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Alkylating agent

Paclitaxel for Ovarian Cancer (VELIA Trial)

Phase 3
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Neuropathy (sensory and motor) less than or equal to Grade 1
Participants with measurable disease or non-measurable disease are eligible. Participants may or may not have cancer-related symptoms
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 8 years from randomization.
Awards & highlights

VELIA Trial Summary

This trial found that adding veliparib to standard platinum-based chemotherapy and continuing it as maintenance therapy did not prolong PFS in patients with advanced BRCA-mutated ovarian cancer.

Eligible Conditions
  • Ovarian Cancer
  • Ovarian Neoplasms

VELIA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have mild or no nerve damage in your hands or feet.
Select...
You can participate in the study whether or not you have measurable signs of your disease or any symptoms related to your condition.

VELIA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 8 years from randomization.
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 8 years from randomization. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-Free Survival (PFS) in the BRCA-deficient Population
Progression-Free Survival (PFS) in the Homologous Recombination Deficiency Cohort
Progression-Free Survival (PFS) in the Intention-to-treat Population
Secondary outcome measures
Duane Retraction Syndrome
Change From Baseline in Disease Related Symptom (DRS) Score in the HRD Population
Change From Baseline in Disease Related Symptom (DRS) Score in the ITT Population
+1 more

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729
59%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Aspartate aminotransferase increased
9%
Musculoskeletal pain
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Insomnia
6%
Transaminases increased
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab

VELIA Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Veliparib + Carboplatin + Paclitaxel -> VeliparibExperimental Treatment3 Interventions
Participants will receive 150 mg veliparib orally twice a day in combination with carboplatin/paclitaxel for six 21-day cycles followed by 300/400 mg veliparib monotherapy orally twice a day for an additional thirty 21-day cycles.
Group II: Veliparib + Carboplatin + Paclitaxel -> PlaceboExperimental Treatment4 Interventions
Participants will receive 150 mg veliparib orally twice a day in combination with carboplatin/paclitaxel for six 21-day cycles followed by placebo monotherapy continuous dosing for an additional thirty 21-day cycles.
Group III: Placebo + Carboplatin + Paclitaxel -> PlaceboActive Control3 Interventions
Participants will receive placebo to veliparib orally twice a day in combination with carboplatin/paclitaxel for six 21-day cycles followed by placebo monotherapy continuous dosing for an additional thirty 21-day cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Veliparib
2012
Completed Phase 3
~4820
Paclitaxel
2011
Completed Phase 4
~5380
Carboplatin
2014
Completed Phase 3
~6670

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
945 Previous Clinical Trials
495,263 Total Patients Enrolled
5 Trials studying Ovarian Cancer
142 Patients Enrolled for Ovarian Cancer
Gynecologic Oncology Group;Australia New Zealand Gynaecological Oncology GroupUNKNOWN
AbbVie Inc.Study DirectorAbbVie
264 Previous Clinical Trials
100,417 Total Patients Enrolled
1 Trials studying Ovarian Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many willing participants are needed for this experiment?

"Presently, this trial is not seeking new patients. The study was first made public on 6/29/2015 and was most recently edited on 5/26/2022. However, there are 665 other clinical trials for patients with ovary cancer and 1243 trials for Paclitaxel that are actively recruiting."

Answered by AI

In how many different medical facilities is this test being administered currently?

"This trial has 100 total openings with centres including William Beaumont Hospital /ID# 139550 in Royal Oak, Univ Hosp Cleveland /ID# 139615 in Cleveland, and Mmcorc /Id# 139534 in Saint Louis Park, in addition to other research facilities."

Answered by AI

What other scientific studies have there been surrounding the use of Paclitaxel?

"City of Hope Comprehensive Cancer Center was the first to study paclitaxel in 1997. Out of the 1582 completed studies, 1243 are ongoing with a large portion taking place in Royal Oak, Michigan."

Answered by AI

What are some of the common conditions that doctors use Paclitaxel to address?

"Paclitaxel is an effective treatment for melanoma, neoplasm metastasis, and lymphoma, non-hodgkin."

Answered by AI

What are the key goals of this experiment?

"The primary focus of this trial is to explore the impacts of the medication on Progression-Free Survival (PFS) in the Intention-to-treat Population over a period of 28 months. Additionally, researchers will also be secondary outcomes including Change From Baseline in Disease Related Symptom (DRS) Score in the HRD Population and Overall Survival (OS)."

Answered by AI
Recent research and studies
~118 spots leftby Mar 2025