- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00132379
ABR-217620 in Combination With Docetaxel in Patients With Advanced Non-small Cell Lung Cancer
August 26, 2014 updated by: Active Biotech AB
An Open-label, Phase I, Dose-escalation Study of ABR-217620 in Combination With Docetaxel in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
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, in combination with docetaxel (an approved drug for treating non-small cell lung cancer [NSCLC]), can be given to patients with NSCLC without causing unacceptable side effects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
13
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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Copenhagen, Denmark
- Onkologisk Klinik, Rigshospitalet
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St. Petersburg, Russian Federation, 194354
- City Multifield Hospital #2, City Center of Intensive Pulmonology and Thoracic Surgery
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St. Petersburg, Russian Federation, 197022
- St. Petersburg Pavlov State Medical University
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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 advanced NSCLC who have progressed on first line platin-based therapy or have failed on other treatment regimens or declined standard regimen.
- ECOG performance status 0 or 1.
- Adequate bone marrow function: absolute neutrophil count greater than or equal to 1500/mm3; WBC greater than or equal to 3000/mm3; 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 (ULN).
- Adequate hepatic function: bilirubin less than ULN; and SGOT (AST) and SGPT (ALT) to less than 1.5 x ULN concomitant with alkaline phosphatase (ALP) less than 2.5 ULN.
Exclusion Criteria:
- Female patients who are pregnant or nursing or planning to become pregnant during the study. Fertile, sexually active women not willing to practice reliable contraception. Male patients with partners of childbearing potential not using acceptable contraceptive method.
- A serious uncontrolled medical disorder or active infection including unexplained fever (temperature greater than 100.5 degrees Fahrenheit or 38.1 degrees Celsius) that would impair the patient's ability to receive study treatment.
- Any concurrent malignancy, except for the following malignancies that may be included: non-melanoma skin cancer; cervical cancer in situ; ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) of breast; or 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.
- Significant symptomatic cardiac disease including history (within past 6 months) or current unstable angina, congestive heart failure, or myocardial infarction; or patients with uncontrolled hypertension, or hypertension requiring treatment with more than 2 drugs.
- History of or current arrhythmias requiring treatment, except for non-specific, asymptomatic ST-T wave changes or extrasystoles.
- Seizure disorder requiring therapy.
- Treatment with beta-blockers, including topical therapy for glaucoma, during the 6-day treatment period (5-day treatment + 1 day in-patient follow-up), and within 5 days before start of ABR-217620 treatment.
- Simultaneous participation in any other investigational drug study or participation in a study less than 4 weeks before start of study treatment.
- Treatment with systemic or inhaled corticosteroids within 2 weeks before 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.
- Concurrent biological response modifiers (within 3 weeks of study entry) except for any type of erythropoetin.
- Chemo/radio/immunotherapy less than 4 weeks (6 weeks for mitomycin C and nitrosoureas) before start of treatment.
- Known allergy or hypersensitivity reactions to aminoglycosides (e.g., kanamycin).
- Known allergy or hypersensitivity reactions to docetaxel or other drugs formulated with polysorbate 80.
- Previous exposure to murine monoclonal antibody (with human anti-mouse antibody [HAMA] titer above detection limit at baseline) or known hypersensitivity to murine proteins.
- Major surgery within 3 weeks.
- Known history of HIV infection.
- Known chronic hepatitis B or C.
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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10.3, 16.5 or 22 mcg/kg, IV, daily 5 minute bolus injection for 4 consecutive day per cycle; up to 6 cycles
Other Names:
75mg/m^2, IV, single 60 minute infusion, beginning on Day 5 then every third week
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Side effect profile (based on blood pressure, body temperature, and laboratory tests)
Time Frame: Day 56 (Day 115 if undergo cycles 3/4)
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Day 56 (Day 115 if undergo cycles 3/4)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Pharmacokinetic parameters
Time Frame: Days 1 and 4 of cycles 1 and 2
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Days 1 and 4 of cycles 1 and 2
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Immunological response
Time Frame: Day 56 (Day 115 if undergo cycles 3/4)
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Day 56 (Day 115 if undergo cycles 3/4)
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Changes in anti-SEA/E-120 levels
Time Frame: Day 56 (Day 115 if undergo cycles 3/4)
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Day 56 (Day 115 if undergo cycles 3/4)
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Objective response rate
Time Frame: Day 56 (Day 115 if undergo cycles 3/4)
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Day 56 (Day 115 if undergo cycles 3/4)
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Time to progression and Survival
Time Frame: Followed for up to 1 year
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Followed for up to 1 year
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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
November 1, 2005
Primary Completion (Actual)
December 1, 2006
Study Completion (Actual)
December 1, 2006
Study Registration Dates
First Submitted
August 19, 2005
First Submitted That Met QC Criteria
August 19, 2005
First Posted (Estimate)
August 22, 2005
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
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Docetaxel
Other Study ID Numbers
- 05762003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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