Glufosfamide

TH-CR-302

TH-CR-302 is a randomized Phase 3 study designed to 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. Overall 303 patients were enrolled in the trial. While the overall survival in patients in the glufosfamide arm was 18% higher compared to those who received best supportive care alone, the result was not statistically significant. This trial is completed.

TH-CR-301

TH-CR-301 is a Phase 1/2 study that evaluted the efficacy and safety of glufosfamide in combination with gemcitabine in advanced solid tumors or in first line treatment of pancreatic cancer. In the Phase 2 portion of the clinical trial of glufosfamide in combination with gemcitabine for the treatment of advanced pancreatic cancer, six-month and one-year survival were 50% (95% CI: 31-67%) and 32% (95% CI: 16 - 49%), respectively. Median progression-free and overall survival were 3.7 and 6.0 months.

This trial is completed. Forty-six patients were enrolled at various sites in the US and Latin America. Patients participated in the study for up to 18 months.

Who Participated?

Selected Inclusion Criteria:

In order to participate in this study, a person must have met the following criteria:

• Must be at least 18 years of age
• Locally advanced or metastatic malingnancy (phase 1/2)
• Locally advanced or metastatic pancreatic cancer (phase 2)
• Measurable or non-measurable disease
• Recovered from reversible toxicities of prior therapy
• Karnofsky performance status ³70

Selected Exclusion Criteria:

• Prior chemotherapy for locally advanced metastatic pancreatic cancer (phase 2)
• Hormonal therapy, biologic therapy, chemotherapy or other systemic antitumor therapy for pancreatic cancer within 21 days prior to study start
• Radiation therapy 28 days prior to study start
• Symptomatic brain metastases (baseline CT scan is not required in asymptomatic subjects)
• Active clinically significant infection requiring antibiotics
• Known HIV positive or active hepatitis B or C
• History or symptoms of cardiovascular disease (NYHA Class 2, 3, or 4), particularly coronary artery disease, arrhythmias or conduction defects with risk of cardiovascular instability, uncontrolled hypertension, clinically significant pericardial effusion, or congestive heart failure
• No other active malignancies (other than treated non-melanoma skin cancer or treated in situ cancer) within the past year
• Major surgery within 3 weeks of the start of study treatment, without complete recovery

Disclosure of Risks

Please note that the safety and effectiveness of this product have not yet been established. As with other anti-cancer treatments, this investigational product may not benefit you and may cause side effects. These side effects could be severe or even life threatening. There may be side effects that are not known or predictable at this time, but that may occur at the time of treatment or later. You should discuss these risks with your physician or a study doctor.