A study to determine the safety of a new drug to treat non-squamous non-small cell lung cancer

Phase 1

Conditions: Therapeutic area: Diseases [C] - Cancer [C04]
MedDRA version: 20.0Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Inoperable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer

Registration Number: EUCTR2010-020729-42-PL

Lead Sponsor: Helix BioPharma Corp

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 76

Inclusion Criteria

1. Male or female aged = 18 years old
2. Have histologically confirmed non-squamous NSCLC. (If available at the site, the paraffin-fixed biopsy sample will be provided to the Sponsor.)
3. Have at least a single measurable lesion in accordance with the RECIST v1.1 criteria
4. Eastern Cooperative Oncology Group (ECOG) performance status: 0-2 5. Have a life expectancy of = 3 months
6. Have adequate organ function as determine by the following criteria:
a. Absolute neutrophil count = 1.5 x 1000000000/L
b. Platelet count = 100 x 1000000000/L
c. Haemoglobin (HGB) = 9 g/dL
d. Creatinine clearance = 60 mL/min calculated using the Cockcroft-Gault Formula or serum creatinine = 1.5 x upper limit of normal (ULN)
e. Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) = 3 x ULN, or < 5 x ULN if liver abnormalities are due to underlying malignancy
f. Total bilirubin = 1.5 x ULN.
Note: Blood transfusions administered for the sole purpose of meeting the study inclusion criteria between the time informed consent is signed and first dose of L-DOS47 is administered are not allowed.
7. Able to understand the information provided to them and to give written informed consent any study activities are conducted
8. Are willing and able to comply with scheduled visits, treatment plans, laboratory tests and other study procedures
9. Are not pregnant and do not plan to become pregnant during the study. Females of childbearing potential must provide a negative pregnancy test within the screening period (Day -21 to 0) and agree to use adequate contraception during the study and for a period of 90 days following the last dose of study treatment. Male patients and their female partners of child-bearing potential must agree to each use an approved form of contraception during the study and for a period of 90 days following the last dose. Adequate contraception includes oral or injectable (depot) oestrogen, and/or progestogen, or selective oestrogen receptor modulator contraceptive therapeutic, intrauterine contraceptive device or double barrier method (e.g., condom and diaphragm or spermicidal gel). Non-childbearing potential is defined as post-menopausal for at least 1 year or surgical sterilisation or hysterectomy at least 3 months before study start.
Pathway Specific Inclusion Criteria:
Staging of non-squamous NSCLC must be assessed according to TNM, 7th edition and based on computed tomography (CT) scan.
10. Patients are required to meet one of the following additional inclusion criteria:
a. Chemo-naïve Stage IIIb or IV non-squamous NSCLC who are not candidates for radiotherapy or who refused standard therapy.
b. Refractory Stage IIIb or IV non-squamous NSCLC.
(Staging of non-squamous NSCLC must be assessed according to TNM, 7th edition and based on computed tomography (CT) scan.)
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 42
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32

Exclusion Criteria

Patients will not be entered in the study for any of the following reasons:
1. Are pregnant or nursing mother
2. Have a prior history of other malignancies with the exception of non-melanoma skin cancer
3.Have known history of central nervous system (CNS) metastatic disease (previously treated or untreated)
4. Show evidence of active infection
5. Have received treatment in another clinical study within the 30 days before commencing study treatment or have not recovered from side effects of a study drug, except for alopecia
6. Have a serious uncontrolled medical condition
7. Known positive human immunodeficiency virus (HIV), known hepatitis B surface antigen, or hepatitis C positive
8. Sustained QTc (the QT interval corrected for heart rate) with Fridericia's correction > 450 ms at Screening or a history of additional risk factors for Torsades de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome)
9. Pre-existing peripheral neurophathy = CTC Grade 2
10. Have dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent or compliance with the requirements of the protocol
11. Are receiving chemotherapy during the 30 days before study start; receiving radiotherapy, targeted therapy, hormonal therapy, immunotherapy, major surgery or other study drugs during the 4 weeks before study treatment start or have not recovered from all treatment related toxicities to Grade = 1, except for alopecia. (Radiotherapy is allowed for the symptomatic treatment of bone metastases.)
12. Are taking systemic steroids (other than inhalers or topical steroids) or other medication to suppress the immune system
13. Are participating (or planning to participate) in any other clinical trial during this study.