Clinical trial NCT01028495: A Safety and Efficacy Study of RX-0201 Plus Gemcitabine in Metastatic Pancreatic Cancer
Official title: A Dose Tolerability and Efficacy Study of RX-0201 Plus Gemcitabine in Metastatic Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Pancreatic Cancer
Keywords: AKT-1
Lead sponsor: Rexahn Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2009-12-09
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Survival
timeFrame: 7 Months
Secondary outcomes:
measure: Tumor Response
timeFrame: 8 weeks assessment and 16 weeks to confirm
measure: Toxicity and Safety Parameters
timeFrame: Continuously
measure: Karnofsky Performance Scale, Clinical Laboratory Assessment, and Molecular Markers
timeFrame: Every 14 Days and Study Completion
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Baptist Cancer Institute
state: Florida
city: Skokie
country: United States
facility: Orchard Healthcare Research Inc.
state: Illinois
city: Austin
country: United States
facility: Texas Oncology
state: Texas
city: McAllen
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Bhopal
country: India
facility: Jawaharlal Nehru Cancer Hospital and Research Centre
state: Kerala
city: Madurai-625020
country: India
facility: Meenakshi Mission Hospital and Research Center
city: Maharashtra
country: India
facility: Central India Cancer Research Institute
city: Maharashtra
country: India
facility: Shatabdi Superspeciality Hospital
city: Rohini New- Delhi
country: India
facility: Rajiv Gandhi Cancer Institute and Research Center
city: Visakhapatanam, A.P
country: India
facility: King George Hospital
Study officials:
name: Margaret Tempero, M.D
role: STUDY_CHAIR
References:
citation: 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.
citation: Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings Part I. Vol 25, No. 18S (June 20 Supplement), 2007: 3564