Lung adenocarcinoma chemotherapy naive or recurrent for which vinorelbine/cisplatin would be appropriate therapy MedDRA version: 20.0 Level: PT Classification code 10025031 Term: Lung adenocarcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Helix BioPharma Corp
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female aged = 18 years old 2. Histologically confirmed lung adenocarcinoma, classified as: - Chemotherapy-naive patients with metastatic lung adenocarcinoma for whom vinorelbine/cisplatin would be appropriate therapy; - Metastatic recurrent lung adenocarcinoma following prior surgery, radiation and/or adjuvant chemotherapy at least 6 months ago, for whom vinorelbine/cisplatin would be appropriate therapy; - Staging must be assessed according to TNM, 8th edition and based on computed tomography (CT) scan; - Grade 1 – 4 adenocarcinoma. 3. No prior adjuvant chemotherapy within 6 months of the first treatment day if there is recurrent disease 4. At least a single measurable lesion in accordance with the RECIST v1.1 criteria 5. Eastern Cooperative Oncology Group (ECOG) performance status: 0-1 6. A life expectancy of = 3 months 7. Adequate organ function as determined by the following criteria: - Absolute neutrophil count (ANC) = 1.5 × 109/L - Platelet count = 100 × 109/L - Haemoglobin (HGB) = 9 g/dL - Creatinine clearance = 60 mL/min calculated using the Cockcroft-Gault Formula and serum creatinine = 1.5 × the upper limit of normal (ULN) - Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) = 3 × ULN or =65 years) yes F.1.3.1 Number of subjects for this age range 58
Exclusion criteria
Exclusion criteria: 1. Pregnant or nursing mother 2. Prior history of other malignancies with the exception of non-melanoma skin cancer 3. Patients with a known positive Epidermal Growth Factor Receptor (EGFR) mutation or whose tumour harbour an anaplastic lymphoma kinase (ALK) translocation 4. Active central nervous system metastasis and/or leptomeningeal disease (known or suspected); Patients with asymptomatic brain metastases are eligible if they had local therapy more than 1 month before enrolment 5. Evidence of active infection 6. Received treatment in another clinical study within the 30 days before commencing study drug and have not recovered from side effects of a study drug, except for alopecia 7. A serious uncontrolled medical condition 8. Known positive human immunodeficiency virus (HIV), known hepatitis B surface antigen, or hepatitis C positive 9. Sustained QT interval corrected for heart rate (QTc) with Fridericia’s correction > 450 msec at Screening, or a history of additional risk factors for Torsades de pointes (e.g., heart failure, hypokalaemia, family history of long QT syndrome) 10. Pre-existing peripheral neuropathy Grade =1 CTCAE (v. 4.03) 11. Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent or compliance with the requirements of the protocol 12. Received chemotherapy during the 30 days before study treatment start; are receiving radiotherapy, targeted therapy, hormonal therapy, immunotherapy, major surgery or other study drugs during the 4 weeks before study treatment start, and have not recovered from all treatment related toxicities to Grade = 1, except for alopecia. (Radiotherapy is allowed for the symptomatic treatment of bone metastases.) 13. Taking systemic steroids (other than inhalers or topical steroids) or other medication to suppress the immune system 14. Participating (or planning to participate) in any other clinical trial during this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine: • Safety and tolerability of L-DOS47 in combination treatment with vinorelbine/cisplatin • Dose limiting toxicities (DLTs) of L-DOS47 in combination treatment with vinorelbine/cisplatin • Maximum tolerated dose (MTD) and recommended Part 2 dose of L-DOS47 in combination treatment with vinorelbine/cisplatin • Preliminary efficacy of L-DOS47 by comparing the time to disease progression (TTP) of L-DOS47 in combination with vinorelbine/cisplatin to vinorelbine/cisplatin alone in patients with lung adenocarcinoma;Secondary Objective: • Determine the preliminary efficacy of L-DOS47 by comparing the objective response rate (ORR) of L-DOS47 in combination with vinorelbine/cisplatin to vinorelbine/cisplatin alone in patients with lung adenocarcinoma (Response Evaluation Criteria in Solid Tumours [RECIST] version 1.1 criteria will be used to determine the objective response rate.) • Compare the safety and tolerability of L-DOS47 in combination with vinorelbine/cisplatin to vinorelbine/cisplatin alone in patients with lung adenocarcinoma • Compare the overall survival (OS) of patients administered L-DOS47 in combination with vinorelbine/cisplatin to patients administered vinorelbine/cisplatin alone;Primary end point(s): The primary endpoint is time to disease progression.;Timepoint(s) of evaluation of this end point: Time to disease progression will be analysed using Kaplan-Meier survival estimates. Follow-up for disease progression will be conducted by radiologic assessments every 6 weeks (± 7 days) until one of the following occurs: disease progression, patient initiates non-study cancer treatment, patient withdraws consent, or becomes lost-to-follow-up; | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints include: • Objective response as measured using RECIST defined as the proportion of patients with a best overall response of complete response and partial response • Overall survival • Safety and tolerability of L-DOS47 in combination with vinorelbine/cisplatin ;Timepoint(s) of evaluation of this end point: Follow-up for disease progression will be conducted by radiologic assessments every 6 weeks (± 7 days) until one of the following occurs: disease progression, patient initiates non-study cancer treatment, patient withdraws consent, or becomes lost-to-follow-up; Survival data will be captured by telephone call every 30 days (± 7 days) and patients will be followed until death | — |
Countries
Hungary, Poland, Ukraine
Contacts
Public ContactClinical Operations
Helix BioPharma Corp.
Outcome results
None listed