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

Processa Pharmaceuticals

Status and phase

Completed

Phase 2

Phase 1

Conditions

Solid Tumor

Metastatic Bladder Cancer

Treatments

Drug: RX-3117

Study type

Interventional

Funder types

Industry

Identifiers

NCT02030067

RX-3117-P1-01

Details and patient eligibility

About

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).

Full 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.

Enrollment

127 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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