A Study of Carboplatin and Pemetrexed Plus Demcizumab (OMP-21M18) in Subjects With Non-Squamous Non-Small Cell Lung Cancer
- Registration Number
- NCT01189968
- Lead Sponsor
- OncoMed Pharmaceuticals, Inc.
- Brief Summary
The purpose of this study is to test the safety and determine the optimal dose of a new drug, demcizumab (OMP-21M18), when given in combination with carboplatin and pemetrexed, a standard drug treatment regimen for non-squamous non-small cell lung cancer (NSCLC). Participants must not have received prior chemotherapy for their NSCLC. Demcizumab is a humanized monoclonal antibody (a protein made in the laboratory) developed to target cancer stem cells. The way the body handles demcizumab will also be investigated.
Up to 50 subjects will be enrolled at up to 8 centers in Australia, New Zealand, and Spain. Up to 28 days (4 weeks) prior to treatment you will undergo testing to determine your eligibility to take part in this study, and then if enrolled in the study you will receive intravenous (in the vein) infusions of the demcizumab, carboplatin, and pemetrexed administered on the same day, every 21 days for 4 cycles, or until it has been shown that your cancer has progressed. If your physician decides to delay treatment with one of the agents due to side effects, the other agents may still be administered as scheduled. After 4 cycles, if you have stable or improved disease, you will continue to receive pemetrexed once every 21 days as maintenance therapy. You will undergo assessments every 8 weeks to determine the status of your disease.
- Detailed Description
Current cancer therapies often produce an initial reduction in tumour size but may not have longterm benefits. One possible explanation for this is the presence of cancer cells known as cancer stem cells. Cancer stem cells represent a small part of the tumour but are believed to be responsible for much of the growth and spread of the cancer. They may also be more resistant to traditional therapy, such as chemotherapy and radiation therapy.
Up to 50 subjects will be enrolled at up to 8 centers in Australia, New Zealand, and Spain. Up to 28 days (4 weeks) prior to treatment you will undergo testing to determine your eligibility to take part in this study, and then if enrolled in the study you will receive intravenous (in the vein) infusions of the demcizumab, carboplatin, and pemetrexed administered on the same day, every 21 days for 4 cycles, or until it has been shown that your cancer has progressed. If your physician decides to delay treatment with one of the agents due to side effects, the other agents may still be administered as scheduled. After 4 cycles, if you have stable or improved disease, you will continue to receive pemetrexed once every 21 days as maintenance therapy. You will undergo assessments every 8 weeks to determine the status of your disease.
In addition to routine testing of blood and urine (for complete blood counts with differential and platelets, coagulation studies to determine how quickly your blood is clotting; serum chemistries; B-type natriuretic peptide \[BNP\] and Troponin I, which indicate how well your heart if working; creatinine clearance to measure your kidney function and urinalysis), special tests will be performed during the study at specific time points.
In addition, you will have an ECG and doppler echocardiogram performed during screening, then every 28 days on study and at treatment termination. Your Doppler echocardiograms may be sent to a Cardiologist at another hospital who may perform a central read on some of the doppler echocardiograms in this study. Finally, you will have a head CT or MRI at baseline and CT scans and/or other radiographs performed every 56 days to assess the status of your tumor.
The study includes an optional part which will investigate how variations in people's genetic makeup affect their response to medications. This involves the collection of one blood sample just before participants receive their first dose of study treatment. DNA will be extracted from the blood sample for testing.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Carboplatin and Pemetrexed plus demcizumab Demcizumab Carboplatin and Pemetrexed plus demcizumab Pemetrexed plus demcizumab Demcizumab Pemetrexed plus demcizumab
- Primary Outcome Measures
Name Time Method To the determine the maximum tolerated dose of demcizumab (OMP-21M18) plus carboplatin and pemetrexed When each patient in the dose cohort reaches Day 56
- Secondary Outcome Measures
Name Time Method To determine the safety of carboplatin and pemetrexed plus demcizumab (OMP-21M18) until treatment termination plus 30 days To determine the rates of immunogenicity of carboplatin and pemetrexed plus demcizumab (OMP-21M18) Up to 12 weeks post treatment termination To determine the preliminary efficacy of carboplatin and pemetrexed plus demcizumab (OMP-21M18) Until disease progression To determine population pharmacokinetics Day 21 and 63 To determine the exploratory biomarker changes of carboplatin and pemetrexed plus demcizumab (OMP-21M18) Until Day 112
Trial Locations
- Locations (7)
START Madrid
🇪🇸Madrid, Spain
Sir Charles Gairdner Hospital
🇦🇺Nedlands, Western Australia, Australia
Monash Medical Centre
🇦🇺Clayton, Victoria, Australia
Auckland Hospital
🇳🇿Grafton, Auckland, New Zealand
Royal Brisbane & Women's Hospital
🇦🇺Herston, Queensland, Australia
Waikato Hospital
🇳🇿Hamilton, New Zealand
Ashford Cancer Centre Research
🇦🇺Kurralta Park, South Australia, Australia