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
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
2 other identifiers
interventional
23
1 country
7
Brief Summary
This is a multicenter, open-label study enrolling a total of up to 23 patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2009
Longer than P75 for phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2009
CompletedFirst Posted
Study publicly available on registry
April 2, 2009
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedNovember 2, 2016
November 1, 2016
4.8 years
March 5, 2009
November 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence and nature of dose-limiting toxicities
Until study discontinuation or the end of Cycle 26
Secondary Outcomes (4)
Incidence, nature, and severity of adverse events
Until study discontinuation or the end of Cycle 26
Change in vital signs
Until study discontinuation or the end of Cycle 26
Change in clinical laboratory results
Until study discontinuation or the end of Cycle 26
Incidence of anti-dulanermin antibodies
Until study discontinuation or the end of Cycle 26
Study Arms (1)
A
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (7)
Unknown Facility
Los Angeles, California, 90095, United States
Unknown Facility
San Francisco, California, 94115, United States
Unknown Facility
Aurora, Colorado, 80045, United States
Unknown Facility
Fort Collins, Colorado, 80528, United States
Unknown Facility
Harvey, Illinois, 60426, United States
Unknown Facility
Albuquerque, New Mexico, 87131, United States
Unknown Facility
Chapel Hill, North Carolina, 27599, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Chia Portera, M.D.
Genentech, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2009
First Posted
April 2, 2009
Study Start
May 1, 2009
Primary Completion
March 1, 2014
Study Completion
April 1, 2014
Last Updated
November 2, 2016
Record last verified: 2016-11