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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
Overall Recruitment Status: Active, currently enrolling
 
Official Title
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
 
Region Sponsors
Colorado
AbbVie
 
Acronym KP IRB No.
1226023
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Females with Ovarian Cancer; Ovarian Neoplasm
 
Purpose
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.
 
Detailed Description
 
Gender Age Limit
Female 18 - 99 years
 
Inclusion Criteria
  • 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
  • High-grade serous adenocarcinoma
  • Willing to undergo testing for gBRCA
  • Adequate hematologic, renal, and hepatic function
  • Neuropathy (sensory and motor) less than or equal to Grade 1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Participants who undergo primary cytoreductive surgery must be entered between 1 and 12 weeks after surgery. Participants undergoing interval surgery must have a needle core biopsy confirming the histological diagnosis prior to enrollment
  • Participants with measurable disease and non-measurable disease are eligible. Participants may or may not have cancer-related symptoms
  • 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
  • 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
  • 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
  • Participants with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last 3 years. Participants are also excluded if their previous cancer treatment contraindicates this protocol's therapy
  • Received prior radiotherapy to any portion of the abdominal cavity or pelvis
  • Received prior chemotherapy for any abdominal or pelvic tumor
  • Clinically significant uncontrolled condition(s)
  • 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
  • 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.

 
Keywords and/or Specific Medical Conditions
  • Adnexal Diseases
  • Mitosis Modulators
  • Albumin-Bound Paclitaxel
  • Molecular Mechanisms of Pharmacological Action
  • Antimitotic Agents
  • Neoplasms
  • Antineoplastic Agents
  • Neoplasms by Site
  • Antineoplastic Agents, Phytogenic
  • Ovarian Diseases
  • Carboplatin
  • Paclitaxel
  • Endocrine Gland Neoplasms
  • Poly(ADP-ribose) Polymerase Inhibitors
  • Endocrine System Diseases
  • Tubulin Modulators
  • Enzyme Inhibitors
  • Urogenital Neoplasms
  • Genital Diseases, Female
  • Veliparib
  • Genital Neoplasms, Female
  • Ovarian Neoplasms
  • Gonadal Disorders
  • Oncology (Adult)
 
KP Clinical Facility
  • Franklin Medical Offices - Denver
  • Lone Tree Medical Offices - Lone Tree
  • Rock Creek Medical Offices - Lafayette
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Alex Menter, MD
Contact Information:
- Mabel D Peters, BS
-303-764-8523
-Mabel.D.Peters@kp.org
-Franklin Medical Offices - Denver


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