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

NCT02875340 | Completed Phase 2 Results

• 1 other identifier: VAL401-001
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Carcinoma, Non-Small-Cell Lung; Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

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(or death if the patient died before progression), with progression date nominally defined as the date the patient was withdrawn from the trial, where the Principal Investigator has determined by their professional discretion the patient has symptomatic disease progression.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

Secondary Outcomes (7)

• Patient Quality of Life During VAL401 Treatment

  6 months

• Number of Participants Reporting Adverse Events and Serious Adverse Events

  6 months

• Number of Patients With Disease Control

  6 months

• Peak Plasma Concentration (Cmax)

  1 Day and 2 weeks

• Trough Plasma Concentration (Cmin)

  1 Day and 2 weeks

Study Arms (1)

VAL401 treatment

EXPERIMENTAL

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

Drug: VAL401

Interventions

VAL401 DRUG

Risperidone formulated into a liquid lipid filled capsule

Also known as: Risperidone lipid formulation

VAL401 treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• ValiSeek Limited: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Adenocarcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

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.

Results Point of Contact

• Title: Suzanne Dilly
• Organization: ValiSeek Limited

suzanne.dilly@valirx.com

+442030084416

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2016
• First Posted: August 23, 2016
• Study Start: October 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: October 15, 2018
• Results First Posted: October 15, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share