A Study of L-DOS47 in Combination With Vinorelbine/Cisplatin in Lung Adenocarcinoma

• Status: Terminated
• Trial end date: 2020-05-22
• Target enrollment: 0
• Participant gender: All

Summary

This study will determine the highest dose of L-DOS47 that can be given in combination with vinorelbine/cisplatin, evaluate safety and tolerability of L-DOS47 when given in combination with vinorelbine/cisplatin, and assess how effective this combination is in treating patients with lung adenocarcinoma compared to patients who are given vinorelbine/cisplatin alone.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Helix BioPharma Corporation
• Collaborator: KCR S.A.
• Treatments: Cisplatin; Immunoconjugates; Vinorelbine

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 assessed according to Tumor Node Metastases (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 × 10^9/L

• Platelet count ≥ 100 × 10^9/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 < 5 × ULN if liver abnormalities are due to underlying malignancy

• Total bilirubin ≤ 1.5 × 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.

8. Able to understand the information provided to them and to give written informed consent before any study activities are conducted

9. Willing and able to comply with scheduled visits, treatment plans, laboratory tests and other study procedures

10. 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 non-hormonal contraception (which includes but is not limited to double barrier or sexual abstinence) 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 of study treatment.

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

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. Receiving 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, 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.)

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