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

Primary Purpose

Metastatic Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
RX-0201 plus Gemcitabine
Sponsored by
Rexahn Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Pancreatic Cancer focused on measuring AKT-1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Baptist Cancer Institute
  • Orchard Healthcare Research Inc.
  • Texas Oncology
  • Texas Oncology, P.A.
  • Jawaharlal Nehru Cancer Hospital and Research Centre
  • Meenakshi Mission Hospital and Research Center
  • Central India Cancer Research Institute
  • Shatabdi Superspeciality Hospital
  • Rajiv Gandhi Cancer Institute and Research Center
  • King George Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

gemcitabine and RX-0201

Arm Description

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.

Outcomes

Primary Outcome Measures

Survival

Secondary Outcome Measures

Tumor Response
Toxicity and Safety Parameters
Karnofsky Performance Scale, Clinical Laboratory Assessment, and Molecular Markers

Full Information

First Posted
December 7, 2009
Last Updated
September 10, 2019
Sponsor
Rexahn Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01028495
Brief Title
A Safety and Efficacy Study of RX-0201 Plus Gemcitabine in Metastatic Pancreatic Cancer
Official Title
A Dose Tolerability and Efficacy Study of RX-0201 Plus Gemcitabine in Metastatic Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rexahn Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Pancreatic Cancer
Keywords
AKT-1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
gemcitabine and RX-0201
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
RX-0201 plus Gemcitabine
Intervention Description
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 Measure Information:
Title
Survival
Time Frame
7 Months
Secondary Outcome Measure Information:
Title
Tumor Response
Time Frame
8 weeks assessment and 16 weeks to confirm
Title
Toxicity and Safety Parameters
Time Frame
Continuously
Title
Karnofsky Performance Scale, Clinical Laboratory Assessment, and Molecular Markers
Time Frame
Every 14 Days and Study Completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret Tempero, M.D
Official's Role
Study Chair
Facility Information:
Facility Name
Baptist Cancer Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Orchard Healthcare Research Inc.
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Texas Oncology
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Texas Oncology, P.A.
City
McAllen
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Jawaharlal Nehru Cancer Hospital and Research Centre
City
Bhopal
State/Province
Kerala
ZIP/Postal Code
462 001
Country
India
Facility Name
Meenakshi Mission Hospital and Research Center
City
Madurai-625020
Country
India
Facility Name
Central India Cancer Research Institute
City
Maharashtra
Country
India
Facility Name
Shatabdi Superspeciality Hospital
City
Maharashtra
Country
India
Facility Name
Rajiv Gandhi Cancer Institute and Research Center
City
Rohini New- Delhi
Country
India
Facility Name
King George Hospital
City
Visakhapatanam, A.P
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
19693774
Citation
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.
Results Reference
background
Citation
Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings Part I. Vol 25, No. 18S (June 20 Supplement), 2007: 3564
Results Reference
result

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

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