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

Sponsor
Rexahn Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02030067
Collaborator
(none)
124
Enrollment
12
Locations
1
Arm
72
Duration (Months)
10.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
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

Study Type:
Interventional
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 :
Dec 1, 2013
Actual Primary Completion Date :
Jul 1, 2019
Actual Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: RX-3117

All subjects will receive RX-3117.

Drug: RX-3117
escalating doses (Phase 1)

Outcome Measures

Primary Outcome Measures

  1. Incidence of dose limiting toxicities (Phase 1) [4 weeks]

  2. Progression free survival and/or objective clinical response rate (Phase 2) [4 months]

Secondary Outcome Measures

  1. Area under the plasma concentration time curve (AUC) (Phase 1) [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) [Baseline and at 4, 8, 12, 16 and 32 weeks]

Other Outcome Measures

  1. Biomarker concentrations in blood (Phase 1 and Phase 2) [Baseline and 4, 8, 12, 16 and 32 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rexahn Site Birmingham Alabama United States 35294
2 Rexahn Site Tucson Arizona United States 85724
3 Rexahn Site Duarte California United States 91010
4 Rexahn Site Miami Lakes Florida United States 33014
5 Rexahn Site Miami Florida United States 33136
6 Rexahn Site Skokie Illinois United States 60077
7 Rexahn Site Saint Louis Missouri United States 63110
8 Rexahn Site Las Vegas Nevada United States 89119
9 Rexahn Site New York New York United States 10021
10 Rexahn Site San Antonio Texas United States 78229
11 Rexahn Site Salt Lake City Utah United States 84112
12 Rexahn Site Fairfax Virginia United States 22031

Sponsors and Collaborators

  • Rexahn Pharmaceuticals, Inc.

Investigators

  • Study Director: Ely Benaim, MD, Rexahn Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rexahn Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT02030067
Other Study ID Numbers:
  • RX-3117-P1-01
First Posted:
Jan 8, 2014
Last Update Posted:
Jan 6, 2020
Last Verified:
Jan 1, 2020
Keywords provided by Rexahn Pharmaceuticals, Inc.
oncology
tumor
metastatic
bladder
Additional relevant MeSH terms:
Urinary Bladder Neoplasms

Study Results

No Results Posted as of Jan 6, 2020