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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VAL401 treatment | Experimental | Patients received VAL401 oral formulation once daily according to their level of tolerance (2 mg - 10 mg). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VAL401 | Drug | Risperidone formulated into a liquid lipid filled capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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(or death if the patient died before progression), with progression date nominally defined as the date the patient was withdrawn from the trial, where the Principal Investigator has determined by their professional discretion the patient has symptomatic disease progression. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6 months |
| Number of Participants Reporting Adverse Events and Serious Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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De-identified patient data will be made available on primary and secondary endpoints within 12 months of database lock.
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Recruitment period: 31 October 2016 - 19 June 2017
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| ID | Title | Description |
|---|---|---|
| FG000 | VAL401 Treatment | Patients received VAL401 oral formulation once daily according to their level of tolerance (2 mg - 10 mg) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | VAL401 Treatment | Patients received VAL401 oral formulation once daily according to their level of tolerance (2 mg - 10 mg) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Full Range | weeks | 6 months |
|
Adverse Event data collected from time of screening until patient final visit (up to 6 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VAL401 Treatment | Patients received VAL401 oral formulation once daily according to their level of tolerance (2 mg - 10 mg) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | Social circumstances | Non-systematic Assessment |
The study initially planned to recruit up to 20 patients, but closed recruitment at 8 patients due to operational challenges, and the limitations of data coming in, due to frailty of end stage cancer patients.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Suzanne Dilly | ValiSeek Limited | +442030084416 | suzanne.dilly@valirx.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 22, 2016 | Jul 27, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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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. |
| 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. | 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. | 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. | 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. | 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 | 6 months |
| Adverse Event |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Smokers | Count of Participants | Participants |
|
Patients received VAL401 oral formulation once daily according to their level of tolerance (2 mg - 10 mg). This groups excludes the 2 patients received treatment for less than 10 days, as well as the patient for whom the date of diagnosis is inconsistent. |
|
|
| Secondary | 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). | Each question is scored on a scale of 1 to 4, with each patient assessed for improvement or deterioration of Quality of Life for each life category stated. The number of patients, improving, deteriorating or remaining stable for each measure is reported out of the total of 8 patients assessed. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | 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. | Total number of patients reporting Adverse Events or Serious Adverse Events (excluding death) | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | 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. | Participants scheduled to receive scans at screening, 3 months and 6 months. 2 participants attended CT scans at 3 months, or at their final visit (if earlier). | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | 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. | Pharmacokinetic measurements include total of Risperidone plus metabolite 9-hydroxy-Risperidone as "total actives" Note: 3 out of 8 patients completed PK analysis at Day 15, the remaining 5 patients did not undergo Day 15 PK analysis due to protocol deviations or early withdrawal from the trial. | Posted | Mean | Full Range | ng/mL | 1 Day and 2 weeks |
|
|
|
| Secondary | 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. | Pharmacokinetic measurements include total of Risperidone plus metabolite 9-hydroxy-Risperidone as "total actives". Note: 3 out of 8 patients completed PK analysis at Day 15, the remaining 5 patients did not undergo Day 15 PK analysis due to protocol deviations or early withdrawal from the trial. | Posted | Mean | Full Range | ng/mL | 1 Day and 2 weeks |
|
|
|
| Secondary | 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. | Pharmacokinetic measurements include total of Risperidone plus metabolite 9-hydroxy-Risperidone as "total actives". Note: 3 out of 8 patients completed PK analysis at Day 15, the remaining 5 patients did not undergo Day 15 PK analysis due to protocol deviations or early withdrawal from the trial. | Posted | Mean | Full Range | hours | 1 Day and 2 weeks |
|
|
|
| Secondary | Overall Survival | Defined as the time from screening to death if the patient dies within the period that the site is open | Posted | Mean | Full Range | weeks | 6 months |
|
|
|
| 3 |
| 8 |
| 1 |
| 8 |
| 8 |
| 8 |
| Vertigo | Nervous system disorders | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Sleepiness | Social circumstances | Non-systematic Assessment |
|
| Nervousness | Nervous system disorders | Non-systematic Assessment |
|
| Excitement | Nervous system disorders | Non-systematic Assessment |
|
| Agression | Nervous system disorders | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
|
| Bifasicular block | Cardiac disorders | Non-systematic Assessment |
|
| Supraventricular extrasystole | Cardiac disorders | Non-systematic Assessment |
|
| Ventricular extrasystole | Cardiac disorders | Non-systematic Assessment |
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| Ventricular tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Peripheral venous thrombosis | Vascular disorders | Non-systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Chest pain | Cardiac disorders | Non-systematic Assessment |
|
| Pericardial effusion | Vascular disorders | Non-systematic Assessment |
|
| Pleural effusion | Vascular disorders | Non-systematic Assessment |
|
| Arthalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| ALP rise | Hepatobiliary disorders | Non-systematic Assessment |
|
| Left lower extremity edema | Vascular disorders | Non-systematic Assessment |
|
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| Status improved |
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| Improvement in pain |
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| Improvement in Insomnia |
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| Improvement in lack of appetite |
|
| Improvement in nausea/vomiting |
|
| Improvement in fatigue |
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| Improvement in irritability |
|
| Improvement in depression |
|
| Improvement in anxiety |
|
| Improvement in diarrhoea |
|
| Number participants reporting no events |
|
| Title | Measurements |
|---|---|
|
| Participants demonstrating Partial Response |
|
| Participants demonstrating Progressive disease |
|
| Participants demonstrating Stable Disease |
|