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
?
mi
from 43215
Vallejo, CA
Click here to add this to my saved trials
1200 Old York Road
Abington, Pennsylvania 19001
418
mi
from 43215
Abington, PA
Click here to add this to my saved trials
319 South Manning Boulevard
Albany, New York 12208
512
mi
from 43215
Albany, NY
Click here to add this to my saved trials
Albuquerque, New Mexico 87131
1331
mi
from 43215
Albuquerque, NM
Click here to add this to my saved trials
Albuquerque, New Mexico 87106
?
mi
from 43215
Albuquerque, NM
Click here to add this to my saved trials
1215 Duff Avenue
Ames, Iowa 50010
569
mi
from 43215
Ames, IA
Click here to add this to my saved trials
3851 Piper Street
Anchorage, Alaska 99508
3102
mi
from 43215
Anchorage, AK
Click here to add this to my saved trials
100 Ridgefield Court
Asheville, North Carolina 28806
307
mi
from 43215
Asheville, NC
Click here to add this to my saved trials
?
mi
from 43215
Augusta, GA
Click here to add this to my saved trials
1154
mi
from 43215
Aurora, CO
Click here to add this to my saved trials
6204 Balcones Drive
Austin, Texas 78731
1062
mi
from 43215
Austin, TX
Click here to add this to my saved trials
6204 Balcones Drive
Austin, Texas 78731
1062
mi
from 43215
Austin, TX
Click here to add this to my saved trials
Baltimore, Maryland 21204
?
mi
from 43215
Baltimore, MD
Click here to add this to my saved trials
2401 West Belvedere Avenue
Baltimore, Maryland 21215
340
mi
from 43215
Baltimore, MD
Click here to add this to my saved trials
1609 Hospital Parkway
Bedford, Texas 76022
924
mi
from 43215
Bedford, TX
Click here to add this to my saved trials
Bethlehem, Pennsylvania 18017
?
mi
from 43215
Bethlehem, PA
Click here to add this to my saved trials
Birmingham, Alabama 35233
?
mi
from 43215
Birmingham, AL
Click here to add this to my saved trials
?
mi
from 43215
Bronx, NY
Click here to add this to my saved trials
?
mi
from 43215
Brooklyn, NY
Click here to add this to my saved trials
Buffalo, New York 14263
?
mi
from 43215
Buffalo, NY
Click here to add this to my saved trials
?
mi
from 43215
Burlington, VT
Click here to add this to my saved trials
?
mi
from 43215
Camden, NJ
Click here to add this to my saved trials
Chapel Hill, North Carolina 27514
?
mi
from 43215
Chapel Hill, NC
Click here to add this to my saved trials
96 Jonathan Lucas Street
Charleston, South Carolina 29425
524
mi
from 43215
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28204
349
mi
from 43215
Charlotte, NC
Click here to add this to my saved trials
200 Hawthorne Lane
Charlotte, North Carolina 28204
349
mi
from 43215
Charlotte, NC
Click here to add this to my saved trials
1215 Lee Street
Charlottesville, Virginia 22908
277
mi
from 43215
Charlottesville, VA
Click here to add this to my saved trials
Chattanooga, Tennessee 37403
?
mi
from 43215
Chattanooga, TN
Click here to add this to my saved trials
1653 West Congress Parkway
Chicago, Illinois 60612
276
mi
from 43215
Chicago, IL
Click here to add this to my saved trials
Chicago, Illinois 60637
?
mi
from 43215
Chicago, IL
Click here to add this to my saved trials
Cincinnati, Ohio 45219
94
mi
from 43215
Cincinnati, OH
Click here to add this to my saved trials
Cleveland, Ohio 44106
?
mi
from 43215
Cleveland, OH
Click here to add this to my saved trials
Cleveland, Ohio 44195
129
mi
from 43215
Cleveland, OH
Click here to add this to my saved trials
9500 Euclid Avenue
Cleveland, Ohio 44195
129
mi
from 43215
Cleveland, OH
Click here to add this to my saved trials
Coffs Harbour, New South Wales
?
mi
from 43215
Coffs Harbour,
Click here to add this to my saved trials
1 Hospital Drive
Columbia, Missouri 65212
501
mi
from 43215
Columbia, MO
Click here to add this to my saved trials
1831 5th Avenue
Columbus, Georgia 31904
528
mi
from 43215
Columbus, GA
Click here to add this to my saved trials
?
mi
from 43215
Columbus, OH
Click here to add this to my saved trials
Columbus, Ohio 43215
0
mi
from 43215
Columbus, OH
Click here to add this to my saved trials
2540 East Street
Concord, California 94520
2083
mi
from 43215
Concord, CA
Click here to add this to my saved trials
?
mi
from 43215
Dallas, TX
Click here to add this to my saved trials
?
mi
from 43215
Dallas, TX
Click here to add this to my saved trials
?
mi
from 43215
Denver, CO
Click here to add this to my saved trials
Detroit, Michigan 48201
?
mi
from 43215
Detroit, MI
Click here to add this to my saved trials
Detroit, Michigan 48202
165
mi
from 43215
Detroit, MI
Click here to add this to my saved trials
Durham, North Carolina 27710
?
mi
from 43215
Durham, NC
Click here to add this to my saved trials
?
mi
from 43215
Eugene, OR
Click here to add this to my saved trials
Evanston, Illinois 60201
?
mi
from 43215
Evanston, IL
Click here to add this to my saved trials
?
