A Study of FOLFIRI Plus OMP-21M18 as 1st or 2nd-line Treatment in Subjects With Metastatic Colorectal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01189942|
Recruitment Status : Completed
First Posted : August 27, 2010
Last Update Posted : September 20, 2016
The purpose of this study is to test the safety and determine the optimal dose of a new drug, OMP-21M18, when given in combination with FOLFIRI, a standard drug treatment for advanced colorectal cancer. Participants must not have had more than one chemotherapy regimen for their metastatic disease. OMP-21M18 is a humanized monoclonal antibody (a protein made in the laboratory) developed to target cancer stem cells. The way the body handles OMP-21M18 will also be investigated.
Up to 32 participants, 21 years or older, at up to 6 centres in Australia and New Zealand, will receive intravenous infusions of OMP-21M18 followed by FOLFIRI every two weeks, until disease progression or limited by drug toxicity. After 8 weeks, participants will undergo assessments to determine their disease status. If there is no evidence of disease progression participants will continue to receive infusions of OMP-21M18 and FOLFIRI every second week, until disease progression.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: OMP-21M18||Phase 1|
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 cancer cells known as a 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 types of therapy, such as chemotherapy and radiation therapy.
The purpose of this study is to test the safety and determine the optimal dose of a new experimental drug, OMP-21M18, when given in combination with FOLFIRI, a chemotherapy regimen consisting of the following three medications: folinic acid (leucovorin), 5fluorouracil and irinotecan. The administration of these three medications is a standard treatment for advanced colorectal cancer. OMP-21M18 is a humanized monoclonal antibody (a protein made in the laboratory) developed to target cancer stem cells. The way the body handles OMP21M18 will also be investigated.
Up to 32 participants, 21 years or older, will be enrolled at up to 6 centres in Australia and New Zealand. Following informed consent and screening, FOLFIRI will be administered once every 14 days (or until toxicity necessitates reducing or delaying a dose). OMP-21M18 will be administered by intravenous (IV) infusion once every 14 days on the same day as FOLFIRI. A Data Safety Monitoring Board (DSMB) will review the data for the 6 participants in each dose level after the last participant in that group has been treated for 56 days and decide whether it is safe to move up to the next highest dose level. After confirming the optimum dose, 14 additional participants will be treated at the highest dose level that the DSMB considers safe.
Participants will be assessed for disease status every 8 weeks and for safety at every visit and for 30 days after the end of study drug treatment. Safety will be assessed by adverse event monitoring, physical examination, vital signs, blood tests, cardiac monitoring, and participant interview. Response rates, duration of response, time to progression, and survival will be evaluated requiring CT or MRI scans and CEA (tumour marker) levels at baseline and then every 8 weeks. The development of antibodies to treatment will be assessed throughout the study and up to 12 weeks after the end of study drug treatment. During the study blood samples will be taken to assess whether OMP21M18 is producing desired changes to the genes and proteins related to the cancer (biomarkers). 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b Study of FOLFIRI Plus OMP-21M18 as 1st or 2nd-line Treatment in Subjects With Metastatic Colorectal Cancer|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||February 2011|
- Drug: OMP-21M18
The first 6 participants will receive OMP21M18 2.5 mg/kg once every other week, the next 6 participants will receive 5 mg/kg once every other week, and the final 6 participants will receive 10 mg/kg once every other week. A Data Safety Monitoring Board (DSMB) will review the data for the 6 participants in each dose level after the last participant in that group has been treated for 56 days and decide whether it is safe to move up to the next highest dose level. After confirming the optimum dose, 14 additional participants will be treated at the highest dose level that the DSMB considers safe.
- To the determine the maximum tolerated dose of OMP-21M18 plus FOLFIRI [ Time Frame: Will be done after each patient in dose cohort reaches Day 56 ]
- To determine the safety of FOLFIRI plus OMP-21M18 at two dose levels [ Time Frame: Until disease progression plus 30 days after ]
- To determine the rates of immunogenicity of FOLFIRI plus OMP-21M18 [ Time Frame: Up until 12 weeks after patient has Disease Progression ]
- To determine population pharmacokinetics [ Time Frame: Until Disease Progression ]
- To determine the exploratory biomarker changes of FOLFIRI plus OMP 21M18 [ Time Frame: Until Disease Progression ]
- To determine the preliminary efficacy of FOLFIRI plus OMP-21M18 [ Time Frame: Until Disease Progression ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01189942
|Australia, New South Wales|
|Sydney Cancer Centre|
|Camperdown, New South Wales, Australia, 2050|
|Royal Brisbane & Women's Hospital|
|Herston, Queensland, Australia, 4029|
|Australia, South Australia|
|Ashford Cancer Centre Research|
|Kurralta Park, South Australia, Australia, 5037|
|Australia, Western Australia|
|Sir Charles Gairdner Hospital|
|Nedlands, Western Australia, Australia, 6009|
|Hamilton, New Zealand, 3240|