- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00056537
ABR-217620 in Patients With Advanced Non-Small Cell Lung Cancer, Renal Clear Cell Carcinoma or Pancreatic Cancer
August 26, 2014 updated by: Active Biotech AB
An Open-Label, Phase I, Repeat Dose-Escalation Study of ABR-217620 in Patients With Advanced Non-Small Cell Lung Cancer, Renal Clear Cell Carcinoma or Pancreatic Cancer
The drug ABR-217620 is a combination of two proteins, one that recognizes tumor cells and one that triggers an attack on the tumor cells by activating some white blood cells belonging to the body's normal immune system.
In animals, this results in an accumulation of white blood cells in the cancer that can fight the cancer.
This study will test how much of the drug can be given to patients with non-small cell lung cancer, renal clear cell carcinoma, or pancreatic cancer without causing unacceptable side effects.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Oslo, Norway
- Det Norske Radiumhospitalet
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Manchester, United Kingdom, M20 4BX
- Paterson Institute for Cancer Research, Christie Hospital NHS Trust and Research Institute
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19111
- Fox Chase Cancer Center
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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:
- Patients with histologically or cytologically confirmed non-small cell lung cancer, which is refractory to (progressed on or following) currently available standard therapies. Patients must have received (or declined) at least one standard regimen for advanced/metastatic disease.
- ECOG performance status of 0 or 1.
- Adequate bone marrow function as defined by absolute neutrophil count greater than or equal to 1500/mm3, and platelets greater than or equal to 100,000/mm3, and hemoglobin greater than or equal to 10 g/dL.
- Adequate renal function: creatinine less than or equal to 1.5 x upper limit of normal.
- Adequate hepatic function: bilirubin less than or equal to 2 x upper limit of normal, and SGOT (S-ASAT) and SGPT (S-ALAT) less than or equal to 2.5 x upper limit of normal.
- Life expectancy greater than 3 months.
Exclusion Criteria:
- Pregnant or breast-feeding women, or women of childbearing potential unless effective methods of contraception are used.
- A serious uncontrolled medical disorder or active infection that would impair the patient's ability to receive study treatment.
- History of or any concurrent malignancy, with the exception of the following malignancies, which may still be included: non-melanoma skin cancer, cervical cancer in situ, DCIS or LCIS of breast, past history of resected melanoma without clinical evidence of recurrent melanoma, past history of prostate cancer without clinical evidence of disease (includes patients receiving hormonal therapy).
- History of brain metastases, unless stable for more than 4 weeks, and not requiring steroid therapy and without clinical symptoms of brain metastases.
- Acute illness or evidence of infection, including unexplained fever (temperature greater than 100.5 degrees Fahrenheit or 38.1 degrees Celsius).
- Significant symptomatic cardiac disease including: history (within the past 6 months) or current unstable angina, congestive heart failure, or myocardial infarction; or patients with uncontrolled hypertension, or hypertension that is controlled only with multiply drugs (control by monotherapy is permitted).
- History of or current arrhythmias requiring treatment, with the exception of non-specific, asymptomatic ST-T wave changes or extrasystoles.
- History of cerebrovascular accident within the past 5 years.
- Seizure disorder requiring therapy.
- Treatment with beta-blockers, including topical therapy for glaucoma, during the 6-day treatment period (5 days' treatment + 1 day in patient follow-up), and within five days prior to start of treatment.
- Simultaneous participation in any other study involving investigational drugs or having participated in a study less than 4 weeks prior to start of study treatment.
- Treatment with systemic or inhaled corticosteroids within 2 weeks prior to the start of treatment.
- Treatment with anticoagulants, except when used to maintain the patency of a central venous line.
- Active autoimmune disease requiring therapy or any history of systemic lupus erythematosus or rheumatoid arthritis.
- Chemo/radio/immunotherapy less than 4 weeks (6 weeks for mitomycin C and nitrosoureas) before start of treatment.
- Major surgery less than 3 weeks.
- Known positive serology for HIV (patients with a known history of HIV will be excluded because of potential for unforeseen toxicity and morbidity in the immunocompromised host).
- Known chronic Hepatitis B or C.
- Previous exposure to murine monoclonal antibody (with HAMA titer above detection limit at baseline) or known hypersensitivity to murine proteins.
- Patients currently on renal dialysis treatment.
- Known allergy or hypersensitivity to aminoglycosides e.g. kanamycin.
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 |
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Experimental: 1
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Starting dose: 0.5 mcg/kg; subsequent doses: individual, based on pre-treatment level of anti-SEA/E-120, body weight, and toxicities observed in prior patients on study; IV; one bolus injection each day for 5 consecutive days; up to 3 cycles
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Maximum Tolerated Dose (MTD) as a function of pre-treatment anti-SEA/E-120 levels
Time Frame: 56 days after start of first treatment cycle
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56 days after start of first treatment cycle
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Safety profile
Time Frame: During or after first treatment cycle, second treatment cycle, later cycles if available
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During or after first treatment cycle, second treatment cycle, later cycles if available
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Pharmacokinetic parameters
Time Frame: Days 1 and 5 of each cycle
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Days 1 and 5 of each cycle
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Immunological response
Time Frame: Days 28 and 56 of first and second treatment cycles, later cycles if available
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Days 28 and 56 of first and second treatment cycles, later cycles if available
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Objective response rate
Time Frame: Days 28 and 56 of first and second treatment cycles, later cycles if available
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Days 28 and 56 of first and second treatment cycles, later cycles if available
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Time to progression and Survival
Time Frame: Followed for up to 2 years
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Followed for up to 2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Suzanne Kilany, Active Biotech AB
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
April 1, 2003
Primary Completion (Actual)
December 1, 2006
Study Completion (Actual)
December 1, 2006
Study Registration Dates
First Submitted
March 16, 2003
First Submitted That Met QC Criteria
March 17, 2003
First Posted (Estimate)
March 18, 2003
Study Record Updates
Last Update Posted (Estimate)
August 27, 2014
Last Update Submitted That Met QC Criteria
August 26, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Neoplasms, Complex and Mixed
- Pancreatic Diseases
- Kidney Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Carcinoma
- Pancreatic Neoplasms
- Adenocarcinoma, Clear Cell
- Adenomyoepithelioma
Other Study ID Numbers
- 01762001
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.
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