mi
from 43215
Fort Worth, TX
Click here to add this to my saved trials
1300 Michigan Street Northeast
Grand Rapids, Michigan 49503
247
mi
from 43215
Grand Rapids, MI
Click here to add this to my saved trials
835 South Van Buren Street
Green Bay, Wisconsin 54301
403
mi
from 43215
Green Bay, WI
Click here to add this to my saved trials
Hackensack, New Jersey 07601
?
mi
from 43215
Hackensack, NJ
Click here to add this to my saved trials
Hinsdale, Illinois 60521
?
mi
from 43215
Hinsdale, IL
Click here to add this to my saved trials
Honolulu, Hawaii 96826
4500
mi
from 43215
Honolulu, HI
Click here to add this to my saved trials
Honolulu, Hawaii 96826
?
mi
from 43215
Honolulu, HI
Click here to add this to my saved trials
6411 Fannin Street
Houston, Texas 77030
994
mi
from 43215
Houston, TX
Click here to add this to my saved trials
6565 Fannin Street
Houston, Texas 77030
995
mi
from 43215
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from 43215
Houston, TX
Click here to add this to my saved trials
Huntsville, Alabama 35805
?
mi
from 43215
Huntsville, AL
Click here to add this to my saved trials
340 West 10th Street
Indianapolis, Indiana 46202
167
mi
from 43215
Indianapolis, IN
Click here to add this to my saved trials
Indianapolis, Indiana 46260
?
mi
from 43215
Indianapolis, IN
Click here to add this to my saved trials
?
mi
from 43215
Iowa City, IA
Click here to add this to my saved trials
Jackson, Mississippi 39216
?
mi
from 43215
Jackson, MS
Click here to add this to my saved trials
3901 Rainbow Boulevard
Kansas City, Kansas 66160
620
mi
from 43215
Kansas City, KS
Click here to add this to my saved trials
3737 Southern Boulevard
Kettering, Ohio 45429
64
mi
from 43215
Kettering, OH
Click here to add this to my saved trials
La Jolla, California 92037
?
mi
from 43215
La Jolla, CA
Click here to add this to my saved trials
2000 Marcus Avenue
Lake Success, New York 11042
493
mi
from 43215
Lake Success, NY
Click here to add this to my saved trials
3131 La Canada Street
Las Vegas, Nevada 89169
1757
mi
from 43215
Las Vegas, NV
Click here to add this to my saved trials
Lebanon, New Hampshire 03756
609
mi
from 43215
Lebanon, NH
Click here to add this to my saved trials
1740 Nicholasville Road
Lexington, Kentucky 40503
156
mi
from 43215
Lexington, KY
Click here to add this to my saved trials
?
mi
from 43215
Lexington, KY
Click here to add this to my saved trials
4301 West Markham Street
Little Rock, Arkansas 72205
624
mi
from 43215
Little Rock, AR
Click here to add this to my saved trials
Long Beach, California 90806
?
mi
from 43215
Long Beach, CA
Click here to add this to my saved trials
Los Angeles, California 90027
1973
mi
from 43215
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from 43215
Los Angeles, CA
Click here to add this to my saved trials
Louisville, Kentucky 40241
178
mi
from 43215
Louisville, KY
Click here to add this to my saved trials
Louisville, Kentucky 40241
178
mi
from 43215
Louisville, KY
Click here to add this to my saved trials
Mayfield Heights, Ohio 44124
?
mi
from 43215
Mayfield Heights, OH
Click here to add this to my saved trials
Miami, Florida 33136
?
mi
from 43215
Miami, FL
Click here to add this to my saved trials
Milwaukee, Wisconsin 53226
?
mi
from 43215
Milwaukee, WI
Click here to add this to my saved trials
?
mi
from 43215
Mobile, AL
Click here to add this to my saved trials
1400 East Kincaid Street
Mount Vernon, Washington 98274
2007
mi
from 43215
Mount Vernon, WA
Click here to add this to my saved trials
201 North Mountain Road
New Britain, Connecticut 06053
545
mi
from 43215
New Britain, CT
Click here to add this to my saved trials
New Haven, Connecticut 06510
?
mi
from 43215
New Haven, CT
Click here to add this to my saved trials
?
mi
from 43215
New York, NY
Click here to add this to my saved trials
481
mi
from 43215
New York, NY
Click here to add this to my saved trials
?
mi
from 43215
New York, NY
Click here to add this to my saved trials
?
mi
from 43215
New York, NY
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73104
?
mi
from 43215
Oklahoma City, OK
Click here to add this to my saved trials
8303 Dodge Street
Omaha, Nebraska 68114
687
mi
from 43215
Omaha, NE
Click here to add this to my saved trials
Orange, California 92868
?
mi
from 43215
Orange, CA
Click here to add this to my saved trials
Orange, California 92868
?
mi
from 43215
Orange, CA
Click here to add this to my saved trials
Park Ridge, Illinois 60068
?
mi
from 43215
Park Ridge, IL
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19104
?
mi
from 43215
Philadelphia, PA
Click here to add this to my saved trials
130 South 9th Street
Philadelphia, Pennsylvania 19107
416
mi
from 43215
Philadelphia, PA
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19111
?
mi
from 43215
Philadelphia, PA
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19111
420
mi
from 43215
Philadelphia, PA
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15260
?
mi
from 43215
Pittsburgh, PA
Click here to add this to my saved trials
Portland, Maine 04102
?
mi
from 43215
Portland, ME
Click here to add this to my saved trials
Portland, Oregon 97227
?
mi
from 43215
Portland, OR
Click here to add this to my saved trials
Providence, Rhode Island 02905
?
mi
from 43215
Providence, RI
Click here to add this to my saved trials