Status:
TERMINATED
A Dose Escalation Study of L-DOS47 in Recurrent or Metastatic Non-Squamous NSCLC
Lead Sponsor:
Helix BioPharma Corporation
Collaborating Sponsors:
Theradex
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The primary purpose of this research study is to evaluate how safe, how well tolerated and how effective a range of doses of L-DOS47 in combination with standard doublet therapy of pemetrexed/carbopla...
Detailed Description
It is planned that patients will receive 4 cycles of combination treatment with L-DOS47 + pemetrexed/carboplatin. Patients who have not progressed following the 4 cycles of combination treatment and w...
Eligibility Criteria
Inclusion
- Main
- Male or female patient ≥ 18 years of age
- Histologically or cytologically confirmed non-squamous NSCLC
- EGFR-mutation positive patients must have progressed on or had intolerance to an EGFR small molecule tyrosine kinase inhibitor
- Patients whose tumors harbor an anaplastic lymphoma kinase (ALK) translocation must have progressed on or had intolerance to an ALK inhibitor;
- No prior adjuvant chemotherapy within 1 year of the first treatment day if there is recurrent disease
- At least 1 site of measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and minimum life expectancy of ≥ 3 months
- Adequate bone marrow, renal and liver function
- Main
Exclusion
- Histologic evidence of predominantly squamous cell NSCLC
- Brain metastasis and/or leptomeningeal disease (known or suspected)
- Peripheral neuropathy \> CTCAE grade 1
- Possibility of a curative local treatment (surgery and/or radiotherapy)
- Previous chemotherapy except adjuvant treatment with progression of disease documented ≥ 12 months after end of adjuvant treatment
- Having received treatment in another clinical study within the 30 days prior to commencing study treatment or having side effects of a prior study drug that are not recovered to grade ≤ 1 or baseline, except for alopecia
- Concurrent chronic systemic immunotherapy, chemotherapy or hormone therapy
Key Trial Info
Start Date :
April 20 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2019
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT02309892
Start Date
April 20 2015
End Date
September 20 2019
Last Update
June 3 2024
Active Locations (2)
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1
University Hospitals Case Medical Center
Cleveland, Ohio, United States
2
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States