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.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00873756
First received: March 5, 2009
Last updated: September 2, 2014
Last verified: September 2014
  Purpose

This is a multicenter, open-label study enrolling a total of up to 23 patients.


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

Primary Outcome Measures:
  • Incidence and nature of dose-limiting toxicities [ Time Frame: Until study discontinuation or the end of Cycle 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence, nature, and severity of adverse events [ Time Frame: Until study discontinuation or the end of Cycle 26 ] [ Designated as safety issue: No ]
  • Change in vital signs [ Time Frame: Until study discontinuation or the end of Cycle 26 ] [ Designated as safety issue: No ]
  • Change in clinical laboratory results [ Time Frame: Until study discontinuation or the end of Cycle 26 ] [ Designated as safety issue: No ]
  • Incidence of anti-dulanermin antibodies [ Time Frame: Until study discontinuation or the end of Cycle 26 ] [ Designated as safety issue: No ]

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: bevacizumab
Intravenous repeating dose
Drug: dulanermin
Intravenous repeating dose
Drug: FOLFOX regimen
Intravenous repeating dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00873756

Locations
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
Investigators
Study Director: Chia Portera, M.D. Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT00873756     History of Changes
Other Study ID Numbers: APO4565g, GO00934
Study First Received: March 5, 2009
Last Updated: September 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
CRC
Colon Cancer
Avastin
Apo2L/TRAIL

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Oxaliplatin
Fluorouracil
Leucovorin
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Vitamin B Complex
Vitamins
Micronutrients
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents

ClinicalTrials.gov processed this record on September 22, 2014