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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by AbbVie
Sponsor:
Collaborators:
Gynecologic Oncology Group
Australia New Zealand Gynaecological Oncology Group
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT02470585
First received: June 10, 2015
Last updated: July 18, 2016
Last verified: July 2016
  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.

Condition Intervention Phase
Ovarian Cancer
Ovarian Neoplasm
Other: Placebo
Drug: Veliparib
Drug: Carboplatin
Drug: Paclitaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Progression-Free survival (PFS) [ Time Frame: Approximately 3 years from first dose of study drug ] [ Designated as safety issue: No ]
    Defined as the number of days from the date that the subject was randomized to the date the subject experiences an event of disease progression or to the date of death (all causes of mortality) if disease progression is not reached.


Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Approximately 6 years from first dose of study drug ] [ Designated as safety issue: No ]
    Time to death for a given subject will be defined as the number of days from the date that the subject was randomized to the date of the subject's death.

  • Disease Related Symptom (DRS) scores [ Time Frame: Up to 2 years or disease progression from randomization, whichever is later ] [ Designated as safety issue: No ]

Estimated Enrollment: 1100
Study Start Date: July 2015
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Arm 1
Carboplatin/paclitaxel plus placebo for six 21-day cycles followed by placebo maintenance therapy for up to 30 additional 21-day cycles
Other: Placebo
Capsule
Drug: Carboplatin
Intravenous infusion
Drug: Paclitaxel
Intravenous infusion
Experimental: Arm 2
Carboplatin/paclitaxel plus veliparib for six 21-day cycles followed by placebo maintenance therapy for up to 30 additional 21-day cycles
Drug: Veliparib
Capsule
Drug: Carboplatin
Intravenous infusion
Drug: Paclitaxel
Intravenous infusion
Experimental: Arm 3
Carboplatin/paclitaxel plus veliparib for six 21-day cycles followed by veliparib maintenance therapy for up to 30 additional 21-day cycles
Drug: Veliparib
Capsule
Drug: Carboplatin
Intravenous infusion
Drug: Paclitaxel
Intravenous infusion

  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 and 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02470585

Contacts
Contact: Terri L Leahy +1 847-935-3179 terri.leahy@abbvie.com
Contact: Katie Papp +1 847-938-3188 katherine.papp@abbvie.com

  Show 217 Study Locations
Sponsors and Collaborators
AbbVie
Gynecologic Oncology Group
Australia New Zealand Gynaecological Oncology Group
Investigators
Study Director: Stacie P Shepherd, MD AbbVie
  More Information

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02470585     History of Changes
Other Study ID Numbers: M13-694  2014‐005070‐11 
Study First Received: June 10, 2015
Last Updated: July 18, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by AbbVie:
Overall Survival
BRCA
Veliparib
Ovarian
Poly Adenosine Diphosphate (ADP) - Ribose Polymerase (PARP)
ABT-888
Paclitaxel
Carboplatin
Randomized

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Paclitaxel
Veliparib
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 25, 2016