Know Cancer

or
forgot password

An Open-Label, Randomized Phase 2 Study of ABT-869 in Combination With mFOLFOX6 (Oxaliplatin, 5-Fluorouracil, and Folinic Acid) Versus Bevacizumab in Combination With mFOLFOX6 as Second-line Treatment of Subjects With Advanced Colorectal Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Advanced Colorectal Cancer, Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum

Thank you

Trial Information

An Open-Label, Randomized Phase 2 Study of ABT-869 in Combination With mFOLFOX6 (Oxaliplatin, 5-Fluorouracil, and Folinic Acid) Versus Bevacizumab in Combination With mFOLFOX6 as Second-line Treatment of Subjects With Advanced Colorectal Cancer


Inclusion Criteria:



Subject must be >/= 18 years of age. Subject (male or female) must be diagnosed with
adenocarcinoma of the colon or rectum. Subject must have metastatic disease or locally
recurrent disease that is not amenable to surgical resection with curative intent.

Subject must have received one prior chemotherapy regimen containing irinotecan or a
fluoropyrimidine for locally recurrent or metastatic colon or rectal cancer.

Subject has experienced progressive disease during or following the previous anti-tumor
treatment.

Subject may have received prior adjuvant treatment for colorectal cancer. Subject has
measurable disease by RECIST criteria (randomized portion only). Eastern Cooperative
Oncology Group (ECOG) Performance Score of 0-1. Subject must have adequate bone marrow,
renal and hepatic function. Subject must have Partial Thromboplastin Time (PTT) < 1.5 x
Upper Limit of Normal (ULN) and International Normalized Ratio (INR) < 1.5.

Exclusion Criteria:

Subject has received more than one prior therapy in the metastatic setting. Lead-in Cohort
only: The subject may have received more than one prior therapy in the metastatic setting.

Subject has received cytotoxic chemotherapy within 21 days prior to Study Day 1.

Subject has received non-cytotoxic, anti-cancer therapy within 21 days or within a period
defined by 5 half lives whichever is shorter, prior to Study Day 1.

Subject has not recovered to less than or equal to Grade 1 clinically significant adverse
effects/toxicities of the previous therapy.

Subject has received prior treatment with a tyrosine kinase inhibitor targeting VEGF or
PDGF.

Subject has received prior treatment with oxaliplatin in the metastatic setting. Lead-in
cohort only: Prior treatment with oxaliplatin will be allowed provided that any neuropathy
as a result of the oxaliplatin treatment has resolved to less than or equal to Grade 1.

Subject has had major surgery within 28 days of Study Day 1. Subject has had radiotherapy
within 14 days of Study Day 1. Subject has a history of hypersensitivity to recombinant
murine monoclonal antibodies, oxaliplatin or other platinum-containing compounds,
fluorouracil, or folinic acid.

Subject has a known intolerance to bevacizumab. Subject has untreated brain or meningeal
metastases. Subject is receiving therapeutic anticoagulation therapy . Subject has a
history of/or currently exhibits clinically significant cancer related events of bleeding.

Subject currently exhibits symptomatic or persistent, uncontrolled hypertension.

Subject has a history of myocardial infarction, stroke, or transient ischemic attack
within six months of Study Day 1.

History of another active cancer within the past 5 years except cervical cancer in situ,
in situ carcinoma of the bladder, squamous cell or basal cell carcinoma of the skin.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

Radiographic evaluation every 2 months, clinial evaluation every 2 weeks

Safety Issue:

No

Principal Investigator

Mark D. McKee, MD

Investigator Role:

Study Director

Investigator Affiliation:

AbbVie

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

M10-300

NCT ID:

NCT00707889

Start Date:

October 2008

Completion Date:

May 2012

Related Keywords:

  • Advanced Colorectal Cancer
  • Adenocarcinoma of the Colon
  • Adenocarcinoma of the Rectum
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Colorectal Neoplasms
  • Rectal Neoplasms
  • Colonic Neoplasms

Name

Location

Site Reference ID/Investigator# 11341Chapel Hill, North Carolina  27599-7305
Site Reference ID/Investigator# 20801Philadelphia, Pennsylvania  19107
Site Reference ID/Investigator# 8360Nashville, Tennessee  37232-6307