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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

This study has been completed.
Information provided by (Responsible Party):
Genentech, Inc. Identifier:
First received: March 5, 2009
Last updated: November 1, 2016
Last verified: November 2016
This is a multicenter, open-label study enrolling a total of up to 23 patients.

Condition Intervention Phase
Metastatic Colorectal Cancer
Drug: FOLFOX regimen
Drug: bevacizumab
Drug: dulanermin
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Incidence and nature of dose-limiting toxicities [ Time Frame: Until study discontinuation or the end of Cycle 26 ]

Secondary Outcome Measures:
  • Incidence, nature, and severity of adverse events [ Time Frame: Until study discontinuation or the end of Cycle 26 ]
  • Change in vital signs [ Time Frame: 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 ]
  • Incidence of anti-dulanermin antibodies [ Time Frame: Until study discontinuation or the end of Cycle 26 ]

Enrollment: 23
Study Start Date: May 2009
Study Completion Date: April 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: FOLFOX regimen
Intravenous repeating dose
Drug: bevacizumab
Intravenous repeating dose
Drug: dulanermin
Intravenous repeating dose


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00873756

United States, California
Los Angeles, California, United States, 90095
San Francisco, California, United States, 94115
United States, Colorado
Aurora, Colorado, United States, 80045
Fort Collins, Colorado, United States, 80528
United States, Illinois
Harvey, Illinois, United States, 60426
United States, New Mexico
Albuquerque, New Mexico, United States, 87131
United States, North Carolina
Chapel HIll, North Carolina, United States, 27599
Sponsors and Collaborators
Genentech, Inc.
Study Director: Chia Portera, M.D. Genentech, Inc.
  More Information

Responsible Party: Genentech, Inc. Identifier: NCT00873756     History of Changes
Other Study ID Numbers: APO4565g
GO00934 ( Other Identifier: Hoffmann-La Roche )
Study First Received: March 5, 2009
Last Updated: November 1, 2016

Keywords provided by Genentech, Inc.:
Colon Cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Protective Agents
Vitamin B Complex
Vitamins processed this record on May 25, 2017