Carcinoma, Non-Small-Cell Lung Clinical Trial
Official title:
A Phase I Single Dose Escalation Study of 131I-Sibrotuzumab in Patients With Advanced or Metastatic Non-small Cell Lung Cancer
NCT number | NCT02209727 |
Other study ID # | 1152.6 |
Secondary ID | |
Status | Terminated |
Phase | Phase 1 |
First received | August 5, 2014 |
Last updated | August 5, 2014 |
Start date | December 2000 |
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.
Status | Terminated |
Enrollment | 9 |
Est. completion date | |
Est. primary completion date | June 2002 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Boehringer Ingelheim |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determination of the dose limiting toxicity (DLT) | up to 12 weeks | No | |
Primary | Determination of the maximum tolerated dose (MTD) | MTD is defined as the highest dose below which two patients experience DLT | up to 12 weeks | No |
Primary | Occurrence of toxicity | graded according to the Common Toxicity Criteria (CTC) | up to 12 weeks | No |
Secondary | Maximum tumor response using the World Health Organisation (WHO) Disease Response Criteria | 8 weeks after therapeutic infusion | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04879849 -
A Study of TAK-676 With Pembrolizumab After Radiation Therapy to Treat a Number of Cancers
|
Phase 1 | |
Completed |
NCT04426825 -
A Study of Atezolizumab in Combination With Bevacizumab in Patients With EGFR Mutation Positive Stage IIIB-IV Non-Squamous Non-Small Cell Lung Cancer
|
Phase 2 | |
Terminated |
NCT03166631 -
A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread
|
Phase 1 | |
Completed |
NCT02810457 -
Evaluation of FKB238 and Avastin in Patients With Advanced/Recurrent Non-squamous Non-small Cell Lung Cancer
|
Phase 3 | |
Completed |
NCT02864394 -
Study of Pembrolizumab Versus Docetaxel in Participants Previously Treated for Non-Small Cell Lung Cancer (MK-3475-033/KEYNOTE-033)
|
Phase 3 | |
Recruiting |
NCT04592523 -
A Study of Usage of Brigatinib in the Treatment of Adult Participants for Approved Indications In South Korea
|
||
Recruiting |
NCT04838548 -
A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With EGFR-Positive Advanced Non-Small Cell Lung Cancer
|
Phase 2 | |
Recruiting |
NCT04077463 -
A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer
|
Phase 1 | |
Recruiting |
NCT05167604 -
Clinical Value of MRD Monitoring for Adjuvant Therapy in Postoperative NSCLC
|
||
Recruiting |
NCT04603807 -
A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in Participants With Advanced or Metastatic ROS1 Non-small Cell Lung Cancer (NSCLC) With and Without Central Nervous System (CNS) Metastases
|
Phase 3 | |
Completed |
NCT04948411 -
Durvalumab as Maintenance in Patients Who Received Chemoradiotherapy for Unresectable Stage III NSCLC: Real World Data From an Expanded Access Program in Brazil
|
||
Active, not recruiting |
NCT04487080 -
A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
|
Phase 3 | |
Not yet recruiting |
NCT04255836 -
Durvalumab Combined With Chemotherapy and Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Non-small Cell Lung Cancer (NSCLC)
|
Phase 2 | |
Completed |
NCT01953913 -
Afatinib (BIBW 2992) in Advanced Non-Small Cell Lung Cancer Patients With EGFR Mutation
|
Phase 3 | |
Recruiting |
NCT05715229 -
Immune Profile Selection By Fraction of ctDNA in Patients With Advanced NSCLC Treated With Immunotherapy
|
Phase 2 | |
Recruiting |
NCT04931654 -
A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer
|
Phase 1/Phase 2 | |
Suspended |
NCT05421936 -
Osimertinib for NSCLC With Uncommon EGFR Mutations
|
||
Completed |
NCT02847377 -
A Positron Emission Tomography (PET) Imaging Agent [18F]-ODS2004436 as a Marker of EGFR Mutation in Subjects With NSCLC
|
N/A | |
Completed |
NCT04427072 -
Study of Capmatinib Efficacy in Comparison With Docetaxel in Previously Treated Participants With Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation
|
Phase 3 | |
Recruiting |
NCT04823377 -
Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer.
|
N/A |