Clinical trial NCT03646071: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Locally Advanced Solid Tumors
Metastatic Solid Tumors
Keywords: Locally Advanced
Metastatic
Solid Tumor
Lead sponsor: NeuPharma, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Part 1: Maximum tolerated dose (MTD) of RX108
timeFrame: Day 1 to 30
measure: Part 2: Incidence of adverse events (AEs) and serious adverse events (SAEs).
timeFrame: Day 1 to 30 days post last dose
Secondary outcomes:
measure: Maximum observed plasma concentration (Cmax) of RX108
timeFrame: Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8
measure: Time to reach maximum concentration (Tmax)
timeFrame: Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8
measure: Area under the plasma concentration-time curve (AUC)
timeFrame: Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8
measure: Elimination half-life (T1/2)
timeFrame: Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8
measure: Systemic clearance (CL)
timeFrame: Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8
measure: Response rate (per RECIST v1.1)
timeFrame: 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.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai
state: California
city: Houston
country: United States
facility: University of Texas at MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Medpace, Inc.
name: Lyon Gleich, MD
role: STUDY_DIRECTOR
References: