Carcinoma, Non-Small-Cell LungPhase 2NCT02875340
A Study of VAL401 in the Treatment of Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
A Phase 2 study testing VAL401 in people with Carcinoma, Non-Small-Cell Lung and Adenocarcinoma, run by ValiSeek Limited.
Trial summary
The objectives of this study are to assess the safety, tolerability, pharmacokinetics and efficacy of VAL401 in the treatment of patients with locally advanced or metastatic non-small cell lung adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Adenocarcinoma
- What is being tested?
- VAL401
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Sep 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Pathologically confirmed diagnosis of Stage IIIB or Stage IV adenocarcinoma of the lung. Patients with mixed histology will be eligible if adenocarcinoma is the predominant histology.
- Measurable disease according to RECIST version 1.1.
- Prior chemotherapy for relapsed or metastatic non small cell lung cancer.
- Life expectancy of at least 3 months.
- Negative human chorionic gonadotropin (hCG) test in women of childbearing potential (defined as women ≤ 50 years of age or history of amenorrhea for ≤ 12 months prior to study screening). Sexually active male and female patients of childbearing potential must agree to use an effective method of birth control e.g. barrier methods with spermicides, oral or parenteral contraceptives and/or intrauterine devices, during the entire duration of the study and for 1 month after the final administration of VAL401. Note that female patients may be surgically sterile (with appropriate documentation in the patient's medical records).
- Ability to give written, informed consent prior to any study-specific screening procedures with the understanding that the consent may be withdrawn by the patient at any time without prejudice.
- Patient is capable of understanding the protocol requirements, is willing and able to comply with the study protocol procedures, and has signed the informed consent document.
Who cannot join
- Radiotherapy or surgery (other than biopsy) within 4 weeks prior to Cycle 1 Day 1.
- Any chemotherapy regimens (including investigational agents) with delayed toxicity with 6 weeks of Cycle 1 Day 1, or received any chemotherapy regimens given continuously or on a weekly basis which have limited potential for delayed toxicity within 2 weeks prior to Cycle 1 Day 1. Palliative treatment regimens, and other concomitant drugs regimens are permitted with stable toxicity, and recording of all concomitant medications (including herbal).
- Pregnant or lactating female patients.
- Active hepatitis B or C or other active liver disease (other than malignancy).
- Any active, clinically significant, viral, bacterial, or systemic fungal infection within 2 weeks prior to Cycle 1 Day 1; other than cytomegalovirus which may be present providing any required concomitant anti-viral treatment is recorded appropriately.
- Known human immunodeficiency virus positivity.
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- History of clinically significant cardiac condition, including ischemic cardiac event, myocardial infarction or unstable cardiac disease with 3 months prior to Cycle 1 Day 1.
- Active brain metastases (defined as stable for <4 weeks and/or symptomatic and/or requiring treatment with anticonvulsants or steroids and/or leptomeningeal disease).
- Any known contraindications to Risperidone or patients who would not be eligible to receive the treatment as defined in the Special Warnings and Precautions section of the local label for Risperidone.
- Any medical history that in the Investigator's opinion would jeopardise compliance with the protocol.
About this study
Official title: A Phase II Study to Assess the Efficacy, Safety and Tolerability of VAL401 in the Treatment of Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) After Failure of at Least One Prior Chemotherapeutic Regimen
The objectives of this study are to assess the safety, tolerability, pharmacokinetics and efficacy of VAL401 in the treatment of patients with locally advanced or metastatic non-small cell lung adenocarcinoma.
Read the detailed description
This is a Phase II, open label study to assess the efficacy, safety and tolerability of VAL401 in the treatment of patients with locally advanced or metastatic non-small cell lung adenocarcinoma after failure of at least one prior chemotherapeutic regimen. Eligible patients will be enrolled as a single cohort and treated with VAL401, given as oral capsules. VAL401 is a formulation of Risperidone (active pharmaceutical ingredient) in a liquid lipid filled capsule.
- Conditions
- Carcinoma, Non-Small-Cell Lung, Adenocarcinoma
- Being tested
- VAL401
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAL401Drug
Also called Risperidone lipid formulation
Risperidone formulated into a liquid lipid filled capsule
| Study group | Role | What they receive |
|---|---|---|
| VAL401 treatment | Experimental | Patients received VAL401 oral formulation once daily according to their level of tolerance (2 mg - 10 mg). Receives: Drug: VAL401 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
PFS is defined as the time from screening to disease progression (or death if the patient died before progression), with progression date nominally defined as the date the patient was withdrawn from the trial, where the Principal Investigator has determined by their professional discretion the patient has symptomatic disease progression.
Measured: 6 months
Secondary outcomes (7)
Patient Quality of Life During VAL401 Treatment
Changes in patient quality of life measured by EORTC Health-related Quality of Life (HRQoL) assessment questionnaire QLQ-C30 (Cancer specific questionnaire).
Measured: 6 months
Number of Participants Reporting Adverse Events and Serious Adverse Events
Ongoing evaluation of Adverse Events during treatment with VAL401. Events assessed for number of patients affected, severity of event, likelihood of event being related to the drug treatment and whether the event is an expected/known side effect of Risperidone.
Measured: 6 months
Number of Patients With Disease Control
Objective tumour response rates according to RECIST 1.1 for target lesions and assessed by CT:
Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Measured: 6 months
Peak Plasma Concentration (Cmax)
Assessment of Cmax in collected blood samples on Day 1 and Day 15 of Cycle 1, collected at time points: pre-dose (0h) then 10, 15, 30 minutes, 1, 2, 4, 8, 10 and 24 hours after administration of VAL401.
