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

NCT02209727 | Terminated Phase 1

• 1 other identifier: 1152.6
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (3)

• Determination of the dose limiting toxicity (DLT)

  up to 12 weeks

• Determination of the maximum tolerated dose (MTD)

  MTD is defined as the highest dose below which two patients experience DLT

  up to 12 weeks

• Occurrence of toxicity

  graded according to the Common Toxicity Criteria (CTC)

  up to 12 weeks

Secondary Outcomes (1)

• Maximum tumor response using the World Health Organisation (WHO) Disease Response Criteria

  8 weeks after therapeutic infusion

Study Arms (1)

131I-Sibrotuzumab

EXPERIMENTAL

single therapy dose administered over 60 minutes at week 4

Drug: 131I-Sibrotuzumab

Interventions

131I-Sibrotuzumab DRUG

50 mg Sibrotuzumab conjugated with 131I

131I-Sibrotuzumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2014
• First Posted: August 6, 2014
• Study Start: December 1, 2000
• Primary Completion: June 1, 2002
• Last Updated: August 6, 2014

Record last verified: 2014-08