- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00873756
A Study of Dulanermin Administered in Combination With the FOLFOX Regimen and Bevacizumab in Patients With Previously Untreated, Locally Advanced, Recurrent, or Metastatic Colorectal Cancer
November 1, 2016 updated by: Genentech, Inc.
A Phase Ib Study of the Safety and Pharmacokinetics of Dulanermin Administered in Combination With the FOLFOX Regimen and Bevacizumab in Patients With Previously Untreated, Locally Advanced, Recurrent, or Metastatic Colorectal Cancer
This is a multicenter, open-label study enrolling a total of up to 23 patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
23
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
-
-
California
-
Los Angeles, California, United States, 90095
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San Francisco, California, United States, 94115
-
-
Colorado
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Aurora, Colorado, United States, 80045
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Fort Collins, Colorado, United States, 80528
-
-
Illinois
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Harvey, Illinois, United States, 60426
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New Mexico
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Albuquerque, New Mexico, United States, 87131
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North Carolina
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Chapel HIll, North Carolina, United States, 27599
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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:
- Histologically confirmed CRC with evidence of locally advanced recurrent or metastatic disease (i.e., by radiographic imaging or biopsy) and measurable tumor lesions
- Life expectancy > 3 months
- For patients of reproductive potential (males and females), use of reliable means for contraception throughout the trial
- Willingness and capability to be accessible for study follow-up
Exclusion Criteria:
- Prior 5-FU, capecitabine, and/or oxaliplatin treatment with the exception of: prior oxaliplatin treatment =< 6 weeks in the advanced or metastatic setting; prior treatment with 5-FU, capecitabine, and/or oxaliplatin in the adjuvant setting if relapse occurred > 6 months from concluding adjuvant therapy
- Peripheral neuropathy Grade >= 2
- Prior radiotherapy to a measurable metastatic lesion(s) to be used for response assessment, unless the lesion has progressed subsequent to the radiotherapy
- Radiotherapy to a peripheral lesion within 14 days prior to Cycle 1, Day 1, or radiotherapy to a thoracic, abdominal, or pelvic field within 28 days prior to Cycle 1, Day 1
- Chemotherapy, hormonal therapy, or immunotherapy within 4 weeks prior to Cycle 1, Day 1
- Evidence of clinically detectable ascites
- Other invasive malignancies within 5 years prior to Cycle 1, Day 1
- Current or recent participation in another experimental drug study
- Clinically significant cardiovascular disease, New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac arrhythmia within 1 year prior to Cycle 1, Day 1, or Grade II or greater peripheral vascular disease on Cycle 1, Day 1
- Active infection requiring parenteral antibiotics
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Cycle 1, Day 1, fine needle aspirations or minor surgery (such as port placement) within 7 days prior to Cycle 1, Day 1, or anticipation of need for major surgical procedure during the course of the study
- Known or suspected to be positive for the human immunodeficiency virus (HIV)
- Known to be positive for hepatitis C or hepatitis B surface antigen
- 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 specified study treatment, or that might affect interpretation of the results of the study or render the patient at high risk from treatment complications
- Inadequately controlled hypertension
- Prior history of hypertensive crisis or hypertensive encephalopathy
- History of arterial thromboembolic event 6 months prior to Cycle 1, Day 1
- History of abdominal fistula or gastrointestinal perforation within 6 months prior to Cycle 1, Day 1
- Bleeding diathesis or coagulopathy
- Pregnancy (positive pregnancy test) or breast feeding
- Serious, non-healing wound, ulcer, or bone fracture
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: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
|
Intravenous repeating dose
Intravenous repeating dose
Intravenous repeating dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence and nature of dose-limiting toxicities
Time Frame: Until study discontinuation or the end of Cycle 26
|
Until study discontinuation or the end of Cycle 26
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence, nature, and severity of adverse events
Time Frame: Until study discontinuation or the end of Cycle 26
|
Until study discontinuation or the end of Cycle 26
|
Change in vital signs
Time Frame: Until study discontinuation or the end of Cycle 26
|
Until study discontinuation or the end of Cycle 26
|
Change in clinical laboratory results
Time Frame: Until study discontinuation or the end of Cycle 26
|
Until study discontinuation or the end of Cycle 26
|
Incidence of anti-dulanermin antibodies
Time Frame: Until study discontinuation or the end of Cycle 26
|
Until study discontinuation or the end of Cycle 26
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
May 1, 2009
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
March 5, 2009
First Submitted That Met QC Criteria
March 31, 2009
First Posted (Estimate)
April 2, 2009
Study Record Updates
Last Update Posted (Estimate)
November 2, 2016
Last Update Submitted That Met QC Criteria
November 1, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Bevacizumab
Other Study ID Numbers
- APO4565g
- GO00934 (Other Identifier: Hoffmann-La Roche)
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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