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
  Purpose

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


Condition Intervention Phase
Metastatic Pancreatic Cancer
Drug: RX-0201 plus Gemcitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Dose Tolerability and Efficacy Study of RX-0201 Plus Gemcitabine in Metastatic Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Rexahn Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Survival [ Time Frame: 7 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 31
Study Start Date: May 2009
Study Completion Date: August 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01028495

Locations
United States, Florida
Baptist Cancer Institute
Jacksonville, Florida, United States, 32207
United States, Illinois
Orchard Healthcare Research Inc.
Skokie, Illinois, United States, 60077
United States, Texas
Texas Oncology
Austin, Texas, United States, 78705
Texas Oncology, P.A.
McAllen, Texas, United States, 78705
India
Jawaharlal Nehru Cancer Hospital and Research Centre
Bhopal, Kerala, India, 462 001
Meenakshi Mission Hospital and Research Center
Madurai-625020, India
Central India Cancer Research Institute
Maharashtra, India
Shatabdi Superspeciality Hospital
Maharashtra, India
Rajiv Gandhi Cancer Institute and Research Center
Rohini New- Delhi, India
King George Hospital
Visakhapatanam, A.P, India
Sponsors and Collaborators
Rexahn Pharmaceuticals, Inc.
Investigators
Study Chair: Margaret Tempero, M.D
  More Information

Additional Information:
Publications:
Responsible Party: Rexahn Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01028495     History of Changes
Other Study ID Numbers: RX-0201-P2-A-07
Study First Received: December 7, 2009
Last Updated: August 28, 2012
Health Authority: United States: Food and Drug Administration
India: Ministry of Health

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 21, 2014