A Study Evaluating the Efficacy and Safety of MEGF0444A Dosed to Progression in Combination With Bevacizumab and Folfox in Patients With Previously Untreated Metastatic Colorectal Cancer (CONGO)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01399684
First received: July 20, 2011
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

This is a Phase II, multicenter, randomized, double-blind, placebo-controlled trial designed to estimate the efficacy of MEGF0444A treatment to disease progression, combined with mFOLFOX-6 + bevacizumab therapy in patients with metastatic colorectal cancer (mCRC).


Condition Intervention Phase
Metastatic Colorectal Cancer
Drug: bevacizumab
Drug: MEGF0444A
Drug: mFOLFOX6
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of MEGF0444A Dosed to Progression in Combination With Bevacizumab and Folfox in Patients With Previously Untreated Metastatic Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Progression-free survival (defined as the time from randomization to the first occurrence of progression based on RECIST v1.1 criteria or death from any cause on study) [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response (OR) (partial response plus complete response) as determined by the investigator using RECIST v1.1 [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
  • Duration of overall response (OR) (defined as the first occurrence of a documented objective response until the time of progression or death from any cause on study) [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
  • Overall survival (OS) (defined as the time from randomization until death from any cause) [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]

Enrollment: 128
Study Start Date: November 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: bevacizumab
Intravenous repeating dose
Drug: mFOLFOX6
Intravenous repeating dose
Drug: placebo
Intravenous repeating dose
Experimental: B Drug: bevacizumab
Intravenous repeating dose
Drug: MEGF0444A
Intravenous repeating dose
Drug: mFOLFOX6
Intravenous repeating dose

  Eligibility

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

Inclusion Criteria:

  • ECOG performance status of 0 or 1
  • Adequate hematologic and end organ function
  • For female patients of childbearing potential and male patients with partners of childbearing potential, agreement to use a highly effective form of contraception and to continue its use for 6 months after the last dose of bevacizumab or MEGF0444A/placebo
  • Negative serum pregnancy test within 7 days prior to starting study treatment in premenopausal women and women < 2 years after the onset of menopause

Exclusion Criteria:

  • Any prior systemic therapy (including chemotherapy, antibody therapy, tyrosine kinase inhibitors, radiotherapy, immunotherapy, hormonal therapy or investigational therapy) before Day 1 of Cycle 1 for treatment of mCRC
  • Malignancies other than CRC within 5 years prior to randomization, except for those with a negligible risk of metastasis or death
  • Radiotherapy to any site for any reason within 28 days prior to Day 1 of Cycle 1
  • Clinically detectable third-space fluid collections that cannot be controlled by drainage or other procedures prior to study entry
  • Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to Day 1 of Cycle 1
  • Lactating women
  • Clinically suspected or confirmed CNS metastases or carcinomatous meningitis
  • Active infection requiring IV antibiotics
  • Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs, inhaled corticosteroids, or the equivalent of ⿤ 10 mg/day prednisone
  • Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, or cirrhosis
  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: NCT01399684

  Show 40 Study Locations
Sponsors and Collaborators
Genentech
Investigators
Study Director: Ina Rhee, M.D., Ph.D. Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01399684     History of Changes
Other Study ID Numbers: MEF4982g, GO27812
Study First Received: July 20, 2011
Last Updated: March 4, 2014
Health Authority: United States: Food and Drug Administration

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
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2014