DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Study of Imprime PGG® in Combination With Cetuximab in Subjects With Recurrent or Progressive KRAS Wild Type Colorectal Cancer

Information source: Biothera
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Colorectal Cancer

Intervention: Imprime PGG + cetuximab (Biological); Cetuximab (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Biothera

Overall contact:
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com

Summary

Study BT-CL-PGG-CRC1031 is a Phase 3, open-label, randomized, multi-center study. Qualified subjects, who have KRAS wild type (WT) colorectal cancer will be randomized in a 2: 1 ratio to treatment with either Imprime PGG and cetuximab or cetuximab alone. Subjects will be dosed until progression or discontinuation for some other reason. Efficacy will be assessed via Response Evaluation Criteria in Early Tumors 1. 1 (RECIST 1. 1); computed tomography (CT) scans will be conducted every 6 weeks. Safety, pharmacokinetics (PK), quality of life, and biomarker parameters will also be assessed.

Clinical Details

Official title: A Phase 3 Open-Label, Randomized, Multicenter Study of Imprime PGG® in Combination With Cetuximab (Erbitux®) in Subjects With Recurrent or Progressive KRAS Wild Type Colorectal Cancer

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Overall Survival (OS)

Secondary outcome:

Progression Free Survival (PFS)

Rate of complete response (CR)

Rate of partial response (PR)

Rate of overall response (CR + PR)

Safety and tolerability of the dosing regimen as measured by the incidence and severity of adverse events observed in study participants

Sparse pharmacokinetic profile of Imprime PGG will be determined to expand current Imprime PGG PK data

Change in Quality of Life

Detailed description: Study BT-CL-PGG-CRC1031 is a Phase 3, open-label, randomized, multi-center study. Qualified subjects, who have KRAS WT colorectal cancer will be randomized in a 2: 1 ratio to either: Arm 1: Imprime PGG and cetuximab or Arm 2: Cetuximab Approximately 795 subjects will be randomized into the study. Dosing will occur in 6-week cycles. Imprime PGG will be dosed at 4 mg/kg and will be administered weekly in each cycle (Weeks 1-6/Days 1, 8, 15, 22, 29, and 36) preceding the administration of cetuximab (Arm 1 only). The initial cetuximab dose (both arms) will be 400 mg/m2 on Cycle 1/Day 1 and subsequent doses will be 250 mg/m2 administered weekly in each cycle (Weeks 1-6/Days 1, 8, 15, 22, 29, and 36). Subjects will be dosed until progressive disease (PD) per RECIST 1. 1 or discontinuation of study drug for other reasons; e. g., safety. Following completion of the treatment period of the study, subjects will be monitored for survival until death or loss to follow-up. Tumor measurements and determination of tumor responses will be evaluated according to RECIST 1. 1. Safety, PK, quality of life, and biomarker parameters will also be assessed.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Is >18 years old; 2. Has recurrent or metastatic carcinoma of the colon or rectum with documented histological or cytological confirmation; 3. Must be KRAS WT; 4. Has measurable disease, defined as at least 1 tumor that fulfills the criteria for a target lesion according to RECIST 1. 1; 5. Has never received cetuximab or panitumumab, and has not received any treatment for colorectal cancer within 30 days prior to the first dose of study treatment under this protocol; 6. Has an Eastern Cooperative Oncology Group (ECOG) score of 0-1, with a life expectancy of >3 months; 7. Has received at least 2 prior chemotherapeutic regimens for colorectal cancer; 8. Has adequate bone marrow reserve as evidenced by:

- Absolute neutrophil count ≥1,500/μL

- Platelets ≥100,000/μL;

9. Has adequate renal function as evidenced by serum creatinine ≤2. 5 × the upper limit of normal (ULN) for the reference lab; 10. Has adequate hepatic function as evidenced by:

- Aspartate aminotransferase ≤3 × ULN for the reference lab (≤5 × ULN for subjects

with known hepatic metastases)

- Alanine aminotransferase ≤3 × ULN for the reference lab (≤5 × ULN for subjects

with known hepatic metastases)

