- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02209727
Single Dose Escalation Study of 131I-Sibrotuzumab in Patients With Advanced or Metastatic Non-small Cell Lung Cancer
August 5, 2014 updated by: Boehringer Ingelheim
A Phase I Single Dose Escalation Study of 131I-Sibrotuzumab in Patients With Advanced or Metastatic Non-small Cell Lung Cancer
Study to determine the maximum tolerated dose (MTD) and safety profile of a single-dose administration of sibrotuzumab (50 mg) conjugated to an increasing dose of 131 I isotope.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Evidence of advanced, non-resectable, and/or metastatic non-small cell lung cancer and at least one previous conventional treatment for advanced disease
- Eastern cooperative Oncology Group (ECOG) performance status of 0 or 1
- Measurable or evaluable disease, determined by World Health Organization (WHO) criteria using standard imaging modalities, including ultrasound, X-ray, CT and/or Magnetic Resonance Imaging (MRI). Bone scans and/or antibody scans are not to be used to determine the extent of the disease
- Expected survival of ≥ 16 weeks
- At least 18 years of age
- Platelet count ≥ 100 x 10**9/L
- Absolute neutrophil count ≥ 2.0 x 10**9/L
- Aspartate aminotransferase (AST) ≤ 3 x upper limit of normal or < 5 x upper limit of normal if liver metastases are present
- Total bilirubin ≤ 2mg/dL
- Serum creatinine ≤ 2mg/dL
- Ability to provide written informed consent
Exclusion Criteria:
- Known brain metastases
- Exposure to an investigational agent within 30 days prior to receiving the scout dose
- Incomplete recovery from surgery or incomplete healing of an incision site or evidence of infection
- Treatment with cytotoxic chemotherapy, radiation or immunosuppressive therapy within the 30 days (42 days for nitrosoureas and/or mitomycin C) of the scout infusion. Patients using inhaled corticosteroids are considered eligible for enrollment
- Serious illnesses, i.e., active infections requiring antibiotics, bleeding disorders or other serious illnesses precluding the use of either 131I or sibrotuzumab
- Women who are breast-feeding or pregnant
- Men and women who were sexually active and are unwilling to utilize a medically acceptable method of contraception
- Hypertrophic skin disease or autoimmune disease that possibly involves over-expression of fibroblast activation protein (FAP), which can be targeted by the antibody. These diseases include active inflammatory arthritis, cirrhosis, and keloids
- Unstable angina pectoris. Patients prescribed medication to control their angina pectoris must have been on a fixed dose for at least 1 month prior to screening to be eligible for trial enrollment
- Myocardial infarction within 3 months prior to screening
- New York Heart Association (NYHA) Heart failure stage III or IV, or a left ventricular ejection fraction of ≤ 40 %
- Impaired lung function, measured by a decrease in forced expiratory volume at one second (FEV1) to less than 50 % of the predicted normal value
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 131I-Sibrotuzumab
single therapy dose administered over 60 minutes at week 4
|
50 mg Sibrotuzumab conjugated with 131I
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determination of the dose limiting toxicity (DLT)
Time Frame: up to 12 weeks
|
up to 12 weeks
|
|
Determination of the maximum tolerated dose (MTD)
Time Frame: up to 12 weeks
|
MTD is defined as the highest dose below which two patients experience DLT
|
up to 12 weeks
|
Occurrence of toxicity
Time Frame: up to 12 weeks
|
graded according to the Common Toxicity Criteria (CTC)
|
up to 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum tumor response using the World Health Organisation (WHO) Disease Response Criteria
Time Frame: 8 weeks after therapeutic infusion
|
8 weeks after therapeutic infusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2000
Primary Completion (Actual)
June 1, 2002
Study Registration Dates
First Submitted
August 5, 2014
First Submitted That Met QC Criteria
August 5, 2014
First Posted (Estimate)
August 6, 2014
Study Record Updates
Last Update Posted (Estimate)
August 6, 2014
Last Update Submitted That Met QC Criteria
August 5, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1152.6
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Carcinoma, Non-Small-Cell Lung
-
National Cancer Institute (NCI)CompletedStage IIIA Non-Small Cell Lung Cancer | Recurrent Non-Small Cell Lung Carcinoma | Stage IV Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Bristol-Myers SquibbCompletedStage IIIA Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage I Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung Cancer | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung Carcinoma | Non-Squamous Non-Small...United States
-
National Cancer Institute (NCI)TerminatedStage IIIA Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
-
National Cancer Institute (NCI)Active, not recruitingLung Non-Squamous Non-Small Cell Carcinoma | Stage IB Lung Non-Small Cell Carcinoma AJCC v7 | Stage II Lung Non-Small Cell Cancer AJCC v7 | Stage IIA Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIB Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIIA Lung Non-Small Cell Cancer AJCC v7United States, Puerto Rico
-
Genelux CorporationNewsoara Biopharma Co., Ltd.Not yet recruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Advanced Non-squamous Non-small-cell Lung Cancer | Non-small Cell Lung Cancer Stage IV | Metastatic Squamous Non-Small Cell Lung Carcinoma | Non-small Cell Lung Cancer Recurrent | Metastatic Non-squamous Non Small Cell Lung Cancer and other conditions
-
National Cancer Institute (NCI)TerminatedStage IIIA Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
-
National Cancer Institute (NCI)CompletedStage IIIA Non-Small Cell Lung Cancer | Stage IIIB Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedStage IB Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIA Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIB Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIIA Lung Non-Small Cell Cancer AJCC v7 | Recurrent Lung Non-Small Cell Carcinoma | Stage IIIB Lung Non-Small Cell Cancer AJCC v7 | Stage IA...United States
-
University of Southern CaliforniaNational Cancer Institute (NCI); Society of Thoracic RadiologyActive, not recruitingStage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
-
M.D. Anderson Cancer CenterActive, not recruitingStage IB Lung Non-Small Cell Carcinoma AJCC v7 | Stage II Lung Non-Small Cell Cancer AJCC v7 | Stage IIA Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIB Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIIA Lung Non-Small Cell Cancer AJCC v7 | Stage I Lung Non-Small Cell Cancer AJCC v7 | Stage...United States
Clinical Trials on 131I-Sibrotuzumab
-
Boehringer IngelheimCompletedColorectal Neoplasms
-
Memorial Sloan Kettering Cancer CenterY-mAbs TherapeuticsAvailableCentral Nervous System/Leptomeningeal NeoplasmsUnited States
-
Centre Jean PerrinRecruiting
-
TransMolecularCompletedGlioma | Brain NeoplasmUnited States
-
Yale UniversityWithdrawn
-
TransMolecularUnknownAstrocytoma | Glioblastoma Multiforme | Malignant Glioma | GBM | OligodendrogliomaUnited States
-
Y-mAbs TherapeuticsTerminatedNeuroblastoma | Leptomeningeal Metastases | CNS MetastasesUnited States, Denmark, Japan, Spain
-
Children's Hospital of PhiladelphiaEli Lilly and Company; United States Department of DefenseNot yet recruitingCancer | Pediatric Cancer | Differentiated Thyroid Cancer | Cancer, Thyroid
-
TransMolecularTerminatedMelanoma | Metastatic Melanoma | Malignant MelanomaUnited States