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A Pivotal Phase III Study to Evaluate Overall Survival Using MABp1 as a Monotherapy in Metastatic Colorectal Cancer Patients With Cachexia


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Metastatic Colorectal Cancer, Cachexia, Weight Loss

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Trial Information

A Pivotal Phase III Study to Evaluate Overall Survival Using MABp1 as a Monotherapy in Metastatic Colorectal Cancer Patients With Cachexia


Inclusion Criteria:



1. Subjects with pathologically confirmed colorectal carcinoma that is metastatic or
unresectable and which is refractory to standard therapy. To be considered
refractory, a subject must have failed both an oxaliplatin and an irinotecan based
regimen.

2. Weight loss of ≥5% over the last 6 months.

3. Eastern Cooperative Oncology Group (ECOG) performance status 0,1, or 2.

4. Palliative radiation and/or chemotherapy are permitted after the initial 2 week
washout period.

Exclusion Criteria:

1. Mechanical obstruction that would prevent adequate oral nutritional intake.

2. Serious uncontrolled medical disorder, or active infection, that would impair the
ability of the patient to receive protocol therapy.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall Survival

Outcome Description:

The difference in median overall survival will be compared between the two arms.

Outcome Time Frame:

baseline to 18 months

Safety Issue:

No

Principal Investigator

Aminah Jatoi, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Food and Drug Administration

Study ID:

2012-PT023

NCT ID:

NCT01767857

Start Date:

March 2013

Completion Date:

December 2014

Related Keywords:

  • Metastatic Colorectal Cancer
  • Cachexia
  • Weight Loss
  • Pivotal
  • Cachexia
  • Colorectal
  • Survival
  • Phase 3
  • Cachexia
  • Colorectal Neoplasms
  • Weight Loss

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
Montefiore Medical CenterBronx, New York  10467-2490
Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Mid Dakota ClinicBismarck, North Dakota  58501
Karmanos Cancer InstituteDetroit, Michigan  48201
Lewis Hall Singletary Oncology CenterThomasville, Georgia  31792
Innovative Clinical Research InstituteDowney, California  90241
UT Medical Center Cancer InstituteKnoxville, Tennessee  37920