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PARP Inhibitor
Veliparib +/− Carboplatin for Breast Cancer
Phase 2
Waitlist Available
Led By Joanne Mortimer
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 13 years
Awards & highlights
No Placebo-Only Group
Summary
This trial looks at how well veliparib and carboplatin work to treat stage IV breast cancer.
Who is the study for?
This trial is for women with advanced (stage III or IV) breast cancer that can't be removed by surgery and isn't responding to standard treatments. Participants must have completed any prior chemotherapy at least 3 weeks before, be over 18, have a life expectancy over four months, not be pregnant, and have a specific BRCA mutation. They shouldn't have had platinum-based therapy recently unless it was over a year ago.
What is being tested?
The study is testing the effectiveness of Veliparib alone versus combined with Carboplatin in treating advanced breast cancer. Veliparib targets enzymes needed for tumor growth while Carboplatin interferes with tumor cell division and spread. The goal is to determine if combining these drugs improves treatment outcomes.
What are the potential side effects?
Veliparib may cause nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems. Carboplatin can also lead to similar side effects including kidney issues, hearing changes, and allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 13 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 13 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Post-progression response rate (Phase II)
Response rate
Secondary study objectives
Incidence of adverse events
Progression-free survival (Phase II)
Second progression-free survival (Phase II)
Side effects data
From 2024 Phase 3 trial • 509 Patients • NCT0216369487%
NEUTROPENIA
76%
ANAEMIA
76%
THROMBOCYTOPENIA
71%
NAUSEA
54%
ALOPECIA
50%
FATIGUE
46%
PERIPHERAL SENSORY NEUROPATHY
45%
DIARRHOEA
40%
LEUKOPENIA
36%
HEADACHE
34%
CONSTIPATION
34%
VOMITING
25%
ASTHENIA
24%
HYPOMAGNESAEMIA
24%
DECREASED APPETITE
21%
COUGH
20%
DYSPNOEA
20%
PAIN IN EXTREMITY
20%
DYSGEUSIA
19%
DIZZINESS
19%
OEDEMA PERIPHERAL
18%
DYSPEPSIA
18%
ARTHRALGIA
18%
BACK PAIN
18%
INSOMNIA
18%
EPISTAXIS
17%
MYALGIA
17%
DRUG HYPERSENSITIVITY
16%
ABDOMINAL PAIN UPPER
16%
PYREXIA
16%
NASOPHARYNGITIS
16%
ALANINE AMINOTRANSFERASE INCREASED
14%
ABDOMINAL PAIN
14%
UPPER RESPIRATORY TRACT INFECTION
14%
ASPARTATE AMINOTRANSFERASE INCREASED
13%
LYMPHOPENIA
13%
STOMATITIS
12%
HYPOKALAEMIA
12%
URINARY TRACT INFECTION
12%
BONE PAIN
11%
ANXIETY
11%
RASH
11%
HOT FLUSH
10%
DRY MOUTH
9%
HYPOCALCAEMIA
9%
PARAESTHESIA
9%
DEPRESSION
9%
PRURITUS
9%
MUCOSAL INFLAMMATION
8%
HYPOPHOSPHATAEMIA
8%
OROPHARYNGEAL PAIN
7%
INFLUENZA LIKE ILLNESS
7%
MUSCULOSKELETAL CHEST PAIN
7%
DRY SKIN
7%
VERTIGO
7%
SINUSITIS
7%
MUSCULOSKELETAL PAIN
7%
DRY EYE
7%
BLOOD ALKALINE PHOSPHATASE INCREASED
6%
HYPERGLYCAEMIA
6%
PALPITATIONS
6%
TINNITUS
6%
WEIGHT INCREASED
6%
NEUROPATHY PERIPHERAL
6%
DYSPNOEA EXERTIONAL
6%
RHINORRHOEA
6%
HYPERTENSION
6%
LYMPHOEDEMA
6%
TOOTHACHE
6%
PAIN
5%
HYPONATRAEMIA
5%
GASTROOESOPHAGEAL REFLUX DISEASE
5%
CHEST PAIN
5%
DEHYDRATION
5%
BREAST PAIN
5%
PRODUCTIVE COUGH
5%
ERYTHEMA
5%
MUSCLE SPASMS
5%
ABDOMINAL DISTENSION
5%
INFLUENZA
5%
RHINITIS
4%
MALIGNANT NEOPLASM PROGRESSION
4%
TACHYCARDIA
4%
RESPIRATORY TRACT INFECTION VIRAL
3%
FEBRILE NEUTROPENIA
2%
PNEUMONIA
1%
APPENDICITIS
1%
CHOLELITHIASIS
1%
ANAPHYLACTIC REACTION
1%
NEUTROPENIC INFECTION
1%
SEPSIS
1%
SEIZURE
1%
PULMONARY EMBOLISM
1%
GASTRITIS
1%
CELLULITIS
1%
DEVICE RELATED INFECTION
1%
ERYSIPELAS
1%
VASCULAR DEVICE INFECTION
1%
METASTASES TO MENINGES
100%
80%
60%
40%
20%
0%
Study treatment Arm
Veliparib Placebo With Carboplatin and Paclitaxel
Veliparib With Carboplatin and Paclitaxel
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Safety Lead-In Phase (veliparib, carboplatin)Experimental Treatment6 Interventions
Patients receive veliparib PO BID twice daily on days 1-21 of each cycle and carboplatin IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.
Group II: Phase II (veliparib, carboplatin)Experimental Treatment6 Interventions
Patients receive veliparib PO BID on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon progression, patients are taken off treatment for 1 week and may then continue to recieve veliparib along with carboplatin IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 3
~2020
Computed Tomography
2017
Completed Phase 2
~2740
Veliparib
2012
Completed Phase 3
~4780
Carboplatin
2014
Completed Phase 3
~6120
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,920 Previous Clinical Trials
41,016,863 Total Patients Enrolled
Joanne MortimerPrincipal InvestigatorCity of Hope Comprehensive Cancer Center
7 Previous Clinical Trials
151 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can swallow pills without breaking or crushing them.I do not have severe health issues that are poorly controlled.I am a woman with advanced breast cancer that cannot be surgically removed and standard treatments are not effective.I cannot take platinum-based chemotherapy due to health reasons.My doctor expects me to live more than four months.Your liver enzymes (AST and ALT) must not be too high, unless you have evidence of cancer spread to the liver, in which case they can be a little higher.I haven't had seizures or needed steroids for my brain metastases for over 3 months.I finished my last chemotherapy for metastatic disease 3 weeks ago and any radiation or hormonal treatment 1 week ago.I am a woman aged 18 or older.I have had platinum-based or PARP inhibitor treatments, but it's been over a year since I last received them.My kidney function is normal or nearly normal.I am allergic to ABT-888 or similar medications.I haven't had cancer other than non-melanoma skin cancer or stage I ovarian cancer in the last 5 years.You have a disease that can be measured using specific criteria.I do not have an active severe infection or known HIV, hepatitis B, or hepatitis C.I can take care of myself and am up and about more than half of my waking hours.Your ANC (a type of white blood cell) count is at least 1,500 per microliter of blood.Your platelet count is at least 100,000 per microliter.I have brain metastases needing medication or causing symptoms.I have a confirmed harmful BRCA mutation from a certified lab.Your total bilirubin level should be within a certain range, not higher than 1.5 times the normal limit at the medical facility.
Research Study Groups:
This trial has the following groups:- Group 1: Phase II (veliparib, carboplatin)
- Group 2: Safety Lead-In Phase (veliparib, carboplatin)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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