- Bilirubin <1. 5 mg/dL or direct bilirubin <1. 0 mg/dL

- Serum Albumin >3. 0 gm/dL

11. Has read, understood and signed the informed consent form (ICF) approved by the Independent Review Board/Independent Ethics Committee (IRB/IEC); and 12. If the subject is a woman of childbearing potential or a fertile man, he/she must agree to use an effective form of contraception during the study and for 60 days following the last dose of study drug (an effective form of contraception is abstinence, a hormonal contraceptive, or a double-barrier method). Exclusion Criteria: 1. Has a known hypersensitivity to cetuximab, murine proteins, or any component of cetuximab; 2. Has a known hypersensitivity to baker's yeast or has an active yeast infection; 3. Has had previous exposure to Betafectin® or Imprime PGG; 4. Has an active, uncontrolled infection; 5. Has known untreated or symptomatic brain metastases; 6. Had a second malignancy within the previous 5 years, except for basal cell carcinoma, cervical intra-epithelial neoplasia or treated prostate cancer with a prostate-specific antigen (PSA) of <2. 0 ng/mL; 7. Has known human immunodeficiency virus or acquired immune deficiency syndrome, hepatitis B, hepatitis C, connective tissue disease, or other clinical diagnosis, ongoing or intercurrent illness that in the Investigators opinion should preclude the subject from participation; 8. If female, is pregnant or breast-feeding; 9. Is receiving concurrent standard and/or investigational anti-cancer therapy or has received such therapy within a period of 30 days prior to the first scheduled day of dosing (investigational therapy is defined as treatment for which there is currently no regulatory-authority-approved indication); or 10. Has previously received an organ or progenitor/stem cell transplant.

Locations and Contacts

Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com

Centre d' Oncologie de Gentilly, Nancy 54000, France; Active, not recruiting

Medizinisches Versorgungszentrum Ãrzteforum Seestrabe, Berlin 13347, Germany; Recruiting
Nick Niles, Phone: (908)453-3317, Email: nniles@cmedresearch.com
Alexander Schmittel, MD, Principal Investigator

Ãrzteforum Henningsdorf Darmzentrum Oberhavel, Hennigsdorf 16761, Germany; Recruiting
Nick Niles, Phone: (908)453-3317, Email: nniles@cmedresearch.com
Andrea Speidel, MD, Principal Investigator

Klinikum Kassel GmbH Medizinische Klinik IV Onkologie, Hämatologie, Immunologie, Kassel, Hessen 34125, Germany; Recruiting
Nick Niles, Phone: (908)453-3317, Email: nniles@cmedresearch.com
Martin Wolf, Prof, MD, Principal Investigator

Universitätsklinikum Köln - Studienzentrum der Klinik I für Innere Medizin, Koeln, Nordrhein Westfalen 50937, Germany; Recruiting
Nick Niles, Phone: (908)453-3317, Email: nniles@cmedresearch.com
Thomas Zander, MD, Principal Investigator

Schwerpunktpraxis für Hämatologie und Onkologie, Magdeburg 39104, Germany; Recruiting
Nick Niles, Phone: (908)453-3317, Email: nniles@cmedresearch.com
Hendrik Kroening, MD, Principal Investigator

Universitaetsklinikum Ulm, Ulm 89081, Germany; Recruiting
Nick Niles, Phone: (908)453-3317, Email: nniles@cmedresearch.com
Thomas Ettrich, MD, Principal Investigator

Petruskrankenhaus Wuppertal, Klinik fuer Innere Medizin II- Gastroenterologie, Hepatologie und Diabetologie, Wuppertal 42283, Germany; Recruiting
Nick Niles, Phone: (908)453-3317, Email: nniles@cmedresearch.com
Andreas Erhardt, MD, Principal Investigator

Fundacion de Investigacion de Diego, San Juan 00927, Puerto Rico; Active, not recruiting

Northwest Alabama Cancer Center, Florence, Alabama 35630, United States; Recruiting
Nick Niles, Email: nniles@cmedresearch.com
Hemant Patel, MD, Principal Investigator

Highlands Oncology Group, Bentonville, Arkansas 72703, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
J. Thaddeus Beck, MD, Principal Investigator

Pacific Medical Center, Anaheim, California 92801, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Veena Charu, MD, Principal Investigator

Comprehensive Blood and Cancer Center, Bakersfield, California 93309, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Ravi Patel, MD, Principal Investigator

Providence St. Joseph Medical Center, Burbank, California 91505, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Gregg Olsen, MD, Principal Investigator

UCSD Moores Cancer Center, La Jolla, California 92903, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Tony Reid, MD, PhD, Principal Investigator

Kenmar Research Institute, Los Angeles, California 90057, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Merrill Shum, MD, Principal Investigator

AMPM Research Clinic, Miami Gardens, Florida 33169, United States; Recruiting
Nick Niles, Email: nniles@cmedresearch.com
Luis Villa Jr., MD, Principal Investigator

MD Anderson Cancer Center, Orlando, Florida 32806, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Sajeve Thomas, MD, Principal Investigator

