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

Completed · Phase 2

Conditions studied: Metastatic Pancreatic Cancer

In brief

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

Key facts

Study ID: NCT01028495
Run by: Rexahn Pharmaceuticals, Inc.
People needed: 31
Starts: 2009-05-01
Expected to finish: 2012-08-01
Last updated by the study team: 2019-09-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Baptist Cancer Institute — Jacksonville, Florida, United States
Orchard Healthcare Research Inc. — Skokie, Illinois, United States
Texas Oncology — Austin, Texas, United States
Texas Oncology, P.A. — McAllen, Texas, United States
Jawaharlal Nehru Cancer Hospital and Research Centre — Bhopal, Kerala, India
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

Full record on ClinicalTrials.gov

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