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

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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.
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Abington, Pennsylvania 19001
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Albany, New York 12208
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1215 Duff Avenue
Ames, Iowa 50010
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Anchorage, Alaska 99508
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Asheville, North Carolina 28806
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Austin, Texas 78731
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Baltimore, Maryland 21215
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Bedford, Texas 76022
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Charleston, South Carolina 29425
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Charlotte, North Carolina 28204
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Charlotte, North Carolina 28204
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Charlottesville, Virginia 22908
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Chicago, Illinois 60612
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Cleveland, Ohio 44195
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Columbia, Missouri 65212
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Columbus, Georgia 31904
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Green Bay, Wisconsin 54301
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