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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02340208 |
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Date of registration:
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13/01/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Phase I/II Open-Label, Non-Randomized Dose Escalation Study of Immunoconjugate L-DOS47
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Scientific title:
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A Phase I/II Open-Label, Non-Randomized Dose Escalation Study of Immunoconjugate L-DOS47 as a Monotherapy in Non-Squamous Non-Small Cell Lung Cancer Patients |
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Date of first enrolment:
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May 2012 |
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Target sample size:
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76 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02340208 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Poland
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Contacts
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Name:
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Dariusz Kowalski, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Maria Sklodowska-Curie Memorial Cancer Centre & Institute of Oncology |
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Key inclusion & exclusion criteria
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Main Inclusion Criteria:
Patients will be entered in the study only if they meet all of the following criteria:
1. Male or female aged = 18 years old
2. Have histologically confirmed non-squamous NSCLC that are:
1. Chemo naïve Stage IIIb or IV non-squamous NSCLC who are not candidates for
chemotherapy or radiotherapy, or who refused standard therapy
2. 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.)
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 bone marrow, renal and liver function
Main Exclusion Criteria:
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 drug 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 (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 neuropathy = 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 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.)
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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Non-Small Cell Lung Cancer
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Intervention(s)
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Drug: L-DOS47
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Primary Outcome(s)
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The incidence and severity of drug-related adverse events as a measure of safety and tolerability of L-DOS47
[Time Frame: Up to 12 weeks]
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Secondary Outcome(s)
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The evaluation of anti-L-DOS47 antibody over time
[Time Frame: Up to 12 weeks]
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Changes from baseline for additional safety parameters (clinical laboratory assessments, vital signs, weight, oxygen requirement and 12-lead ECG)
[Time Frame: Up to 12 weeks]
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L-DOS47 related toxicity during the first 2 hours after infusion
[Time Frame: During the first 2 hours after infusion]
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The incidence and severity of all reported adverse events and serious adverse events
[Time Frame: Participants will be followed for 12 weeks and the 30 day follow-up period]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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