Description:
RX108 is a novel, potent, small-molecule inhibitor of Na+/K+-ATPase. The purpose of this
study is to evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of RX108 in
patients with locally advanced or metastatic solid tumors.
Title
- Brief Title: A Study of RX108 in Patients With Locally Advanced or Metastatic Solid Tumors
- Official Title: A Phase 1, Open-label Study of the Safety, Pharmacokinetics and Efficacy of RX108 in Patients With Locally Advanced or Metastatic Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
NP-102
- NCT ID:
NCT03646071
Conditions
- Locally Advanced Solid Tumors
- Metastatic Solid Tumors
Interventions
| Drug | Synonyms | Arms |
|---|
| RX108 | | Dose Escalation Phase |
Purpose
RX108 is a novel, potent, small-molecule inhibitor of Na+/K+-ATPase. The purpose of this
study is to evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of RX108 in
patients with locally advanced or metastatic solid tumors.
Detailed Description
This is a open-label, two-part study comprised of a dose escalation part and a dose expansion
part. In the dose escalation part, RX108 will be administered in ascending doses to evaluate
the safety and tolerability of RX108 and determine the maximum tolerated dose (MTD) and/or
recommended Phase 2 dose (RP2D). The dose expansion part will assess the safety,
pharmacokinetics, and efficacy of RX108 at the RP2D.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Dose Escalation Phase | Experimental | The Dose-Escalation Phase will employ a standard 3+3 algorithm to investigate ascending dose cohorts of RX108. | |
| Dose Expansion Phase | Experimental | In the Expansion Phase, subjects will receive RX108 at the maximum tolerated dose. | |
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed locally advanced or metastatic cancer that has failed all
systemic therapies known to confer clinical benefit
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Minimum age of 18 years
- Adequate hematologic, hepatic and renal function
- Written Informed Consent
- Must agree to use adequate contraception (females and males)
Exclusion Criteria:
- History of certain cardiac abnormalities
- History of inadequate pulmonary function
- Symptomatic brain metastasis
- Treatment with prohibited medications
- Known contra-indication to digoxin
- Treatment with any unapproved therapies for cancer, or any other anti-cancer therapy
within 3 weeks
- Any toxicity related to prior treatment must have resolved to Grade 1 or less, with
the exception of alopecia
- Clinically significant active infection requiring systemic antibiotic treatment
- Females who are pregnant or breastfeeding
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Part 1: Maximum tolerated dose (MTD) of RX108 |
| Time Frame: | Day 1 to 30 |
| Safety Issue: | |
| Description: | All patients treated with RX108 across all dosing levels will have safety assessed in order to determine the MTD. |
Secondary Outcome Measures
| Measure: | Maximum observed plasma concentration (Cmax) of RX108 |
| Time Frame: | Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8 |
| Safety Issue: | |
| Description: | Pharmacokinetics parameter |
| Measure: | Time to reach maximum concentration (Tmax) |
| Time Frame: | Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8 |
| Safety Issue: | |
| Description: | Pharmacokinetics parameter |
| Measure: | Area under the plasma concentration-time curve (AUC) |
| Time Frame: | Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8 |
| Safety Issue: | |
| Description: | Pharmacokinetics parameter |
| Measure: | Elimination half-life (T1/2) |
| Time Frame: | Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8 |
| Safety Issue: | |
| Description: | Pharmacokinetics parameter |
| Measure: | Systemic clearance (CL) |
| Time Frame: | Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8 |
| Safety Issue: | |
| Description: | Pharmacokinetics parameter |
| Measure: | Response rate (per RECIST v1.1) |
| Time Frame: | Screening and every 2 cycles for the first 6 cycles and every 3 cycles thereafter (each cycle is 28 days), assessed up to 24 months. |
| Safety Issue: | |
| Description: | Evaluate the preliminary efficacy of RX108 in subjects with locally advanced or metastatic solid tumors (subjects with measurable disease in Part 2). |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | NeuPharma, Inc. |
Trial Keywords
- Locally Advanced
- Metastatic
- Solid Tumor
Last Updated
October 6, 2020
