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

September 10, 2019 updated by: Rexahn Pharmaceuticals, Inc.

A Dose Tolerability 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • India
      • Madurai-625020, India
        • Meenakshi Mission Hospital and Research Center
      • Maharashtra, India
        • Central India Cancer Research Institute
      • Maharashtra, India
        • Shatabdi Superspeciality Hospital
      • Rohini New- Delhi, India
        • Rajiv Gandhi Cancer Institute and Research Center
      • Visakhapatanam, A.P, India
        • King George Hospital
    • Kerala
      • Bhopal, Kerala, India, 462 001
        • Jawaharlal Nehru Cancer Hospital and Research Centre
  • United States
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Baptist Cancer Institute
    • Illinois
      • Skokie, Illinois, United States, 60077
        • Orchard Healthcare Research Inc.
    • Texas
      • Austin, Texas, United States, 78705
        • Texas Oncology
      • McAllen, Texas, United States, 78705
        • Texas Oncology, P.A.

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

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

How is the study designed?

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival
Time Frame: 7 Months
7 Months

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Rexahn Pharmaceuticals, Inc.

Investigators

  • Study Chair: Margaret Tempero, M.D

Publications and helpful links

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

General Publications

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 Major Dates

Study Start

May 1, 2009

Primary Completion (ACTUAL)

July 1, 2012

Study Completion (ACTUAL)

August 1, 2012

Study Registration Dates

First Submitted

December 7, 2009

First Submitted That Met QC Criteria

December 8, 2009

First Posted (ESTIMATE)

December 9, 2009

Study Record Updates

Last Update Posted (ACTUAL)

September 12, 2019

Last Update Submitted That Met QC Criteria

September 10, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RX-0201-P2-A-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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