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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

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ClinicalTrials.gov Identifier: NCT02470585
Recruitment Status : Active, not recruiting
First Posted : June 12, 2015
Last Update Posted : April 27, 2018
Sponsor:
Collaborators:
Gynecologic Oncology Group
Australia New Zealand Gynaecological Oncology Group
Information provided by (Responsible Party):
AbbVie

Brief Summary:
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 or disease Intervention/treatment Phase
Ovarian Cancer Ovarian Neoplasm Drug: Veliparib Drug: Paclitaxel Drug: Carboplatin Other: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Actual Study Start Date : July 14, 2015
Estimated Primary Completion Date : April 4, 2019
Estimated Study Completion Date : May 28, 2020


Arm Intervention/treatment
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: Paclitaxel
Intravenous infusion

Drug: Carboplatin
Intravenous infusion

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
Drug: Paclitaxel
Intravenous infusion

Drug: Carboplatin
Intravenous infusion

Other: Placebo
Capsule

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: Paclitaxel
Intravenous infusion

Drug: Veliparib
Capsule

Drug: Carboplatin
Intravenous infusion




Primary Outcome Measures :
  1. Progression-Free survival (PFS) [ Time Frame: Approximately 3 years from first dose of study drug ]
    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 :
  1. Overall Survival (OS) [ Time Frame: Approximately 6 years from first dose of study drug ]
    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.

  2. Disease Related Symptom (DRS) scores [ Time Frame: Up to 2 years or disease progression from randomization, whichever is later ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02470585


  Show 212 Study Locations
Sponsors and Collaborators
AbbVie
Gynecologic Oncology Group
Australia New Zealand Gynaecological Oncology Group
Investigators
Study Director: AbbVie Inc. AbbVie

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02470585     History of Changes
Other Study ID Numbers: M13-694
2014-005070-11 ( EudraCT Number )
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

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

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