A Safety And Efficacy Study Of RX-0201 Plus Gemcitabine In Metastatic Pancreatic Cancer

Study Overview

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

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

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.

Metastatic Pancreatic Cancer

DRUG: RX-0201 plus Gemcitabine

RX-0201-P2-A-07

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2009-12-07	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2019-09-10
First Submitted that Met QC Criteria 2009-12-08	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2019-09-12
First Posted (ACTUAL) 2009-12-09	Results First Posted N/A	Last Verified 2019-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: gemcitabine and RX-0201 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 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.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: gemcitabine and RX-0201

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

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.

Primary Outcome Measures	Measure Description	Time Frame
Survival		7 Months

Secondary Outcome Measures	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: Margaret Tempero, M.D,

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Yoon H, Kim DJ, Ahn EH, Gellert GC, Shay JW, Ahn CH, Lee YB. Antitumor activity of a novel antisense oligonucleotide against Akt1. J Cell Biochem. 2009 Nov 1;108(4):832-8. doi: 10.1002/jcb.22311.
Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings Part I. Vol 25, No. 18S (June 20 Supplement), 2007: 3564

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