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Dose-Finding and Safety Study for Oral Single-Agent to Treat Advanced Malignancies

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ClinicalTrials.gov Identifier: NCT02030067
Recruitment Status : Active, not recruiting
First Posted : January 8, 2014
Last Update Posted : January 3, 2019
Sponsor:
Information provided by (Responsible Party):
Rexahn Pharmaceuticals, Inc.

Study Description
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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).

Condition or disease Intervention/treatment Phase
Solid Tumor Metastatic Bladder Cancer Drug: RX-3117 Phase 1 Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : December 2013
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: RX-3117
All subjects will receive RX-3117.
 Drug: RX-3117
escalating doses (Phase 1)


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of dose limiting toxicities (Phase 1) [ Time Frame: 4 weeks ]
  2. Progression free survival and/or objective clinical response rate (Phase 2) [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Area under the plasma concentration time curve (AUC) (Phase 1) [ Time Frame: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 24 and 48 hours after oral administration in Cycle 1 Days 1 and 15 ]
  2. Overall response rate, time to progression and duration of response (Phase 2) [ Time Frame: Baseline and at 4, 8, 12, 16 and 32 weeks ]

Other Outcome Measures:
  1. Biomarker concentrations in blood (Phase 1 and Phase 2) [ Time Frame: Baseline and 4, 8, 12, 16 and 32 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02030067


Locations
United States, Alabama
Rexahn Site
Birmingham, Alabama, United States, 35294
United States, Arizona
Rexahn Site
Tucson, Arizona, United States, 85724
United States, California
Rexahn Site
Duarte, California, United States, 91010
United States, Florida
Rexahn Site
Miami Lakes, Florida, United States, 33014
Rexahn Site
Miami, Florida, United States, 33136
United States, Illinois
Rexahn Site
Skokie, Illinois, United States, 60077
United States, Missouri
Rexahn Site
Saint Louis, Missouri, United States, 63110
United States, Nevada
Rexahn Site
Las Vegas, Nevada, United States, 89119
United States, New York
Rexahn Site
New York, New York, United States, 10021
United States, Texas
Rexahn Site
San Antonio, Texas, United States, 78229
United States, Utah
Rexahn Site
Salt Lake City, Utah, United States, 84112
United States, Virginia
Rexahn Site
Fairfax, Virginia, United States, 22031
Sponsors and Collaborators
Rexahn Pharmaceuticals, Inc.
Investigators
Study Director: Ely Benaim, MD Rexahn Pharmaceuticals, Inc.
More Information
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Responsible Party: Rexahn Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02030067     History of Changes
Other Study ID Numbers: RX-3117-P1-01
First Posted: January 8, 2014    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: January 2019

Keywords provided by Rexahn Pharmaceuticals, Inc.:
oncology
tumor
metastatic
bladder

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Urinary Bladder Diseases
Urologic Diseases