University of Hawaii Cancer Center, Honolulu, Hawaii 96813, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Jared Acoba, MD, Principal Investigator

Medical and Surgical Specialists, Galesburg, Illinois 61401, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Diane Prager, MD, Principal Investigator

Illinois Cancer Specialists, Niles, Illinois 60714, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Leonard Klein, MD, Principal Investigator

Indiana University Cancer Center, Beech Grove, Indiana 46237, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Nadeem Ikhlaque, MD, Principal Investigator

University of Louisville/James Brown Cancer Center, Louisville, Kentucky 40202, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Vivek Sharma, MD, Principal Investigator

Ochsner Clinic Foundation, New Orleans, Louisiana 70121, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Jyotsna Fuloria, MD, Principal Investigator

Dana Farber Cancer Institute, Boston, Massachusetts 02115, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Jeffrey Meyerhardt, MD, MPH, Principal Investigator

Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Jeffrey Meyerhardt, MD, MPH, Principal Investigator

Henry Ford Health System, Detroit, Michigan 48202, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Ira Wollner, MD, Principal Investigator

University of Minnesota, Minneapolis, Minnesota 55455, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Anne Blaes, MD, Principal Investigator

Ellis Fischel Cancer Center at University of Missouri- Columbia, Columbia, Missouri 65203, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Akm Mosharraf Hossain, MD, MPH, Principal Investigator

Oncology Hematology West PC dba Nebraska Cancer Specialists, Omaha, Nebraska 68130, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Ralph Hauke, MD, Principal Investigator

Hematology and Oncology Associates of Central NY, East Syracuse, New York 13057, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Benny Wong, MD, Principal Investigator

New York Oncology, Hematology, P.C., Hudson, New York 12534, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Linda DeMarco, MD, Principal Investigator

Signal Point Hematology/Oncology, Middletown, Ohio 45042, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Nandagopal Vrindavanam, MD, Principal Investigator

Toledo Community Oncology Program- Toledo Community Hospital, Toledo, Ohio 43623, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Rex B Mowat, MD, Principal Investigator

Willamette Valley Cancer Institute and Research Center, Eugene, Oregon 97401, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Glenn Buchanan, MD, Principal Investigator

Providence Portland Medical Center, Portland, Oregon 97213, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Todd Crocenzi, MD, Principal Investigator

Cancer Centers of the Carolinas, Spartanburg, South Carolina 29307, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Ki Y Chung, MD, Principal Investigator

The Jones Clinic, Germantown, Tennessee 38138, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Michael Jones, MD, Principal Investigator

Tennessee Cancer Specialists, Knoxville, Tennessee 37915, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Tracy Dobbs, MD, Principal Investigator

Texas Oncology-Amarillo, Amarillo, Texas 79106, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Leonardo Forero, MD, Principal Investigator

Mary Crowley Cancer Research Center, Dallas, Texas 75201, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
John Nemunaitis, MD, Principal Investigator

Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, Texas 75246, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Andrew McCollum, MD, Principal Investigator

Texas Oncology - Dallas Presbyterian Hospital, Dallas, Texas 75231, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Kristi McIntyre, MD, Principal Investigator

Texas Oncology Denton South, Denton, Texas 76210, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Sharad Jain, MD, Principal Investigator

Texas Oncology - Fort Worth, Fort Worth, Texas 76104, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Robert Ruxer, Jr., MD, Principal Investigator

Texas Oncology - Lewisville, Lewisville, Texas 75067, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Derrick Nguyen, MD, Principal Investigator

Texas Oncology-Seton Williamson, Round Rock, Texas 78665, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Vivian Cline-Burkhardt, MD, Principal Investigator

Cancer Care Centers of South Texas, San Antonio, Texas 78217, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Allyson Harroff, MD, Principal Investigator

Texas Oncology - Sherman, Sherman, Texas 75090, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Tammy Roque, MD, Principal Investigator

Texas Oncology - Tyler, Tyler, Texas 75702, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Donald Richards, MD, Principal Investigator

Northern Utah Associates, Ogden, Utah 84403, United States; Active, not recruiting

Virginia Oncology Associates, Newport News, Virginia 23606, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
David Chang, MD, Principal Investigator

Oncology and Hematology Associates of Southwest Virginia, Inc., dba Blue Ridge Cancer Care, Roanoke, Virginia 24014, United States; Recruiting
Nick Niles, Phone: 908-453-3317, Email: nniles@cmedresearch.com
Mark Kochenderfer, MD, Principal Investigator

Additional Information

Sponsor home page

Starting date: April 2011
Last updated: July 21, 2015

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017