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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rexahn Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01028495
First received: December 7, 2009
Last updated: August 28, 2012
Last verified: August 2012

December 7, 2009
August 28, 2012
May 2009
July 2012   (final data collection date for primary outcome measure)
Survival [ Time Frame: 7 Months ] [ Designated as safety issue: No ]
Median Survival and Time to Progression [ Time Frame: 7 Months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01028495 on ClinicalTrials.gov Archive Site
  • Tumor Response [ Time Frame: 8 weeks assessment and 16 weeks to confirm ] [ Designated as safety issue: No ]
  • Toxicity and Safety Parameters [ Time Frame: Continuously ] [ Designated as safety issue: Yes ]
  • Karnofsky Performance Scale, Clinical Laboratory Assessment, and Molecular Markers [ Time Frame: Every 14 Days and Study Completion ] [ Designated as safety issue: Yes ]
  • Tumor Response [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Safety and Efficacy Study of RX-0201 Plus Gemcitabine in Metastatic Pancreatic Cancer
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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Pancreatic Cancer
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.
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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
August 2012
July 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   India
 
NCT01028495
RX-0201-P2-A-07
Yes
Rexahn Pharmaceuticals, Inc.
Rexahn Pharmaceuticals, Inc.
Not Provided
Study Chair: Margaret Tempero, M.D
Rexahn Pharmaceuticals, Inc.
August 2012

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