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Dose-Finding, Safety and Efficacy Study of RX-0201 Plus Everolimus in Metastatic Renal Cell Cancer

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ClinicalTrials.gov Identifier: NCT02089334
Recruitment Status : Recruiting
First Posted : March 17, 2014
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Rexahn Pharmaceuticals, Inc.

Brief Summary:
The purpose of this study is to determine the maximum tolerated dose of RX-0201, up to a target dose of 250 mg/m^2/day, when given in combination with everolimus (Stage 1), and to assess the safety and efficacy of RX-0201 plus everolimus, in subjects with metastatic renal cell cancer (Stage 2).

Condition or disease Intervention/treatment Phase
Metastatic Renal Cell Cancer Drug: RX-0201 Phase 1 Phase 2

Detailed Description:
This multi-center, open-label, randomized, parallel group study of RX-0201 in combination with everolimus, versus everolimus alone to treat subjects with advanced renal cell carcinoma will be conducted in 2 stages. Stage 1 will be an open-label, dose-escalation study of RX-0201 to identify a safe and tolerable dose of RX-0201 up to a target dose of 250 mg/m^2/day when given in combination with everolimus. Stage 2 will be a randomized, open-label, 2-arm study of RX-0201 in combination with everolimus versus everolimus alone. Subjects will receive RX-0201, at the dose identified in Stage 1, in combination with everolimus or everolimus alone, for up to 8 cycles to determine safety and efficacy of the combination.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label, Phase 1b/2 Study to Evaluate the Safety and Efficacy of RX-0201 in Combination With Everolimus to Treat Subjects With Advanced Renal Cell Carcinoma
Study Start Date : August 2014
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RX-0201 plus everolimus (Stage 1 & 2)
RX-0201 and everolimus will be taken together as described in the Interventions description.
Drug: RX-0201

RX-0201 will be administered in a dose up to 250mg/m^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1.

In Stage 2, RX-0201 will be administered the dose determined in Stage 1 as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles.

Other Name: Archexin




Primary Outcome Measures :
  1. Incidence of dose-limiting toxicities (DLTs) (Stage 1) [ Time Frame: after 1 cycle (3 weeks) of treatment with RX-0201 and everolimus ]
    Incidence of adverse events and clinical laboratory abnormalities defined as dose-limiting toxicities

  2. Progression Free Survival (Stage 2) [ Time Frame: 4 months of treatment with RX-0201 and everolimus ]

Secondary Outcome Measures :
  1. Area under the plasma concentration versus time curve (AUC) of RX-0201 (Stage 1) [ Time Frame: predose, 1, 2, 3, 4, 6, and 24 hours after start of Cycle 1 RX-0201 infusion, and then immediately prior to the end of Cycle 1 infusion (Day 15), 1, 2, 3, 4, 6, and 24 hours after infusion is stopped ]
  2. Incidence of adverse events, changes in clinical laboratory tests and vital signs over time (Stage 1 and Stage 2) [ Time Frame: up to 24 weeks of treatment with RX-0201 plus everolimus and at least 30 days of safety follow up ]
  3. Changes in tumor size [ Time Frame: Baseline and at weeks 6, 12, 18, and 24 ]

Other Outcome Measures:
  1. Biomarker concentrations in blood [ Time Frame: Baseline and at weeks 6, 12, 18, and 24 ]
  2. RX-0201 concentration in the blood (Stage 2 only) [ Time Frame: After 2 weeks of treatment ]


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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 and females ≥ 18 years of age at screening
  • Histological or cytological diagnosis of renal cell cancer with a clear-cell component
  • Measurable or evaluable disease defined by Response Evaluation Criteria for Solid Tumors (RECIST) ver. 1.1
  • Must have received at least one course of therapy with a VEGFR-targeting tyrosine kinase inhibitor (eg, sorafenib, sunitinib, axitinib, pazopanib or tivozanib) and progressed within 6 months of planned first dose of study treatment
  • ECOG performance status of 0,1 or 2
  • Life expectancy > 3 months
  • Provide written informed consent

Exclusion Criteria:

  • Brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery and stable for at least 3 months before planned first dose of study drug
  • Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before planned first dose of study drug. Systemic treatment with radionuclides within 6 weeks before planned first dose of study drug. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible
  • Prior treatment with everolimus, or any other specific or selective TORC1/PI3K/AKT inhibitor (eg, temsirolimus)
  • Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before planned first dose of study drug
  • Receipt of any type of anticancer antibody (including investigational antibody) within 4 weeks before planned first dose of study drug
  • Taking strong inducers or inhibitors of CYP450s for subjects receiving everolimus
  • Chronic treatment with corticosteroids or other immunosuppressive agents
  • Concomitant anticoagulation at therapeutic doses with oral anticoagulants or platelet inhibitors
  • Subjects with a known hypersensitivity to everolimus or other rapamycins (sirolimus, temsirolimus) or to its excipients
  • Major surgery within 2 months before planned first dose of study drug
  • Myocardial infarction within the previous 6 months before planned first dose of study drug
  • Active infection requiring parenteral antibiotics within 2 weeks before planned first dose of study drug
  • Diagnosis of another malignancy within 2 years before planned first dose of study drug, except for superficial skin cancers, or localized, low grade tumors
  • Prior or current history of hepatitis B, hepatitis C or human immunodeficiency virus
  • Sexually active fertile subjects (male and female) must agree to use medically accepted methods of contraception during the course of the study and for 30 days after the last dose of study treatment

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): NCT02089334


Contacts
Contact: Callie Heaton 240-268-5300 ext 312 heatonc@rexahn.com

Locations
United States, Arizona
Rexahn Site Active, not recruiting
Tucson, Arizona, United States, 85719
United States, California
Rexahn Site Terminated
Duarte, California, United States, 91010
United States, Florida
Rexahn Site Withdrawn
Miami, Florida, United States, 33136
United States, Illinois
Rexahn Site Withdrawn
Chicago, Illinois, United States, 60612
United States, Michigan
Rexahn Site Withdrawn
Grand Rapids, Michigan, United States, 49503
United States, New Mexico
Rexahn Site Recruiting
Albuquerque, New Mexico, United States, 87106
United States, New York
Rexahn Site Recruiting
Bronx, New York, United States, 10467
Rexahn Site Recruiting
New York, New York, United States, 10065
United States, Pennsylvania
Rexahn Site Withdrawn
Easton, Pennsylvania, United States, 18045
United States, Texas
Rexahn Site Withdrawn
Dallas, Texas, United States, 75230
United States, Utah
Rexahn Site Recruiting
Salt Lake City, Utah, United States, 84112
United States, Washington
Rexahn Site Recruiting
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Rexahn Pharmaceuticals, Inc.
Investigators
Study Director: Ely Benaim, MD Rexahn Pharmaceuticals, Inc.

Responsible Party: Rexahn Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02089334     History of Changes
Other Study ID Numbers: RX-0201-P2-A-09
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018

Keywords provided by Rexahn Pharmaceuticals, Inc.:
renal cell carcinoma
clear cell
renal cancer
metastatic renal cancer
Carcinoma, Renal Cell*/therapy
Humans
Kidney Neoplasms*/therapy

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents