Single Dose Escalation Study of 131I-Sibrotuzumab in Patients With Advanced or Metastatic Non-small Cell Lung Cancer

NCT ID: NCT02209727

Last Updated: 2014-08-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-12-31

Brief Summary

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

131I-Sibrotuzumab

single therapy dose administered over 60 minutes at week 4

Group Type: EXPERIMENTAL

131I-Sibrotuzumab

Intervention Type: DRUG

50 mg Sibrotuzumab conjugated with 131I

Interventions

131I-Sibrotuzumab

50 mg Sibrotuzumab conjugated with 131I

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1152.6

Identifier Type: -

Identifier Source: org_study_id