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Alkylating agent

Veliparib + Topotecan ± Carboplatin for Leukemia

Phase 1

Waitlist Available

Led By Keith W Pratz

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

Chronic myelomonocytic leukemia meeting specific criteria

ECOG performance status 0-2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 at pre-treatment, .25, .5, 1, 2, 4, 6, and 8 hours after veliparib and day 4 at pre-veliparib, .25, .5, 1, 2, 4, 6, and 8 hours after the first dose of veliparib

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the side effects and best dose of veliparib when given with topotecan hydrochloride and carboplatin in treating patients with relapsed or refractory acute leukemia, high-risk myelodysplasia, or aggressive myeloproliferative disorders.

Who is the study for?

This trial is for patients with certain blood cancers like acute leukemia, high-risk myelodysplasia, or aggressive myeloproliferative disorders who have relapsed or didn't respond to previous treatments. Participants must be physically stable enough to consent and follow the protocol, not have had more than three prior chemotherapy regimens, and should not be pregnant or breastfeeding. They must use effective contraception during the study.

What is being tested?

The trial is testing how well veliparib works alongside topotecan hydrochloride with or without carboplatin in treating specific blood cancers. Veliparib blocks enzymes that cancer cells need to grow while the other drugs aim to kill cancer cells by stopping their division.

What are the potential side effects?

Potential side effects include reactions related to liver function (elevated AST/ALT), issues with blood clotting (disseminated intravascular coagulation), infections requiring antibiotics control, heart function impacts measured by LVEF, and general risks associated with chemotherapy such as fatigue, nausea, hair loss.

Eligibility Criteria

Inclusion Criteria

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

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I have chronic myelomonocytic leukemia.

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I can take care of myself and perform daily activities.

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I do not have an active blood clotting disorder.

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I do not have any ongoing infections that aren't under control.

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I have never had seizures.

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I have never taken ABT-888.

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I am not receiving any other cancer treatments.

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I do not have active graft-versus-host disease.

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My cancer returned after it was initially gone with treatment.

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I have been diagnosed with aggressive myeloproliferative disease or acute myeloid leukemia.

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My blood disorder is in an aggressive, high-risk stage.

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I am HIV positive but not on antiretroviral therapy.

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I do not have any other severe illnesses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 at pre-treatment, .25, .5, 1, 2, 4, 6, and 8 hours after veliparib and day 4 at pre-veliparib, .25, .5, 1, 2, 4, 6, and 8 hours after the first dose of veliparib

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 at pre-treatment, .25, .5, 1, 2, 4, 6, and 8 hours after veliparib and day 4 at pre-veliparib, .25, .5, 1, 2, 4, 6, and 8 hours after the first dose of veliparib

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 at pre-treatment, .25, .5, 1, 2, 4, 6, and 8 hours after veliparib and day 4 at pre-veliparib, .25, .5, 1, 2, 4, 6, and 8 hours after the first dose of veliparib for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Pharmacokinetics and pharmacodynamics of veliparib

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, topotecan hydrochloride, carboplatin)Experimental Treatment4 Interventions

Patients receive veliparib orally twice daily on days 1-8, 1-14, or 1-21 and topotecan hydrochloride with or without carboplatin IV continuously over 120 hours on days 3-7. Treatment repeats every 28-63 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Topotecan Hydrochloride

2013

Completed Phase 3

~6270

Carboplatin

2014

Completed Phase 3

~6120