with advanced soft tissue sarcoma as measured by objective response rate

Secondary Objectives:

1. To evaluate the efficacy of glufosfamide in subjects with advanced soft tissue sarcoma as measured by duration of response, progression-free survival and overall survival
2. To evaluate the safety of glufosfamide in subjects with advanced soft tissue sarcoma

Exploratory Objectives:

1. To evaluate the biological effect of glufosfamide on the metabolic profile in subjects with advanced soft tissue sarcomas, as determined by FDG-PET
2. To correlate efficacy endpoints with expression of tumor-associated glucose transporter proteins

Safety and Efficacy Study of Glufosfamide in Previously Treated Advanced Soft Tissue Sarcoma

An Open-Label Phase 2 Study of the Efficacy and Safety of Glufosfamide in Previously Treated Advanced Soft Tissue Sarcoma

The event rate was the response rate (complete and partial response) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.0). The associated 95% exact binomial confidence intervals were calculated.

Threshold Pharmaceuticals

Glufosfamide

Glufosfamide: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles.

Sex: Female, Male

Patients receiving glufosfamide with a post treatment imaging assessment

Symptoms and General Pathology

Nervous System Diseases

Recurrence

Glioblastoma

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Gliosarcoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Brain Tumor, Adult

Neuroepithelioma

glufosfamide

Martin J. van Den Bent, MD

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of glufosfamide in treating patients who have recurrent glioblastoma multiforme.

OBJECTIVES: I. Determine the activity of glufosfamide, in terms of objective response rate and/or progression-free survival at 6 months, in patients with recurrent glioblastoma multiforme. II. Determine the duration of objective response in patients treated with this regimen. III. Determine the toxic effects and pharmacokinetic profile of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients receive glufosfamide IV over 60 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients with stable disease receive treatment for a minimum of 6 months or until progression. Patients with an objective complete response receive a maximum of 2 additional courses of treatment after confirmation of response. Patients are followed every 6 weeks until progression.

PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study.

Glufosfamide in Treating Patients With Recurrent Glioblastoma Multiforme

Open Label Phase II Study On Glufosfamide Administered As A 60 Minute Infusion Every 3 Weeks In Recurrent Glioblastoma Multiforme

European Organisation for Research and Treatment of Cancer - EORTC

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Gastrointestinal Agents

Pancrelipase

Pancreatin

The primary objectives of the study is to evaluate the effectiveness and safety of glufosfamide in subjects with pancreatic cancer who have been previously treated with gemcitabine as measured by overall survival compared with best supportive care.

TH-CR-302 is a randomized Phase 3 study that will evaluate the efficacy and safety of glufosfamide plus best supportive care (BSC) compared to BSC alone for second line treatment of metastatic pancreatic cancer. BSC includes all medical or surgical interventions that a pancreatic cancer patient should receive to palliate the cancer but excludes treatment with systemic therapies intended to kill the cancer cells.

Study Hypothesis: Glufosfamide will provide benefits in survival to patients with metastatic pancreatic cancer over best supportive care.

Comparison: Glufosfamide versus best supportive care.

Study of the Efficacy and Safety of Glufosfamide Compared With Best Supportive Care in Metastatic Pancreatic Cancer

A Randomized Phase 3 Study of the Efficacy and Safety of Glufosfamide Compared With Best Supportive Care in Metastatic Pancreatic Adenocarcinoma Previously Treated With Gemcitabine

Respiratory Tract (Lung and Bronchial) Diseases

Immune System Diseases

Small Cell Lung Carcinoma

Carcinoma, Small Cell

Lung Neoplasms

Hypersensitivity

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Gerold Bepler, MD, PhD

John C Ruckdeschel, MD

The primary objectives of this study are:

1. To evaluate the efficacy of glufosfamide in subjects with extensive recurrent sensitive small cell lung cancer (SCLC) as measured by objective response rate
2. To evaluate the safety of glufosfamide in subjects with extensive recurrent sensitive SCLC

The secondary objectives are:

1. To evaluate the efficacy of glufosfamide in subjects with extensive recurrent sensitive SCLC as measured by duration of response, progression-free survival and overall survival
2. To evaluate the pharmacokinetics of glufosfamide and isophosphoramide mustard (IPM)

The exploratory objectives of this trial are:

1. To evaluate the effect of glufosfamide on lung cancer symptoms
2. To evaluate the role of tumor cell glucose transporter expression on the efficacy of glufosfamide

Safety and Efficacy Study of Glufosfamide in Patients With Recurrent Sensitive Small Cell Lung Carcinoma

An Open-Label, Phase 2 Study to Evaluate the Safety and Efficacy of Glufosfamide in the Treatment of Patients With Recurrent Sensitive Small Cell Lung Carcinoma

The purpose of this study is to determine the safety of glufosfamide when administered in combination with gemcitabine.

