Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Adenocarcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Central Nervous System Depressants

Psychotropic Drugs

All Drugs and Chemicals

Cardiotonic Agents

Risperidone

Serotonin

Neurotransmitter Agents

Antipsychotic Agents

Dopamine

Dopamine Antagonists

Dopamine Agents

Patients received VAL401 oral formulation once daily according to their level of tolerance (2 mg - 10 mg).

Risperidone formulated into a liquid lipid filled capsule

VAL401

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.

A Study of VAL401 in the Treatment of Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

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

De-identified patient data will be made available on primary and secondary endpoints within 12 months of database lock.

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(or death if the patient died before progression), with progression date nominally defined as the date the patient was withdrawn from the trial, where the Principal Investigator has determined by their professional discretion the patient has symptomatic disease progression.

Changes in patient quality of life measured by EORTC Health-related Quality of Life (HRQoL) assessment questionnaire QLQ-C30 (Cancer specific questionnaire).

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.

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.

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.

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.

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.

Defined as the time from screening to death if the patient dies within the period that the site is open

ValiSeek Limited

Patients received VAL401 oral formulation once daily according to their level of tolerance (2 mg - 10 mg)

VAL401 Treatment

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Georgia

Region of Enrollment

Smokers

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.

Suzanne Dilly

Patients received VAL401 oral formulation once daily according to their level of tolerance (2 mg - 10 mg).

This group includes all patients who completed screening, but excludes the one patient for whom the date of diagnosis is inconsistent.

VAL401 Treatment - Intention to Treat Group

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.

VAL401 Treatment - Per Protocol Group

Progression-free Survival (PFS)

ECOG data

Improvement in pain

Improvement in Insomnia

Improvement in lack of appetite

Improvement in nausea/vomiting

Improvement in fatigue

Improvement in irritability

Improvement in depression

Improvement in anxiety

Improvement in diarrhoea

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.

Patient Quality of Life During VAL401 Treatment

Adverse Events reported

Serious Adverse Events Reported

Total number of patients reporting Adverse Events or Serious Adverse Events (excluding death)

Number of Participants Reporting Adverse Events and Serious Adverse Events

Participants receiving mid-treatment CT scan

Primary target tumour increased by 10% or less

Participants demonstrating Complete Response

Participants demonstrating Partial Response

Participants demonstrating Progressive disease

Participants demonstrating Stable Disease

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).

Number of Patients With Disease Control

VAL401 Treatment - Day 1

Pharmacokinetic measurements taken on Day 15 of dosing on 2 mg daily dose level

VAL401 Treatment - Day 15 (2 mg)

Pharmacokinetic measurements taken on Day 15 of dosing on 6 mg daily dose level

VAL401 Treatment - Day 15 (6 mg)

Pharmacokinetic measurements taken on Day 15 of dosing on 8 mg daily dose level

VAL401 Treatment - Day 15 (8 mg)

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.

Peak Plasma Concentration (Cmax)

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of VAL401 in the Treatment of Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer	NCT02875340	Carcinoma, Non-... Adenocarcinoma	VAL401	18 Years -	ValiSeek Limited
A Study of VAL401 in the Treatment of Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer	NCT02875340	Carcinoma, Non-... Adenocarcinoma	VAL401	18 Years -	ValiSeek Limited
A Study of VAL401 in the Treatment of Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer	NCT02875340	Carcinoma, Non-... Adenocarcinoma	VAL401	18 Years -	ValiSeek Limited

Spots Global Cancer Trial Database for val401

Every month we try and update this database with for val401 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for val401

Every month we try and update this database with for val401 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for val401 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.