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

NCT01028495 | Completed Phase 2 DMC

• 1 other identifier: RX-0201-P2-A-07
• Study Type: interventional
• Target: 31
• Locations: 2 countries
• Sites: 10

Brief Summary

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

Conditions

Metastatic Pancreatic Cancer

Keywords

AKT-1

Outcome Measures

Primary Outcomes (1)

• Survival

  7 Months

Secondary Outcomes (3)

• Tumor Response

  8 weeks assessment and 16 weeks to confirm

• Toxicity and Safety Parameters

  Continuously

• Karnofsky Performance Scale, Clinical Laboratory Assessment, and Molecular Markers

  Every 14 Days and Study Completion

Study Arms (1)

gemcitabine and RX-0201

EXPERIMENTAL

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

Interventions

RX-0201 plus Gemcitabine DRUG

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.

gemcitabine and RX-0201

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Rexahn Pharmaceuticals, Inc.: lead

Study Sites (10)

Baptist Cancer Institute

Jacksonville, Florida, 32207, United States

Location

Orchard Healthcare Research Inc.

Skokie, Illinois, 60077, United States

Location

Texas Oncology

Austin, Texas, 78705, United States

Location

Texas Oncology, P.A.

McAllen, Texas, 78705, United States

Location

Jawaharlal Nehru Cancer Hospital and Research Centre

Bhopal, Kerala, 462 001, India

Location

Meenakshi Mission Hospital and Research Center

Madurai-625020, India

Location

Central India Cancer Research Institute

Maharashtra, India

Location

Shatabdi Superspeciality Hospital

Maharashtra, India

Location

Rajiv Gandhi Cancer Institute and Research Center

Rohini New- Delhi, India

Location

King George Hospital

Visakhapatanam, A.P, India

Location

Related Publications (2)

• 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.

  PMID: 19693774 BACKGROUND

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

  RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

RX-0201; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Margaret Tempero, M.D

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2009
• First Posted: December 9, 2009
• Study Start: May 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: August 1, 2012
• Last Updated: September 12, 2019

Record last verified: 2019-09

Locations

US (4); IN (6)