Measured: 1 Day and 2 weeks
Trough Plasma Concentration (Cmin)
Assessment of trough plasma concentration (Cmin) in collected blood samples on Day 1 and Day 15 of Cycle 1, collected at time points: pre-dose (0h) then 10, 15, 30 minutes, 1, 2, 4, 8, 10 and 24 hours after administration of VAL401.
Measured: 1 Day and 2 weeks
Plasma VAL401 Half-life (t 1/2)
Assessment of plasma half-life of VAL401 (t 1/2) in collected blood samples on Day 1 and Day 15 of Cycle 1, collected at time points: pre-dose (0h) then 10, 15, 30 minutes, 1, 2, 4, 8, 10 and 24 hours after administration of VAL401.
Measured: 1 Day and 2 weeks
Overall Survival
Defined as the time from screening to death if the patient dies within the period that the site is open
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study startOct 2016
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Carcinoma, Non-Small-Cell LungStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- ValiSeek Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875340
- Sponsor's protocol ID
- VAL401-001
- Status last verified
- Sep 2018
- First submitted
- 15 Aug 2016
- Last updated
- 15 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified patient data will be made available on primary and secondary endpoints within 12 months of database lock.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Assess the Efficacy, Safety and Tolerability of VAL401 in the Treatment of Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) After Failure of at Least One Prior Chemotherapeutic Regimen
- ClinicalTrials.gov ID
- NCT02875340
- Acronym / sponsor ID
- VAL401-001
- Conditions
- Carcinoma, Non-Small-Cell Lung, Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- ValiSeek LimitedIndustry (pharma, biotech, devices)
- Study start
- Oct 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 23 Aug 2016 (estimated)
- Results
- Posted 15 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are to assess the safety, tolerability, pharmacokinetics and efficacy of VAL401 in the treatment of patients with locally advanced or metastatic non-small cell lung adenocarcinoma.
Detailed description
This is a Phase II, open label study to assess the efficacy, safety and tolerability of VAL401 in the treatment of patients with locally advanced or metastatic non-small cell lung adenocarcinoma after failure of at least one prior chemotherapeutic regimen. Eligible patients will be enrolled as a single cohort and treated with VAL401, given as oral capsules. VAL401 is a formulation of Risperidone (active pharmaceutical ingredient) in a liquid lipid filled capsule.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VAL401 treatment | Experimental | Drug: VAL401Patients received VAL401 oral formulation once daily according to their level of tolerance (2 mg - 10 mg). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pathologically confirmed diagnosis of Stage IIIB or Stage IV adenocarcinoma of the lung. Patients with mixed histology will be eligible if adenocarcinoma is the predominant histology.
- Measurable disease according to RECIST version 1.1.
- Prior chemotherapy for relapsed or metastatic non small cell lung cancer.
- Life expectancy of at least 3 months.
- Negative human chorionic gonadotropin (hCG) test in women of childbearing potential (defined as women ≤ 50 years of age or history of amenorrhea for ≤ 12 months prior to study screening). Sexually active male and female patients of childbearing potential must agree to use an effective method of birth control e.g. barrier methods with spermicides, oral or parenteral contraceptives and/or intrauterine devices, during the entire duration of the study and for 1 month after the final administration of VAL401. Note that female patients may be surgically sterile (with appropriate documentation in the patient's medical records).
Key exclusion criteria (10 listed)
- Radiotherapy or surgery (other than biopsy) within 4 weeks prior to Cycle 1 Day 1.
- Any chemotherapy regimens (including investigational agents) with delayed toxicity with 6 weeks of Cycle 1 Day 1, or received any chemotherapy regimens given continuously or on a weekly basis which have limited potential for delayed toxicity within 2 weeks prior to Cycle 1 Day 1. Palliative treatment regimens, and other concomitant drugs regimens are permitted with stable toxicity, and recording of all concomitant medications (including herbal).
- Pregnant or lactating female patients.
- Active hepatitis B or C or other active liver disease (other than malignancy).
- Any active, clinically significant, viral, bacterial, or systemic fungal infection within 2 weeks prior to Cycle 1 Day 1; other than cytomegalovirus which may be present providing any required concomitant anti-viral treatment is recorded appropriately.
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 |
|---|---|---|
| VAL401Also: Risperidone lipid formulationRisperidone formulated into a liquid lipid filled capsule | Drug | VAL401 treatment |
Primary outcome
Progression-free Survival (PFS)
Time frame: 6 months
PFS is defined as the time from screening to disease progression (or death if the patient died before progression), with progression date nominally defined as the date the patient was withdrawn from the trial, where the Principal Investigator has determined by their professional discretion the patient has symptomatic disease progression.
7 secondary outcomes
Patient Quality of Life During VAL401 Treatment
Time frame: 6 months
Number of Participants Reporting Adverse Events and Serious Adverse Events
Time frame: 6 months
Number of Patients With Disease Control
Time frame: 6 months
Peak Plasma Concentration (Cmax)
Time frame: 1 Day and 2 weeks
Trough Plasma Concentration (Cmin)
Time frame: 1 Day and 2 weeks
Plasma VAL401 Half-life (t 1/2)
Time frame: 1 Day and 2 weeks
Overall Survival
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified patient data will be made available on primary and secondary endpoints within 12 months of database lock.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VAL401 in people with Carcinoma, Non-Small-Cell Lung and Adenocarcinoma, run by ValiSeek Limited.
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 7 inclusion and 10 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: finished, as of the sponsor's last update on 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) (time frame: 6 months). 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 15 Oct 2018.