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

Rexahn Pharmaceuticals

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Metastatic Renal Cell Cancer

Treatments

Drug: RX-0201

Study type

Interventional

Funder types

Industry

Identifiers

NCT02089334

RX-0201-P2-A-09

Details and patient eligibility

About

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).

Full 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.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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