A Phase 2, Open-Label Study of Orally Administered PAX-1 Therapy in Patients with Brain Metastases (BM) Secondary to Non-Small Cell Lung Cancer (NSCLC)
- Conditions
- Neoplasms
- Registration Number
- KCT0005636
- Lead Sponsor
- ovotech Asia Korea
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 76
Inclusion Criteria:
All patients enrolling into the study must meet all the following inclusion criteria:
1.Willing to sign written informed consent
2.Histological or cytological confirmation advanced NSCLC (stage IV) with radiologically documented BM. Contrast-enhanced magnetic resonance imaging (MRI) or computed tomography (CT) confirmed BM with at least one measurable lesion (according to RANO -BM and RECIST v1.1)
3. Patients with asymptomatic BM secondary to NSCLC who are intolerant to standard treatment or resistant to standard therapy (per NCCN guidelines) or for whom curative therapy is no longer an option
4. Age = 18 years at time of study entry (or age of legal consent, whichever is older)
5. ECOG performance status = 2 i.e., 0, 1 or 2
6. Body weight >30kg
7.Life expectancy of at least 3 months
8.Adequate hematology laboratory data within 6 weeks prior to start of treatment: absolute neutrophils > 1.5 x 10 9/L, platelets = 100 x 109/L, hemoglobin = 9 g/dL
9. Adequate biochemistry laboratory data within 6 weeks prior to start of treatment: Total bilirubin = 1.5 x upper limit of normal (ULN) (except patient with confirmed Gilbert's syndrome or liver metastasis: total bilirubin = 3 ULN), transaminases = 2.5 x ULN or = 5.0 x ULN for patients with documented liver metastases, alkaline phosphatases = 5 x ULN, creatinine clearance > 40 mL/min (Cockcroft), albumin > 24 g/L, serum magnesium 0.70~1.10 mmol/L, serum potassium 3.5~5.2 mmol/L
10.Women should be post-menopausal or willing to accept the use of an effective contraceptive regimen during the treatment period and at least 3 months after the end of the study treatment. All non-menopausal women should have a negative pregnancy test within 72 hours prior to registration. Men should accept to use an effective contraception during treatment period and at least 3 months after the end of the study treatment
11.Patient willing and able to comply with the protocol for the duration of the study including undergoing treatment and examinations including follow-up as per scheduled visits
Exclusion Criteria:
Any of the following criteria will exclude patients from study participation:
1. Central nervous system (CNS) complications for which urgent neurosurgical intervention is indicated (e.g., resection, shunt placement)
2. Known leptomeningeal metastases
3.Patient unable to have MRI or CT for any reason (e.g., due to pacemaker, ferromagnetic implants, claustrophobia, extreme obesity, allergic reactions to contrast agents used for CT)
4.Known history of elevated risks for torsade de point (TdP), such as hyperkalemia, or family history of long QT syndrome.
5.Any of the following cardiac abnormalities:
•Unstable angina pectoris,
•Congestive heart failure = New York Heart Association (NYHA) Class 3, or
•ECG evidence of a QT interval with Frederica’s correction (QTcF) > 450 ms in males and > 470 ms in females
6.Any unresolved toxicity National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade =2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
7.Participation in another therapeutic trial within the 30 days prior to entering this study (participation in a survival follow -up period of a clinical study is not an exclusion criterion)
8.Patients known or suspected to have hypersensitivities, allergies to sodium meta-arsenite, related compounds or any of the excipients of the IP
9.Current or prior use of immunosuppressive medication within 14 days before the first fraction of RT (exception: systemic corticosteroids at physiologic doses not exceeding 10 mg/day of prednisone or equivalent are allowed as well as steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) -Topical, inhaled, nasal and ophthalmic steroids are not prohibited).
10.Known primary immunodeficiency or active human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies)
11.Known active or chronic viral hepatitis or history of any type of hepatitis within the last 6 months indicated by positive test for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) anti body test
12. History of active tuberculosis (TB) (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in-line with local practice)
13. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of IP
14. Patients with an inability to comply with study procedures or any condition which in the Investigator's opinion makes the patient unsuitable for study participation.
15. History or evidence of any other clinically significant condition that, in the opinion of the Investigator, would pose a risk to patient safety or interfere with study procedures, evaluation or completion.
16. Inability to swallow oral medications or pre-existing gastrointestinal disorders that might interfere with proper absorption of oral drugs.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Efficacy Endpoints (Arm A): Evaluation based on RANO-BM (Response Assessment in Neuro-Oncology Brain Metastases) criteria for BM(Brain Metastases): • Intracranial ORR(objective response rate ) (defined as confirmed CR(Complete response ) or PR(Partial response )) or SD(stable disease )) • DCR (confirmed CR(Complete response ), PR (Partial response )?? SD(stable disease)) at 3 months
- Secondary Outcome Measures
Name Time Method