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

Metastatic Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01028495
• Other study ID #: RX-0201-P2-A-07
• Status: Completed
• Phase: Phase 2
• Start date: May 2009
• Est. completion date: August 2012

Study information

• Verified date: September 2019
• Source: Rexahn Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: August 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Metastatic Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
India	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
United States	Texas Oncology	Austin	Texas
United States	Baptist Cancer Institute	Jacksonville	Florida
United States	Texas Oncology, P.A.	McAllen	Texas
United States	Orchard Healthcare Research Inc.	Skokie	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rexahn Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  India, 

References & Publications (2)

Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings Part I. Vol 25, No. 18S (June 20 Supplement), 2007: 3564

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival		7 Months
Secondary	Tumor Response		8 weeks assessment and 16 weeks to confirm
Secondary	Toxicity and Safety Parameters		Continuously
Secondary	Karnofsky Performance Scale, Clinical Laboratory Assessment, and Molecular Markers		Every 14 Days and Study Completion