Veliparib With Carboplatin and Paclitaxel and as Continuation Maintenance Therapy in Subjects With Newly Diagnosed Stage III or IV, High-grade Serous, Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer



Status:Active, not recruiting
Conditions:Ovarian Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 99
Updated:10/20/2018
Start Date:July 14, 2015
End Date:May 28, 2020

Use our guide to learn which trials are right for you!

A Phase 3 Placebo-Controlled Study of Carboplatin/Paclitaxel With or Without Concurrent and Continuation Maintenance Veliparib (PARP Inhibitor) in Subjects With Previously Untreated Stages III or IV High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

The focus of this study is to evaluate the efficacy, safety, and tolerability of veliparib in
women with previously untreated, Stage III or IV, high-grade serous, epithelial ovarian,
fallopian tube, or primary peritoneal cancer.


Inclusion Criteria:

1. Histologic diagnosis of International Federation of Gynecology and Obstetrics (FIGO)
Stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal carcinoma,
with the appropriate tissue available for histologic evaluation.

2. High-grade serous adenocarcinoma

3. Willing to undergo testing for gBRCA.

4. Adequate hematologic, renal, and hepatic function.

5. Neuropathy (sensory and motor) less than or equal to Grade 1.

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

7. Participants who undergo primary cytoreductive surgery must be entered between 1 and
12 weeks after surgery. Participants undergoing interval surgery must have a tumor
sample confirming the histological diagnosis prior to enrollment.

8. Participants with measurable disease or non-measurable disease are eligible.
Participants may or may not have cancer-related symptoms.

9. Participant has one of the following available for PD analyses including somatic BRCA
testing: Archived diagnostic formalin-fixed paraffin embedded (FFPE) tumor tissue; or
tumor tissue biopsy collected prior to Cycle 1 Day 1.

Exclusion Criteria:

1. Endometrioid adenocarcinoma, carcinosarcoma, undifferentiated carcinoma, mixed
epithelial adenocarcinoma, adenocarcinoma not otherwise specified, mucinous
adenocarcinoma, clear cell adenocarcinoma, low-grade serous adenocarcinoma, or
malignant Brenner's tumor.

2. Participants with synchronous primary endometrial cancer, or a past history of
endometrial cancer unless all of the following conditions are met: endometrial cancer
stage not greater than IA, no vascular or lymphatic invasion, no poorly differentiated
subtypes including serous, clear cell, or other FIGO grade 3 lesions.

3. Participants with any evidence of other invasive malignancy being present within the
last 3 years (with the exception of non-melanoma skin cancer). Participants are also
excluded if their previous cancer treatment contraindicates this protocol's therapy.

4. Received prior radiotherapy to any portion of the abdominal cavity or pelvis.

5. Received prior chemotherapy for any abdominal or pelvic tumor.

6. Clinically significant uncontrolled condition(s).

7. Known history of allergic reaction to Cremophor-paclitaxel, carboplatin, Azo-Colourant
Tartrazine (also known as FD&C Yellow 5 or E102), Azo-Colourant Orange Yellow-S (also
known as FD&C Yellow 6 or E110) or known contraindications to any study supplied drug.

