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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01028495
Recruitment Status : Completed
First Posted : December 9, 2009
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Rexahn Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE December 7, 2009
First Posted Date  ICMJE December 9, 2009
Last Update Posted Date September 12, 2019
Study Start Date  ICMJE May 2009
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2010)
Survival [ Time Frame: 7 Months ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 8, 2009)
Median Survival and Time to Progression [ Time Frame: 7 Months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2010)
  • Tumor Response [ Time Frame: 8 weeks assessment and 16 weeks to confirm ]
  • Toxicity and Safety Parameters [ Time Frame: Continuously ]
  • Karnofsky Performance Scale, Clinical Laboratory Assessment, and Molecular Markers [ Time Frame: Every 14 Days and Study Completion ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2009)
  • Tumor Response [ Time Frame: 8 weeks ]
  • Toxicity and Safety Parameters--Adverse event reporting, physical examinations, vital signs, ECGs, the Karnofsky performance status, and laboratory assessments to include serum chemistry, hematology, coagulation, Creatine Kinase, and urinalysis. [ Time Frame: Every 14 Days and Study Completion ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety and Efficacy Study of RX-0201 Plus Gemcitabine in Metastatic Pancreatic Cancer
Official Title  ICMJE A Dose Tolerability and Efficacy Study of RX-0201 Plus Gemcitabine in Metastatic Pancreatic Cancer
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Pancreatic Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE 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.

Intervention: Drug: RX-0201 plus Gemcitabine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 28, 2012)
31
Original Estimated Enrollment  ICMJE
 (submitted: December 8, 2009)
26
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01028495
Other Study ID Numbers  ICMJE RX-0201-P2-A-07
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rexahn Pharmaceuticals, Inc.
Study Sponsor  ICMJE Rexahn Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Margaret Tempero, M.D
PRS Account Rexahn Pharmaceuticals, Inc.
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP