Phase 2
Completed N=124
Dose-Finding and Safety Study for Oral Single-Agent to Treat Advanced Malignancies
Source: ClinicalTrials.gov NCT02030067 ↗Enrolled (actual)
124
Serious AEs
33.1%
Results posted
Dec 2023
Primary outcomePrimary: Overall Safety Profile Characterized by # of Subjects With Dose-limiting Toxicities (DLTs) in Phase 1 — 0; 0; 0; 0 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Safety Profile Characterized by # of Subjects With Dose-limiting Toxicities (DLTs) in Phase 1 |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Overall Safety Profile Characterized by Number of Subjects Experiencing Serious Adverse Events in Phase 1 |
0; 1; 0; 0; 0; 0 | — |
| PRIMARY Overall Safety Profile Characterized by the Number of Subjects That Discontinue Study Treatment - Phase 1 |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Overall Safety Profile Characterized by Number of Subjects Experiencing a Treatment Emergent Adverse Event- Phase 1 |
0; 1; 2; 3; 3; 0 | — |
| PRIMARY Progression Free Survival (Phase 2) |
4.7; 7.7 | — |
| SECONDARY Area Under the Plasma Concentration Time Curve (AUC) (Phase 1) |
— | — |
| SECONDARY Best Overall Response Rate (Phase 2) |
26.8; 45.2 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02030067). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.