This study, TH-CR-301, is a Phase 1/2 study that will evaluate the efficacy and safety of glufosfamide in combination with gemcitabine in advanced solid tumors or in first line treatment of pancreatic cancer.

Study Hypothesis: Glufosfamide in combination with gemcitabine may provide benefits in survival to patients with advanced solid tumors or metastatic pancreatic cancer.

Study of Safety and Efficacy of Glufosfamide in Combination With Gemcitabine in Cancer

A Phase 1/2 Dose-Escalation Study of the Safety, Efficacy and Pharmacokinetics of Glufosfamide in Combination With Gemcitabine in Advanced Solid Tumors and Pancreatic Adenocarcinoma

Nicholas A. Pavlidis, MD

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Hydration with a saline solution may protect kidney cells from the side effects of chemotherapy.

PURPOSE: Randomized phase II trial to compare the effectiveness of glufosfamide with or without hydration in treating patients who have pancreatic cancer that is metastatic or cannot be removed by surgery.

OBJECTIVES: I. Determine the activity of glufosfamide as determined by objective response in patients with metastatic or inoperable locally advanced pancreatic cancer. II. Determine the response rate in this patient population after this treatment. III. Determine the duration of objective response in these patients on this treatment. IV. Determine the toxic effects of this regimen in these patients. V. Assess the impact of hydration on the toxicity profile of this treatment in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms: Arm I: Patients receive glufosfamide IV over 1 hour on day 1. Arm II: Patients receive glufosfamide as in arm I. Patients are hydrated with excess physiological saline solution 4 hours before and for 3 hours after treatment with glufosfamide. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients with an objective complete response continue treatment for a maximum of 2 courses beyond confirmation of response. Patients are followed every 6 weeks until disease progression.

PROJECTED ACCRUAL: A total of 16-32 patients (8-16 per arm) will be accrued for this study.

Glufosfamide With or Without Hydration in Treating Patients With Advanced Pancreatic Cancer

Open Label Phase II Study on Glufosfamide Administered as a 60 Minute Infusion Every 3 Weeks in Advanced Pancreatic Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Efficacy Study of Glufosfamide in Ovarian Cancer	NCT00442598	Ovarian Cancer	Glufosfamide	18 Years -	Eleison Pharmaceuticals LLC.
Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer	NCT01954992	Metastatic Panc...	Glufosfamide Fluorouracil	18 Years -	Eleison Pharmaceuticals LLC.
Safety and Efficacy Study of Glufosfamide in Previously Treated Advanced Soft Tissue Sarcoma	NCT00441467	Soft Tissue Sar...	Glufosfamide	18 Years -	Eleison Pharmaceuticals LLC.
Glufosfamide in Treating Patients With Recurrent Glioblastoma Multiforme	NCT00014300	Brain and Centr...	glufosfamide	18 Years -	European Organisation for Research and Treatment of Cancer - EORTC
Study of the Efficacy and Safety of Glufosfamide Compared With Best Supportive Care in Metastatic Pancreatic Cancer	NCT00099294	Pancreatic Canc...	Glufosfamide	18 Years -	Threshold Pharmaceuticals
Safety and Efficacy Study of Glufosfamide in Previously Treated Advanced Soft Tissue Sarcoma	NCT00441467	Soft Tissue Sar...	Glufosfamide	18 Years -	Eleison Pharmaceuticals LLC.
Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer	NCT01954992	Metastatic Panc...	Glufosfamide Fluorouracil	18 Years -	Eleison Pharmaceuticals LLC.
Safety and Efficacy Study of Glufosfamide in Previously Treated Advanced Soft Tissue Sarcoma	NCT00441467	Soft Tissue Sar...	Glufosfamide	18 Years -	Eleison Pharmaceuticals LLC.
Safety and Efficacy Study of Glufosfamide in Patients With Recurrent Sensitive Small Cell Lung Carcinoma	NCT00435578	Carcinoma, Smal...	Glufosfamide	18 Years -	Threshold Pharmaceuticals
Study of Safety and Efficacy of Glufosfamide in Combination With Gemcitabine in Cancer	NCT00102752	Neoplasms Pancreatic Neop...	Glufosfamide Gemcitabine	18 Years -	Threshold Pharmaceuticals
Glufosfamide With or Without Hydration in Treating Patients With Advanced Pancreatic Cancer	NCT00005053	Pancreatic Canc...	glufosfamide	18 Years -	European Organisation for Research and Treatment of Cancer - EORTC
Safety and Efficacy Study of Glufosfamide in Ovarian Cancer	NCT00442598	Ovarian Cancer	Glufosfamide	18 Years -	Eleison Pharmaceuticals LLC.

Spots Global Cancer Trial Database for glufosfamide

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