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A Study of PRO95780 Administered in Combination With the FOLFOX Regimen and Bevacizumab in Patients With Previously Untreated, Locally Advanced, Recurrent, and Metastatic Colorectal Cancer (APM4566g)

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.
 
ClinicalTrials.gov Identifier: NCT00851136
Recruitment Status : Completed
First Posted : February 25, 2009
Last Update Posted : July 1, 2010
Sponsor:
Information provided by:
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE February 23, 2009
First Posted Date  ICMJE February 25, 2009
Last Update Posted Date July 1, 2010
Study Start Date  ICMJE May 2009
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2009)
Incidence and nature of dose-limiting toxicities [ Time Frame: Length and study ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00851136 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2009)
  • Incidence, nature, and severity of adverse events [ Time Frame: Length of study ]
  • Change in vital signs [ Time Frame: Length of study ]
  • Incidence and severity of infusion reactions [ Time Frame: Length of study ]
  • Change in clinical laboratory results [ Time Frame: Length of study ]
  • Incidence of anti-PRO95780 antibodies [ Time Frame: Length of study ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2009)
  • Incidence, nature, and severity of adverse events [ Time Frame: Length of study ]
  • Change in vital signs [ Time Frame: Length of study ]
  • Incidence and severity of infusion reactions [ Time Frame: Length of study ]
  • Change in clinical laboratory results [ Time Frame: Length of study ]
  • Incidence of anti-Apomab antibodies [ Time Frame: Length of study ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of PRO95780 Administered in Combination With the FOLFOX Regimen and Bevacizumab in Patients With Previously Untreated, Locally Advanced, Recurrent, and Metastatic Colorectal Cancer (APM4566g)
Official Title  ICMJE A Phase Ib Study of the Safety and Pharmacokinetics of PRO95780 Administered in Combination With the FOLFOX Regimen and Bevacizumab in Patients With Previously Untreated, Locally Advanced, Recurrent, and Metastatic Colorectal Cancer
Brief Summary This will be a multicenter, open-label study enrolling a total of up to 23 patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Colorectal Cancer
Intervention  ICMJE
  • Drug: bevacizumab
    Intravenous repeating dose
  • Drug: FOLFOX
    Intravenous repeating dose
  • Drug: PRO95780
    Intravenous repeating dose
Study Arms  ICMJE Experimental: 1
Interventions:
  • Drug: bevacizumab
  • Drug: FOLFOX
  • Drug: PRO95780
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 29, 2010)
9
Original Estimated Enrollment  ICMJE
 (submitted: February 23, 2009)
23
Actual Study Completion Date  ICMJE June 2010
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed CRC with evidence of locally advanced recurrent or metastatic disease 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 and for 6 months following their final exposure to study treatment
  • 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
  • History or evidence upon physical examination of active central nervous system (CNS) disease
  • 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
  • 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 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
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00851136
Other Study ID Numbers  ICMJE APM4566g
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Clinical Trials Posting Group, Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Chia Portera, M.D. Genentech, Inc.
PRS Account Genentech, Inc.
Verification Date June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP