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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00671372
Recruitment Status : Completed
First Posted : May 5, 2008
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Genentech, Inc.

Brief Summary:
This study will assess the safety and pharmacokinetics of adding dulanermin to Camptosar®/Erbitux® or the FOLFIRI regimen (Camptosar®, 5-FU, and leucovorin) plus bevacizumab (only for Cohort 6 subjects who have not received prior bevacizumab therapy).

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: FOLFIRI regimen Drug: bevacizumab Drug: cetuximab Drug: dulanermin Drug: irinotecan Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Multiple Doses of Dulanermin Administered Intravenously in Combination With Camptosar®/Erbitux® Chemotherapy or the Folfiri Regimen With or Without Bevacizumab in Subjects With Previously Treated Metastatic Colorectal Cancer
Study Start Date : July 2006
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Cohorts 1-5 Drug: cetuximab
Intravenous repeating dose

Drug: dulanermin
Intravenous repeating dose

Drug: irinotecan
Intravenous repeating dose

Experimental: Cohorts 6, 6A, 7, 7A Drug: FOLFIRI regimen
Intravenous repeating dose

Drug: bevacizumab
Intravenous repeating dose (for Cohort 6 subjects not previously treated with bevacizumab)

Drug: dulanermin
Intravenous repeating dose

Primary Outcome Measures :
  1. The safety and tolerability of dulanermin administered in combination with Camptosar and Erbitux [ Time Frame: Length of study ]
  2. The safety and tolerability of dulanermin administered in combination with FOLFIRI (with or without Bevacizumab) [ Time Frame: Length of study ]

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

Inclusion Criteria:

  • Signed Informed Consent Form
  • 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:

  • Prior radiotherapy to a measurable, metastatic lesion(s) to be used to measure response
  • 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
  • The following exclusion criteria apply only to subjects who have received prior bevacizumab and are enrolled in Cohort 6: four or more prior doses of bevacizumab therapy, inadequately controlled hypertension, history of hypertensive crisis or hypertensive encephalopathy, history of arterial thromboembolic event 6 months prior to Day 1, proteinuria, history of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00671372

United States, California
Los Angeles, California, United States, 90095
Redlands, California, United States, 92374
San Francisco, California, United States, 94115
United States, Florida
Fort Myers, Florida, United States, 33916
United States, Illinois
Harvey, Illinois, United States, 60426
United States, New York
Buffalo, New York, United States, 14263
United States, North Carolina
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Hershey, Pennsylvania, United States, 17033
United States, Tennessee
Nashville, Tennessee, United States, 37203
United States, Washington
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Genentech, Inc.
Study Director: Chia Portera, M.D. Genentech, Inc.

Responsible Party: Genentech, Inc. Identifier: NCT00671372     History of Changes
Other Study ID Numbers: APO3583g
First Posted: May 5, 2008    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Keywords provided by Genentech, Inc.:
Metastatic CRC

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
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action