A Study of VAL401 in the Treatment of Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
Condition: Carcinoma, Non-Small-Cell Lung; Adenocarcinoma
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: VAL401
Intervention description: Risperidone formulated into a liquid lipid filled capsule
Intervention MeSH terms: Risperidone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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             procedures with the understanding that the consent may be withdrawn by the patient at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.

        Exclusion Criteria:

          -  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.