A Safety and Efficacy Study of RX-0201 Plus Gemcitabine in Metastatic Pancreatic Cancer

Study Overview
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Brief Summary
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To assess the safety and efficacy of a combined therapy regimen of RX-0201 plus Gemcitabine, in subjects with metastatic pancreatic cancer.

Detailed Description
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Subjects enrolled to assess safety will receive a combination of Gemcitabine plus RX-0201. Gemcitabine will be administered prior to RX-0201 intravenously in a 30-min iv infusion dose at 1000 mg/m2 once weekly for up to 2 cycles; each 4-week cycle consist of 3-week treatment phase followed by 1 week resting phase. RX-0201 will be administered at 250 mg/m2/day in a 24-hour continuous intravenous infusion for up to 2 cycles; each 3-week cycle consists of 2-week treatment phase followed by a 1 week resting phase. (See schedule of assessments)Subjects enrolled to evaluate efficacy will receive a combination of Gemcitabine and RX-0201 as outline above for up to 4 cycles.

Official Title
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A Dose Tolerability and Efficacy Study of RX-0201 Plus Gemcitabine in Metastatic Pancreatic Cancer

Conditions
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Metastatic Pancreatic Cancer

Intervention / Treatment
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* Drug: RX-0201 plus Gemcitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide written informed consent prior to the initiation of study procedures. Are > 18 years of age Have metastatic pancreatic cancer. Have at least 1 measurable lesion by RECIST criteria. Have a Karnofsky Performance Status of > 70. Have at least a 6-month life expectancy as assessed by the investigator. Pre-menopausal women must be surgically sterile or agree to use an accepted method of birth control while participating in the study and for 30 days following the last exposure of study drug. Acceptable forms of birth control are: hormonal contraceptives (oral, injectable, transdermal or implant), double-barrier contraceptives (condom or diaphragm with spermicide), and intrauterine device (IUD). Male subjects need to either be surgically sterile or agree to use a barrier method of birth control described above during the study and for 30 days following the last exposure to study drug. The subject's agreed upon method of birth control will be discussed and documented in the subjects source document during the screening phase of the study. Exclusion Criteria: Are unwilling or unable to provide informed consent. Are unwilling or unable to comply with the requirements of the protocol. Have been treated with another investigational agent for pancreatic cancer. Have any of the following screening laboratory values: Hemoglobin < 8.0 grams/deciliter (g/dL) Absolute neutrophil count (ANC) < 1500/microliter (μL) Platelet count < 100,000/μL Serum creatinine > 1.5 x the institutional upper limit of normal (IULN) creatinine. Serum bilirubin > 1.5 X IULN Aspartate transaminase (AST) (serum glutamic oxaloacetic transaminase, SGOT) > 2 x IULN (> 5 x IULN in presence of known liver metastasis) Alanine transaminase (ALT) (serum glutamate pyruvate transaminase, SGPT) > 2 x IULN (> 5 x IULN in presence of known liver metastasis) Have a prothrombin time >1.25 x IULN on screening laboratory assessments. HCV or HBsAg positive subjects Have received therapeutic dose of either warfarin or heparin within 21 days before Day 1 (the first day of dosing; prophylactic use of warfarin or heparin) to maintain patency of indwelling IV catheters/lines is allowed Have a history of brain cancer (primary or metastatic). Have a history of an active hematologic malignancy within the past 2 years. Have an underlying diagnosis or disease state associated with an increased risk of bleeding (i.e., coagulopathies, HIV). Have a serious infection requiring intravenous antibiotic therapy during screening. Females who are pregnant, lactating, or have a positive serum pregnancy test during the screening period.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: gemcitabine and RX-0201<br>Gemcitabine at 1000 mg/day once a week for a 4 week cycle; 3 weeks of treatment at 30 minutes infusion once a week and one week off. RX-0201 3 week cycle at 250mg/m2/day of continuous infusion for 14 days with 7 days off. | Drug: RX-0201 plus Gemcitabine<br>* RX-0201 3 week cycle at 250mg/m2/day of continuous infusion for 14 days with 7 days off. Gemcitabine at 1000 mg/day once a week for a 4 week cycle; 3 weeks of treatment at 30 minutes infusion once a week and one week off.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | 7 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor Response |  | 8 weeks assessment and 16 weeks to confirm | 
| Toxicity and Safety Parameters |  | Continuously | 
| Karnofsky Performance Scale, Clinical Laboratory Assessment, and Molecular Markers |  | Every 14 Days and Study Completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AKT-1