Dose-Finding and Safety Study for Oral Single-Agent to Treat Advanced Malignancies
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02030067 |
Recruitment Status :
Completed
First Posted : January 8, 2014
Last Update Posted : January 6, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Solid Tumor Metastatic Bladder Cancer | Drug: RX-3117 | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 124 participants |
Allocation: | N/A |
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 |
Actual Primary Completion Date : | July 2019 |
Actual Study Completion Date : | December 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: RX-3117
All subjects will receive RX-3117.
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Drug: RX-3117
escalating doses (Phase 1) |
- Incidence of dose limiting toxicities (Phase 1) [ Time Frame: 4 weeks ]
- Progression free survival and/or objective clinical response rate (Phase 2) [ Time Frame: 4 months ]
- 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 ]
- Overall response rate, time to progression and duration of response (Phase 2) [ Time Frame: Baseline and at 4, 8, 12, 16 and 32 weeks ]
- Biomarker concentrations in blood (Phase 1 and Phase 2) [ Time Frame: Baseline and 4, 8, 12, 16 and 32 weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
Study Director: | Ely Benaim, MD | Rexahn Pharmaceuticals, Inc. |
Responsible Party: | Rexahn Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT02030067 |
Other Study ID Numbers: |
RX-3117-P1-01 |
First Posted: | January 8, 2014 Key Record Dates |
Last Update Posted: | January 6, 2020 |
Last Verified: | January 2020 |
oncology tumor metastatic bladder |
Urinary Bladder Neoplasms Neoplasms Urologic Neoplasms Urogenital Neoplasms |
Neoplasms by Site Urinary Bladder Diseases Urologic Diseases |