Trial · NCT02875340
A Study of VAL401 in the Treatment of Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
NCT02875340, Phase 2, Completed, ValiSeek Limited; results first posted 2018-10-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of VAL401 in the Treatment of Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer. Trials, record NCT02875340. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02875340
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of VAL401 in the Treatment of Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
- NCT number
- NCT02875340
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- ValiSeek Limited
- Conditions
- Carcinoma, Non-Small-Cell Lung, Adenocarcinoma
- Interventions
- VAL401
- First posted
- 2016-08-23
- Last updated
- 2018-10-15
- Results first posted
- 2018-10-15
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | 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(or death if the patient died before progression), with progression date nominally defined as the date the patient was withdrawn from the trial, where the Principal Investigator has determined by their professional discretion the patient has symptomatic disease progression. |
| Secondary | Patient Quality of Life During VAL401 Treatment | 6 months | Changes in patient quality of life measured by EORTC Health-related Quality of Life (HRQoL) assessment questionnaire QLQ-C30 (Cancer specific questionnaire). |
| Secondary | Number of Participants Reporting Adverse Events and Serious Adverse Events | 6 months | 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. |
| Secondary | Number of Patients With Disease Control | 6 months | 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. |
| Secondary | Peak Plasma Concentration (Cmax) | 1 Day and 2 weeks | 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. |
| Secondary | Trough Plasma Concentration (Cmin) | 1 Day and 2 weeks | 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. |
| Secondary | Plasma VAL401 Half-life (t 1/2) | 1 Day and 2 weeks | 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. |
| Secondary | Overall Survival | 6 months | Defined as the time from screening to death if the patient dies within the period that the site is open |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) | 6 months | weeks | MEAN | |
| SECONDARY | Patient Quality of Life During VAL401 Treatment | 6 months | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Reporting Adverse Events and Serious Adverse Events | 6 months | Total number of patients reporting Adverse Events or Serious Adverse Events (excluding death) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With Disease Control | 6 months | 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). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Peak Plasma Concentration (Cmax) | 1 Day and 2 weeks | 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. | ng/mL | MEAN |
| SECONDARY | Trough Plasma Concentration (Cmin) | 1 Day and 2 weeks | 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. | ng/mL | MEAN |
| SECONDARY | Plasma VAL401 Half-life (t 1/2) | 1 Day and 2 weeks | 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. | hours | MEAN |
| SECONDARY | Overall Survival | 6 months | weeks | MEAN |
Source ClinicalTrials.gov
Results by group66
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) | VAL401 Treatment - Intention to Treat Group | 5.2 | Full Range 0.4 to 11.6 | weeks | |
| Progression-free Survival (PFS) | VAL401 Treatment - Per Protocol Group | 7.2 | Full Range 4.0 to 11.6 | weeks | |
| Patient Quality of Life During VAL401 Treatment | VAL401 Treatment | ECOG data / Not measured | 4 | Participants | |
| Patient Quality of Life During VAL401 Treatment | VAL401 Treatment | ECOG data / Status maintained | 3 | Participants | |
| Patient Quality of Life During VAL401 Treatment | VAL401 Treatment | ECOG data / Status deteriorated | 1 | Participants | |
| Patient Quality of Life During VAL401 Treatment | VAL401 Treatment | ECOG data / Status improved | 0 | Participants | |
| Patient Quality of Life During VAL401 Treatment | VAL401 Treatment | Improvement in pain / Not measured | 2 | Participants | |
| Patient Quality of Life During VAL401 Treatment | VAL401 Treatment | Improvement in pain / Status maintained | 2 | Participants | |
| Patient Quality of Life During VAL401 Treatment | VAL401 Treatment | Improvement in pain / Status deteriorated | 0 | Participants | |
| Patient Quality of Life During VAL401 Treatment | VAL401 Treatment | Improvement in pain / Status improved | 4 | Participants |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | VAL401 Treatment | 8 | |
| Overall Study | COMPLETED | VAL401 Treatment | 0 | |
| Overall Study | NOT COMPLETED | VAL401 Treatment | 8 |
Source ClinicalTrials.gov
Adverse events24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fatigue | Social circumstances | VAL401 Treatment | 6 | 8 | 9 |
| other | Vertigo | Nervous system disorders | VAL401 Treatment | 3 | 8 | 3 |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | VAL401 Treatment | 2 | 8 | 2 |
| other | Sleepiness | Social circumstances | VAL401 Treatment | 2 | 8 | 6 |
| other | Nervousness | Nervous system disorders | VAL401 Treatment | 2 | 8 | 2 |
| other | Excitement | Nervous system disorders | VAL401 Treatment | 2 | 8 | 2 |
| other | Agression | Nervous system disorders | VAL401 Treatment | 2 | 8 | 2 |
| other | Atrial fibrillation | Cardiac disorders | VAL401 Treatment | 1 | 8 | 1 |
| other | Bifasicular block | Cardiac disorders | VAL401 Treatment | 1 | 8 | 1 |
| other | Supraventricular extrasystole | Cardiac disorders | VAL401 Treatment | 1 | 8 | 1 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | VAL401 Treatment | 3 | 8 |
| Total, other adverse events | VAL401 Treatment | 8 | 8 |
| Total, serious adverse events | VAL401 Treatment | 1 | 8 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02875340
GET https://conductscience.org/api/trials/v1/NCT02875340/results?page=2