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Alkylating agents

Cyclophosphamide + Veliparib for Advanced Breast Cancer

Phase 1

Waitlist Available

Led By Joseph A Sparano

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

HER2/neu negative disease (performed on primary tumor and/or metastatic lesion using commercially available/approved assay in local institutional or reference laboratory), according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines

Disease that is metastatic (stage IV [TxNxM1]) or locally advanced and not amenable to potentially curative surgical resection (eg, clinical stage IIIB-C)

Must not have

Prior treatment with veliparib (ABT-888) or other PARP inhibitors (e.g., olaparib)

Patients who have radiotherapy within 3 weeks prior to entering the study or those who have not recovered from adverse events due to systemic agents administered more than 3 weeks earlier

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the side effects and best dose of two drugs, cyclophosphamide and veliparib, when given together to treat patients with breast cancer that has spread to other parts of the body.

Who is the study for?

This trial is for adults with advanced or metastatic HER2/neu negative breast cancer who've had prior chemotherapy. They must have a certain level of blood cells, no severe liver/kidney issues, and be able to take oral meds. Pregnant women, those unable to use contraception, or patients with recent seizures or bowel obstructions can't join.

What is being tested?

The study tests the combination of Cyclophosphamide (a chemo drug) and Veliparib (which blocks enzymes helping tumor growth) in treating advanced breast cancer. It aims to find the safest doses and observe side effects when these drugs are given together.

What are the potential side effects?

Potential side effects include nausea, vomiting, hair loss from cyclophosphamide; fatigue, low blood cell counts affecting immunity may occur too. Veliparib might cause digestive issues and affect bone marrow function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is not HER2 positive, as tested on my primary or metastatic tumor.

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My cancer has spread to other parts of my body or is advanced and cannot be removed by surgery.

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I can take care of myself but may not be able to do heavy physical work.

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I can swallow pills without any trouble.

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My hemoglobin level is 9 g/dl or higher.

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My breast cancer is confirmed and does not have the HER2 protein.

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My kidney function, measured by creatinine levels, is normal or nearly normal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have previously been treated with PARP inhibitors like veliparib or olaparib.

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I haven't had radiotherapy in the last 3 weeks or recovered from previous treatment side effects.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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I do not have active brain metastases requiring medication.

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I cannot take pills due to a blockage or problem in my intestines.

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I have had a seizure in the last 6 months and take medication for it.

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I cannot swallow whole capsules.

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I do not have conditions affecting my body's ability to absorb nutrients.

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I do not have HIV, hepatitis B or C, or any severe infection or illness.

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I have no allergies to veliparib or cyclophosphamide.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Recommended phase II dose of veliparib and cyclophosphamide

Secondary study objectives

Clinical response (complete or partial response) according to RECIST version 1.1

MacroH2A1.1 expression levels

Overall survival

+1 more

Side effects data

From 2024 Phase 3 trial • 509 Patients • NCT02163694

87%

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

HYPOCALCAEMIA

PARAESTHESIA

DEPRESSION

PRURITUS

MUCOSAL INFLAMMATION

HYPOPHOSPHATAEMIA

OROPHARYNGEAL PAIN

INFLUENZA LIKE ILLNESS

MUSCULOSKELETAL CHEST PAIN

DRY SKIN

VERTIGO

SINUSITIS

MUSCULOSKELETAL PAIN

DRY EYE

BLOOD ALKALINE PHOSPHATASE INCREASED

HYPERGLYCAEMIA

PALPITATIONS

TINNITUS

WEIGHT INCREASED

NEUROPATHY PERIPHERAL

DYSPNOEA EXERTIONAL

RHINORRHOEA

HYPERTENSION

LYMPHOEDEMA

TOOTHACHE

PAIN

HYPONATRAEMIA

GASTROOESOPHAGEAL REFLUX DISEASE

CHEST PAIN

DEHYDRATION

BREAST PAIN

PRODUCTIVE COUGH

ERYTHEMA

MUSCLE SPASMS

ABDOMINAL DISTENSION

INFLUENZA

RHINITIS

MALIGNANT NEOPLASM PROGRESSION

TACHYCARDIA

RESPIRATORY TRACT INFECTION VIRAL

FEBRILE NEUTROPENIA

PNEUMONIA

APPENDICITIS

CHOLELITHIASIS

ANAPHYLACTIC REACTION

NEUTROPENIC INFECTION

SEPSIS

SEIZURE

PULMONARY EMBOLISM

GASTRITIS

CELLULITIS

DEVICE RELATED INFECTION

ERYSIPELAS

VASCULAR DEVICE INFECTION

METASTASES TO MENINGES

100%

80%

60%

40%

20%

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

1Treatment groups

Experimental Treatment

Group I: Treatment (veliparib, cyclophosphamide)Experimental Treatment3 Interventions

Patients receive veliparib orally PO QD and cyclophosphamide PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

2010

Completed Phase 4

~2310

Veliparib

2012

Completed Phase 3

~4780