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

November 1, 2016 updated by: Genentech, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
      • San Francisco, California, United States, 94115
    • Colorado
      • Aurora, Colorado, United States, 80045
      • Fort Collins, Colorado, United States, 80528
    • Illinois
      • Harvey, Illinois, United States, 60426
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
    • North Carolina
      • Chapel HIll, North Carolina, United States, 27599

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Drug: bevacizumab
Intravenous repeating dose
Drug: FOLFOX regimen
Intravenous repeating dose
Drug: dulanermin
Intravenous repeating dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence and nature of dose-limiting toxicities
Time Frame: Until study discontinuation or the end of Cycle 26
Until study discontinuation or the end of Cycle 26

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence, nature, and severity of adverse events
Time Frame: Until study discontinuation or the end of Cycle 26
Until study discontinuation or the end of Cycle 26
Change in vital signs
Time Frame: Until study discontinuation or the end of Cycle 26
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
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
Until study discontinuation or the end of Cycle 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

March 5, 2009

First Submitted That Met QC Criteria

March 31, 2009

First Posted (Estimate)

April 2, 2009

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APO4565g
  • GO00934 (Other Identifier: Hoffmann-La Roche)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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