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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00671372
First received: April 18, 2008
Last updated: November 4, 2014
Last verified: November 2014
  Purpose

This study will assess the safety and pharmacokinetics of adding dulanermin to C amptosar®/Erbitux® or the FOLFIRI regimen (Camptosar®, 5-FU, and leucovorin) plu s bevacizumab (only for Cohort 6 subjects who have not received prior bevacizuma b therapy).


Condition Intervention Phase
Colorectal Cancer
Drug: FOLFIRI regimen
Drug: bevacizumab
Drug: cetuximab
Drug: dulanermin
Drug: irinotecan
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • The safety and tolerability of dulanermin administered in combination with Camptosar and Erbitux [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • The safety and tolerability of dulanermin administered in combination with FOLFIRI (with or without Bevacizumab) [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: July 2006
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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
  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: NCT00671372

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

No publications provided

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00671372     History of Changes
Other Study ID Numbers: APO3583g, GO00933
Study First Received: April 18, 2008
Last Updated: November 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech, Inc.:
CRC
Metastatic CRC
APO2L/TRAIL

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014