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BRIEF TITLE: A Phase 1, Open-Label, Dose-Ranging, Safety and Pharmacokinetic Study to Determine the Maximum Tolerated Dose of RX-3117 Administered Orally as a Single-Agent to Subjects With Advanced Malignancies

A Phase 1, Open-Label, Dose-Ranging, Safety and Pharmacokinetic Study to Determine the Maximum Tolerated Dose of RX-3117 Administered Orally as a Single-Agent to Subjects With Advanced Malignancies


  • Org Study ID: RX-3117-P1-01
  • Secondary ID:
  • NCT ID: NCT02030067
  • NCT Alias:
  • Sponsor: Rexahn Pharmaceuticals, Inc. - Industry
  • Source: Rexahn Pharmaceuticals, Inc.

Brief Summary

The purpose of this study is to determine the maximum tolerated dose of RX-3117 in subjects with advanced or metastatic solid tumors (Phase 1). The purpose of the Phase 2 portion is to estimate anti-tumor activity in subjects with advanced malignancies (relapsed or refractory pancreatic or advanced bladder cancer).

Detailed Description


This is a dose-finding, open-label, single agent study of RX-3117. Once the maximum tolerated
dose is identified additional subjects will be treated in a dose expansion followed by a
2-stage Phase 2 study. Subjects will be treated for up to 8 cycles of therapy. A cycle will
be 4 weeks. RX-3117 dosing will be 3 times each week for 3 weeks follow by 1 week off
treatment. All subjects will be followed for at least 30 days after the last dose of RX-3117.

Overal Status Start Date Phase Study Type
Recruiting Start Date: December 2013 Phase 1/Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Incidence of dose limiting toxicities (Phase 1)

Primary Outcome 1 - Time Frame: 4 weeks

Primary Outcome 2 - Measure: Progression free survival and/or objective clinical response rate (Phase 2)

Primary Outcome 2 - Time Frame: 4 months

Condition:

  • Solid Tumor
  • Metastatic Bladder Cancer

Eligibility

Criteria:
Inclusion Criteria:

- Males or females who are 18 years or older

- Able to swallow capsules

- Histological or cytological evidence of confirmed metastatic pancreatic or advanced
bladder cancer

- Able to discontinue all anticancer therapies 2 weeks prior to study start

- Measurable or evaluable disease using Response Evaluation Criteria in Solid Tumors

- Life expectancy of at least 3 months

- ECOG performance status of 0 or 1

- Provide written informed consent

Exclusion Criteria:

- Primary brain tumors or clinical evidence of active brain metastasis

- Systemic corticosteroid use within 7 days before planned start of study therapy

- Active infection requiring parenteral or oral antibiotics within 2 weeks before
planned start of study therapy

- Uncontrolled diabetes as assessed by the investigator

- Prior or current history of hepatitis B, hepatitis C or human immunodeficiency virus

- History of bone marrow of solid organ transplantation

- History of congestive heart failure, arrhythmias, acute coronary syndrome or torsades
de pointes

- Any other medical, psychiatric, or social condition, which in the opinion of the
investigator, would preclude participation in the study, pose an undue medical hazard,
interfere with the conduct of the study, or interfere with interpretation of the study
results

- Known hypersensitivity to gemcitabine, azacytidine or cytosine arabinoside

- Pregnant, planning a pregnancy or breast feeding during the study

- Concurrent participation in another therapeutic clinical trial
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Ely Benaim, MD

Role: Study Director

Affiliation: Rexahn Pharmaceuticals, Inc.

Overall Contact

Name: Christine Peterson, PhD

Phone: 240-268-5300

Email: petersonc@rexahn.com

Locations

Facility Status Contact
Rexahn Site
Birmingham, Alabama 35294
United States
Completed
Rexahn Site
Tucson, Arizona 85724
United States
Recruiting
Rexahn Site
Duarte, California 91010
United States
Recruiting
Rexahn Site
Miami Lakes, Florida 33014
United States
Completed
Rexahn Site
Miami, Florida 33136
United States
Active, not recruiting
Rexahn Site
Skokie, Illinois 60077
United States
Completed
Rexahn Site
Saint Louis, Missouri 63110
United States
Recruiting
Rexahn Site
Las Vegas, Nevada 89119
United States
Completed
Rexahn Site
New York, New York 10021
United States
Recruiting
Rexahn Site
San Antonio, Texas 78229
United States
Completed
Rexahn Site
Salt Lake City, Utah 84112
United States
Recruiting
Rexahn Site
Fairfax, Virginia 22031
United States
Completed