A Randomized, Open-label Phase 2 Study of EC145 Single-agent and the Combination of EC145 Plus Docetaxel Versus Docetaxel Alone in Participants With Folate-receptor Positive [FR(++)] Second Line NSCLC
In a phase 2 study of single-agent EC145 in heavily pretreated non-small cell lung cancer
(NSCLC) patients (median of 3 prior chemotherapy regimens), the subgroup with all target
lesions expressing the folate receptor [FR(++)] had a promising prolonged progression free
survival of 7.1 months and overall survival of 10.9 months. Furthermore, in-vitro and
in-vivo studies in KB models showed good synergism between EC145 and docetaxel.
This study will clinically assess for the first time the combination of EC145+docetaxel (Arm
B) in participants with NSCLC (Stage IIIB or IV). This is an international, multicenter,
centrally randomized, open-label, phase 2 study comparing single-agent EC145,
EC145+docetaxel combination therapy, and single-agent docetaxel in participants with NSCLC
who have failed one prior chemotherapy and who have all target lesions expressing the folate
receptor [FR(++)]. Eligible participants will be randomized in a 1:1:1 ratio into either Arm
A (single-agent EC145), Arm B (EC145+docetaxel combination therapy), or Arm C (single-agent
docetaxel) and will receive treatment until either disease progression or intolerable
toxicity.
This study is intended to investigate if there is a sufficiently strong efficacy signal in
order to proceed with phase 3 testing with either EC145 single-agent and/or the combination
of EC145+docetaxel against the standard-of-care docetaxel in second-line NSCLC.
This study will clinically assess for the first time the combination of EC145+docetaxel (Arm
B) in participants with NSCLC (Stage IIIB or IV). Therefore, an interim safety analysis will
be done by the DSMB after 5 participants in Arm B have completed 1 cycle of therapy, and the
second analysis after 15 participants in Arm B have completed 1 cycle of therapy.
If the majority of the enrolled participants (more than 70%) require a dose reduction of one
level (to 60 mg/m2), the dose will be reduced for the remainder of the study. If the
majority of the participants (more than 70%) require 2 dose reductions (to 40 mg/m2), the
sponsor will consider discontinuing the combination arm.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival(PFS)based on investigator assessment using RECIST v1.1
Disease assessment will be conducted via CT/ MRI every 6 weeks while on study. Participants who come off study due to any other reason except progression of disease or death will be followed via CT/ MRI every 6 weeks until disease progression or until start of new therapy.
From date of baseline disease assessment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 26 months
No
Binh Nguyen, MD, PhD
Study Director
Endocyte
United States: Food and Drug Administration
EC-FV-07
NCT01577654
March 2011
June 2014
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
University of Colorado Cancer Center | Denver, Colorado 80262 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Ingalls Memorial Hospital | Harvey, Illinois 60426 |
University of Chicago Medical Center | Chicago, Illinois 60637 |
Gabrail Cancer Center | Canton, Ohio 44718 |
Oregon Health and Science University | Portland, Oregon 97201 |
Providence Cancer Center | Southfield, Michigan 48075 |
Providence Saint Joseph Medical Center | Burbank, California 91505-4866 |
Ut Southwestern Medical Center | Dallas, Texas 75390 |
Carle Foundation dba Carle Cancer Center | Urbana, Illinois 61801 |
Ventura County Hematology Oncology Specialists | Oxnard, California 93030 |
Cancer Care Specialists of Central Illinois | Decatur, Illinois 62256 |
Horizon Oncology Center | Lafayette, Indiana 47905 |
Willamette Valley Cancer Institute and Research Center | Springfield, Oregon 97477 |
Texas Oncology - Tyler | Tyler, Texas 75702 |
Columbia Basin Hematology and Oncology | Kennewick, Washington 99336 |
Penn State Hershey Cancer Institute | Hershey, Pennsylvania 17033 |
Illinois CancerCare, P.C. | Bloomington, Illinois 61701 |
Texas Oncology-Beaumont, Mamie McFaddin Ward Cancer Center | Beaumont, Texas 77702 |
Texas Oncology - Plano East | Plano, Texas 75075-7787 |
Texas Oncology-Arlington South | Arlington, Texas 76014 |
Indiana University - Simon Cancer Center | Indianapolis, Indiana 46202 |
Texas Oncology-Bedford | Bedford, Texas 76022 |
The University of Arizona Cancer Center at UMC-North | Tucson, Arizona 85719 |
PMK Medical Group, Inc. DBA Ventura County Hematology Oncology Specialists | Oxnard, California 93030 |
Rush University Mecial Center | Chicago, Illinois 60612 |
Kellogg Cancer Center | Evanston, Illinois |
Carle Cancer Center, Mills Breast Cancer Institute | Urbana, Illinois |
University of Maryland-Marlene and Stewart Greenebaum Cancer Center | Baltimore, Maryland 21201 |
Barbara Ann Karmanos Cancer Insitute | Detroit, Michigan |
Texas Oncology-South Austin | Austin, Texas 78731 |