A Study of Dulanermin Administered in Combination With Camptosar®/Erbitux® Chemotherapy or FOLFIRI (With or Without Bevacizumab) in Subjects With Previously Treated Metastatic Colorectal Cancer
NCT ID: NCT00671372
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
42 participants
INTERVENTIONAL
2006-07-31
2012-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohorts 1-5
cetuximab
Intravenous repeating dose
dulanermin
Intravenous repeating dose
irinotecan
Intravenous repeating dose
Cohorts 6, 6A, 7, 7A
FOLFIRI regimen
Intravenous repeating dose
bevacizumab
Intravenous repeating dose (for Cohort 6 subjects not previously treated with bevacizumab)
dulanermin
Intravenous repeating dose
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
FOLFIRI regimen
Intravenous repeating dose
bevacizumab
Intravenous repeating dose (for Cohort 6 subjects not previously treated with bevacizumab)
cetuximab
Intravenous repeating dose
dulanermin
Intravenous repeating dose
irinotecan
Intravenous repeating dose
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age \>= 18 years
* Histologically confirmed CRC with evidence of metastases and measurable tumor lesion(s)
* Progression of disease following, or intolerance to, treatment with 5-fluorouracil-based therapy
* Progression of disease during or within =\< 6 months following the last dose of a prior first-line treatment with a fluoropyrimidine and oxaliplatin-based chemotherapy plus bevacizumab for metastatic disease
* Use of an effective means of contraception for women of childbearing potential and men with partners of childbearing potential (use per institutional standard)
* Life expectancy of \> 3 months
* Willingness and capability to be accessible for study follow-up
Exclusion Criteria
* Radiation therapy to a peripheral lesion within 14 days prior to Day 1; Radiation therapy to a thoracic, abdominal or pelvic field within 28 days prior to Day 1
* Chemotherapy, hormonal therapy, or immunology within 4 weeks prior to Day 1
* Previous exposure to DR4-targeted therapy or DR5-targeted therapy
* Evidence of clinically detectable ascites on Day
* Other invasive malignancies within 5 years prior to Day 1 (other than basal cell carcinoma of the skin or in situ carcinoma of the cervix)
* History or evidence upon physical examination of CNS disease
* Active infection requiring parenteral antibiotics on Day 1
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 or anticipation of need for major surgical procedure during the course of the study and fine needle aspirations within 7 days prior to Day 1
* Pregnancy or lactation
* Serious nonhealing wound, ulcer, or bone fracture
* Current or recent participation in another experimental drug study
* Clinically significant cardiovascular disease
* History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk from treatment complications
* Cohort 5 only: Subjects who have a Kras mutation will be excluded from enrollment
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Genentech, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Chia Portera, M.D.
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Los Angeles, California, United States
Redlands, California, United States
San Francisco, California, United States
Fort Myers, Florida, United States
Harvey, Illinois, United States
Buffalo, New York, United States
Durham, North Carolina, United States
Hershey, Pennsylvania, United States
Nashville, Tennessee, United States
Tacoma, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GO00933
Identifier Type: -
Identifier Source: secondary_id
APO3583g
Identifier Type: -
Identifier Source: org_study_id