8. History or evidence upon physical examination of central nervous system (CNS) disease,
including primary brain tumor, any brain metastases, or history of cerebrovascular
accident (CVA, stroke), transient ischemic attack (TIA) within 6 months of Cycle 1 Day
1.
We found this trial at
140
sites
1200 Old York Road
Abington, Pennsylvania 19001
?
mi
from
Abington, PA
Click here to add this to my saved trials
319 South Manning Boulevard
Albany, New York 12208
?
mi
from
Albany, NY
Click here to add this to my saved trials
Albuquerque, New Mexico 87131
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Albuquerque, New Mexico 87106
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
1215 Duff Avenue
Ames, Iowa 50010
?
mi
from
Ames, IA
Click here to add this to my saved trials
3851 Piper Street
Anchorage, Alaska 99508
?
mi
from
Anchorage, AK
Click here to add this to my saved trials
100 Ridgefield Court
Asheville, North Carolina 28806
?
mi
from
Asheville, NC
Click here to add this to my saved trials
?
mi
from
Augusta, GA
Click here to add this to my saved trials
?
mi
from
Aurora, CO
Click here to add this to my saved trials
6204 Balcones Drive
Austin, Texas 78731
?
mi
from
Austin, TX
Click here to add this to my saved trials
6204 Balcones Drive
Austin, Texas 78731
?
mi
from
Austin, TX
Click here to add this to my saved trials
Baltimore, Maryland 21204
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
2401 West Belvedere Avenue
Baltimore, Maryland 21215
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
1609 Hospital Parkway
Bedford, Texas 76022
?
mi
from
Bedford, TX
Click here to add this to my saved trials
Bethlehem, Pennsylvania 18017
?
mi
from
Bethlehem, PA
Click here to add this to my saved trials
Birmingham, Alabama 35233
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
?
mi
from
Bronx, NY
Click here to add this to my saved trials
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
Buffalo, New York 14263
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
?
mi
from
Burlington, VT
Click here to add this to my saved trials
?
mi
from
Camden, NJ
Click here to add this to my saved trials
Chapel Hill, North Carolina 27514
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
96 Jonathan Lucas Street
Charleston, South Carolina 29425
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28204
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
200 Hawthorne Lane
Charlotte, North Carolina 28204
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
1215 Lee Street
Charlottesville, Virginia 22908
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
Chattanooga, Tennessee 37403
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
1653 West Congress Parkway
Chicago, Illinois 60612
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Chicago, Illinois 60637
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Cincinnati, Ohio 45219
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Cleveland, Ohio 44106
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Cleveland, Ohio 44195
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
9500 Euclid Avenue
Cleveland, Ohio 44195
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Coffs Harbour, New South Wales
?
mi
from
Coffs Harbour,
Click here to add this to my saved trials
1 Hospital Drive
Columbia, Missouri 65212
?
mi
from
Columbia, MO
Click here to add this to my saved trials
1831 5th Avenue
Columbus, Georgia 31904
?
mi
from
Columbus, GA
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Columbus, Ohio 43215
?
mi
from
Columbus, OH
Click here to add this to my saved trials
2540 East Street
Concord, California 94520
?
mi
from
Concord, CA
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Denver, CO
Click here to add this to my saved trials
Detroit, Michigan 48201
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Detroit, Michigan 48202
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Durham, North Carolina 27710
?
mi
from
Durham, NC
Click here to add this to my saved trials
?
mi
from
Eugene, OR
Click here to add this to my saved trials
Evanston, Illinois 60201
?
mi
from
Evanston, IL
Click here to add this to my saved trials
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
1300 Michigan Street Northeast
Grand Rapids, Michigan 49503
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
835 South Van Buren Street
Green Bay, Wisconsin 54301
?
mi
from
Green Bay, WI
Click here to add this to my saved trials
Hackensack, New Jersey 07601
?
mi
from
Hackensack, NJ
Click here to add this to my saved trials
Hinsdale, Illinois 60521
?
mi
from
Hinsdale, IL
Click here to add this to my saved trials
Honolulu, Hawaii 96826
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
Honolulu, Hawaii 96826
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
6411 Fannin Street
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
6565 Fannin Street
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Huntsville, Alabama 35805
?
mi
from
Huntsville, AL
Click here to add this to my saved trials
340 West 10th Street
Indianapolis, Indiana 46202
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Indianapolis, Indiana 46260
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
Jackson, Mississippi 39216
?
mi
from
Jackson, MS
Click here to add this to my saved trials
3901 Rainbow Boulevard
Kansas City, Kansas 66160
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
3737 Southern Boulevard
Kettering, Ohio 45429
?
mi
from
Kettering, OH
Click here to add this to my saved trials
La Jolla, California 92037
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
2000 Marcus Avenue
Lake Success, New York 11042
?
mi
from
Lake Success, NY
Click here to add this to my saved trials
3131 La Canada Street
Las Vegas, Nevada 89169
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Lebanon, New Hampshire 03756
?
mi
from
Lebanon, NH
Click here to add this to my saved trials
1740 Nicholasville Road
Lexington, Kentucky 40503
?
mi
from
Lexington, KY
Click here to add this to my saved trials
?
mi
from
Lexington, KY
Click here to add this to my saved trials
4301 West Markham Street
Little Rock, Arkansas 72205
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Long Beach, California 90806
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Los Angeles, California 90027
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Louisville, Kentucky 40241
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Louisville, Kentucky 40241
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Mayfield Heights, Ohio 44124
?
mi
from
Mayfield Heights, OH
Click here to add this to my saved trials
Miami, Florida 33136
?
mi
from
Miami, FL
Click here to add this to my saved trials
Milwaukee, Wisconsin 53226
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
?
mi
from
Mobile, AL
Click here to add this to my saved trials
1400 East Kincaid Street
Mount Vernon, Washington 98274
?
mi
from
Mount Vernon, WA
Click here to add this to my saved trials
201 North Mountain Road
New Britain, Connecticut 06053
?
mi
from
New Britain, CT
Click here to add this to my saved trials
New Haven, Connecticut 06510
?
mi
from
New Haven, CT
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73104
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
8303 Dodge Street
Omaha, Nebraska 68114
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Orange, California 92868
?
mi
from
Orange, CA
Click here to add this to my saved trials
Orange, California 92868
?
mi
from
Orange, CA
Click here to add this to my saved trials
Park Ridge, Illinois 60068
?
mi
from
Park Ridge, IL
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19104
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
130 South 9th Street
Philadelphia, Pennsylvania 19107
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19111
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19111
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15260
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Portland, Maine 04102
?
mi
from
Portland, ME
Click here to add this to my saved trials
Portland, Oregon 97227
?
mi
from
Portland, OR
Click here to add this to my saved trials
Providence, Rhode Island 02905
?
mi
from
Providence, RI
Click here to add this to my saved trials
Puyallup, Washington 93872
?
mi
from
Puyallup, WA
Click here to add this to my saved trials