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Alkylating agents

Temozolomide + Veliparib for Glioblastoma

Phase 2 & 3

Waitlist Available

Led By Jann N Sarkaria

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

Confirmation by central pathology review of WHO grade IV glioblastoma or gliosarcoma

Must have completed standard radiotherapy and concomitant TMZ therapy as defined and determined by the study oncologist

Must not have

Patients with GBM with oligodendroglial features that are 1p19q codeleted

Patients with treatment-related acute myeloid leukemia (AML) (t-AML)/myelodysplastic syndrome (MDS) or with features suggestive of AML/MDS

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Summary

This trial is studying the combination of temozolomide and veliparib compared to temozolomide alone in treating patients with newly diagnosed glioblastoma multiforme.

Who is the study for?

This trial is for adults with newly diagnosed glioblastoma multiforme or gliosarcoma. Participants must have proper liver function, enough tissue for testing, and their tumor must not be a specific subtype (1p19q codeleted). They should also have normal blood cell counts and kidney function. Those with certain genetic features of the tumor that make it less likely to respond to treatment are excluded.

What is being tested?

The study is examining if adding Veliparib to Temozolomide chemotherapy improves outcomes in treating brain cancer compared to Temozolomide alone. It's a randomized trial, meaning patients are put into the two different treatment groups by chance.

What are the potential side effects?

Temozolomide can cause nausea, fatigue, hair loss, constipation, headache and memory problems. Veliparib may add risks like low blood cell counts leading to infection or bleeding issues, fatigue and digestive troubles.

Eligibility Criteria

Inclusion Criteria

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

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My brain tumor is confirmed as grade IV glioblastoma or gliosarcoma.

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I have finished standard radiotherapy and TMZ therapy as my doctor required.

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My blood and organ functions are normal, and I haven't had a blood transfusion in the last 28 days.

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I have been diagnosed with a specific type of brain tumor that is not 1p19q codeleted.

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My MGMT test result is not unmethylated.

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I have not had a bone marrow or cord blood transplant.

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My tumor has MGMT promoter hypermethylation.

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

Exclusion Criteria

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

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My GBM cancer has specific genetic features (1p19q codeleted).

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I have AML or MDS, possibly caused by previous treatments.

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I have had a condition where my lymphocytes grow abnormally.

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I have a history of cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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

Overall Survival (OS)

Secondary study objectives

Interaction With Optune Device

Objective Tumor Response

Overall Adverse Event Rates for Grade 3 or Higher Adverse Events

+1 more

Other study objectives

Change in Quality of Life (QOL)

MGMT Status

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

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm I (temozolomide, veliparib)Experimental Treatment4 Interventions

Patients receive temozolomide PO QD on days 1-5 and veliparib PO BID on days 1-7. Treatment repeats every 28 days for 6 cycles in the absence of disease progression (confirmed progression) or unacceptable toxicity.

Group II: Arm II (temozolomide, placebo)Placebo Group4 Interventions

Patients receive temozolomide as in Arm I and placebo PO BID on days 1-7. Treatment repeats every 28 days for 6 cycles in the absence of disease progression (confirmed progression) or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Temozolomide

2010

Completed Phase 3

~1880

Veliparib

2012

Completed Phase 3

~4780