Locally Advanced Solid TumorsPhase 1NCT03646071
A Study of RX108 in Patients With Locally Advanced or Metastatic Solid Tumors
A Phase 1 study testing RX108 in people with Locally Advanced Solid Tumors and Metastatic Solid Tumors, run by NeuPharma, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Solid Tumors, Metastatic Solid Tumors
- What is being tested?
- RX108
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2018to Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
University of Texas at MD Anderson Cancer Center
Houston, Texas, 77030
Lidong Liu, PhD, lliu8@mdanderson.org
Siqing Fu, MD
- Recruiting
Cedars-Sinai
Los Angeles, California, 90048
Vanessa Cajahuaringa, 310-967-2795, vanessa.cajahuaringa@cshs.org
Monica Mita, MD
About this study
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
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.
Read the 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.
- Being tested
- RX108
- Keywords
- Locally Advanced, Metastatic, Solid Tumor
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RX108Drug
RX108
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Phase | Experimental | The Dose-Escalation Phase will employ a standard 3+3 algorithm to investigate ascending dose cohorts of RX108. Receives: Drug: RX108 |
| Dose Expansion Phase | Experimental | In the Expansion Phase, subjects will receive RX108 at the maximum tolerated dose. Receives: Drug: RX108 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Maximum tolerated dose (MTD) of RX108
All patients treated with RX108 across all dosing levels will have safety assessed in order to determine the MTD.
Measured: Day 1 to 30
Part 2: Incidence of adverse events (AEs) and serious adverse events (SAEs).
The incidence of adverse events (AEs) and serious adverse events (SAEs) for each cohort dose will be assessed using CTCAE v 5.0.
Measured: Day 1 to 30 days post last dose
Secondary outcomes (6)
Maximum observed plasma concentration (Cmax) of RX108
Pharmacokinetics parameter
Measured: Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8
Time to reach maximum concentration (Tmax)
Pharmacokinetics parameter
Measured: Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8
Area under the plasma concentration-time curve (AUC)
Pharmacokinetics parameter
Measured: Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8
Elimination half-life (T1/2)
Pharmacokinetics parameter
Measured: Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8
Systemic clearance (CL)
Pharmacokinetics parameter
Measured: Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8
Response rate (per RECIST v1.1)
Evaluate the preliminary efficacy of RX108 in subjects with locally advanced or metastatic solid tumors (subjects with measurable disease in Part 2).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start1 Aug 2018
- Primary completionAug 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeuPharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lyon Gleich, MD, Study director, Medpace, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03646071
- Sponsor's protocol ID
- NP-102
- Status last verified
- Apr 2022
- First submitted
- 18 Jul 2018
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To be determined.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03646071
- Acronym / sponsor ID
- NP-102
- Keywords
- Locally Advanced, Metastatic, Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- NeuPharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 24 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Phase | Experimental | Drug: RX108The Dose-Escalation Phase will employ a standard 3+3 algorithm to investigate ascending dose cohorts of RX108. |
| Dose Expansion Phase | Experimental | Drug: RX108In the Expansion Phase, subjects will receive RX108 at the maximum tolerated dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- History of certain cardiac abnormalities
- History of inadequate pulmonary function
- Symptomatic brain metastasis
- Treatment with prohibited medications
- Known contra-indication to digoxin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RX108RX108 | Drug | Dose Escalation Phase, Dose Expansion Phase |
Primary outcome
Part 1: Maximum tolerated dose (MTD) of RX108
Time frame: Day 1 to 30
All patients treated with RX108 across all dosing levels will have safety assessed in order to determine the MTD.
Part 2: Incidence of adverse events (AEs) and serious adverse events (SAEs).
Time frame: Day 1 to 30 days post last dose
The incidence of adverse events (AEs) and serious adverse events (SAEs) for each cohort dose will be assessed using CTCAE v 5.0.
6 secondary outcomes
Maximum observed plasma concentration (Cmax) of RX108
Time frame: Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8
Time to reach maximum concentration (Tmax)
Time frame: Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8
Area under the plasma concentration-time curve (AUC)
Time frame: Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8
Elimination half-life (T1/2)
Time frame: Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8
Systemic clearance (CL)
Time frame: Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Individual participant dataSharing planned: Undecided. To be determined.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lyon Gleich, MD study director
Medpace, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RX108 in people with Locally Advanced Solid Tumors and Metastatic Solid Tumors, run by NeuPharma, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lyon Gleich, MD ((513) 579-9911 ext. 12400, l.gleich@medpace.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Maximum tolerated dose (MTD) of RX108 (time frame: Day 1 to 30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2022.