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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Survival (OS)

Secondary outcome measures

Interaction With Optune Device

Objective Tumor Response

Overall Adverse Event Rates for Grade 3 or Higher Adverse Events

+1 more

Other outcome measures

Change in Quality of Life (QOL)

MGMT Status

Side effects data

From 2024 Phase 3 trial • 509 Patients • NCT02163694

87%

NEUTROPENIA

76%

THROMBOCYTOPENIA

76%

ANAEMIA

71%

NAUSEA

54%

ALOPECIA

50%

FATIGUE

46%

PERIPHERAL SENSORY NEUROPATHY

45%

DIARRHOEA

40%

LEUKOPENIA

36%

HEADACHE

34%

CONSTIPATION

34%

VOMITING

25%

ASTHENIA

24%

DECREASED APPETITE

24%

HYPOMAGNESAEMIA

21%

COUGH

20%

DYSPNOEA

20%

PAIN IN EXTREMITY

20%

DYSGEUSIA

19%

DIZZINESS

19%

OEDEMA PERIPHERAL

18%

BACK PAIN

18%

DYSPEPSIA

18%

INSOMNIA

18%

ARTHRALGIA

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

PRURITUS

HYPOCALCAEMIA

PARAESTHESIA

DEPRESSION

MUCOSAL INFLAMMATION

HYPOPHOSPHATAEMIA

OROPHARYNGEAL PAIN

MUSCULOSKELETAL CHEST PAIN

DRY SKIN

INFLUENZA LIKE ILLNESS

VERTIGO

SINUSITIS

MUSCULOSKELETAL PAIN

DRY EYE

BLOOD ALKALINE PHOSPHATASE INCREASED

LYMPHOEDEMA

RHINORRHOEA

PALPITATIONS

DYSPNOEA EXERTIONAL

TINNITUS

WEIGHT INCREASED

HYPERTENSION

HYPERGLYCAEMIA

NEUROPATHY PERIPHERAL

TOOTHACHE

PAIN

CHEST PAIN

DEHYDRATION

GASTROOESOPHAGEAL REFLUX DISEASE

BREAST PAIN

HYPONATRAEMIA

PRODUCTIVE COUGH

ERYTHEMA

MUSCLE SPASMS

ABDOMINAL DISTENSION

INFLUENZA

RHINITIS

MALIGNANT NEOPLASM PROGRESSION

TACHYCARDIA

RESPIRATORY TRACT INFECTION VIRAL

FEBRILE NEUTROPENIA

PNEUMONIA

SEPSIS

NEUTROPENIC INFECTION

GASTRITIS

SEIZURE

ANAPHYLACTIC REACTION

APPENDICITIS

PULMONARY EMBOLISM

CHOLELITHIASIS

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

~1930

Veliparib

2012

Completed Phase 3

~4820

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,932,706 Total Patients Enrolled

322 Trials studying Glioblastoma

22,668 Patients Enrolled for Glioblastoma

Jann N SarkariaPrincipal InvestigatorAlliance for Clinical Trials in Oncology

1 Previous Clinical Trials

54 Total Patients Enrolled

Media Library

Temozolomide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT02152982 — Phase 2 & 3

Glioblastoma Research Study Groups: Arm I (temozolomide, veliparib), Arm II (temozolomide, placebo)

Glioblastoma Clinical Trial 2023: Temozolomide Highlights & Side Effects. Trial Name: NCT02152982 — Phase 2 & 3

Temozolomide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02152982 — Phase 2 & 3

Frequently Asked Questions

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

Are there any available participant slots in this research project?

"As of now, this particular clinical trial is not looking for more patients. It was initially posted on December 15th, 2014 and updated for the last time on July 27th, 2022. There are 459 other trials concerning glioblastoma searching for patients and 237 involving Veliparib that are actively recruiting participants."

Answered by AI

Is this clinical trial widely available in North America?

"There are 100 different sites running this study, including Baptist Health Louisville in Louisville, Green Bay Oncology at Saint Vincent Hospital in Green Bay, and Green Bay Oncology Limited at Saint Mary's Hospital in Vancouver."

Answered by AI

Does literature on Veliparib exist outside of this particular trial?

"There are currently 237 studies being conducted worldwide that are investigating Veliparib. 26 of those live trials are in Phase 3, with the majority taking place in Seoul, Songpa. However, there are 7709 total locations running trials for this treatment."

Answered by AI

How many individuals are being research subjects in this investigation?

"Unfortunately, this particular medical trial is no longer recruiting patients. Although, it is worth mentioning that there are 459 other clinical trials for glioblastoma and 237 for Veliparib currently underway."

Answered by AI

What is the novel aspect of this clinical trial?

"There are 237 ongoing studies involving Veliparib in 1125 cities across 38 countries. The first clinical trial began in 2002 and, after completing Phase 2 drug approval, 60 patients were involved. 966 studies have been completed since then."

Answered by AI

What is the most common reason that Veliparib is given to patients?

"While typically used to treat nitrosourea treatment, veliparib has also shown efficacy in treating refractory neuroblastoma, mycosis fungoides, and other advanced directives."

Answered by AI

Recent research and studies

mgmtJournal

Delineation Of<i>mgmt</i>hypermethylation as a Biomarker for Veliparib-mediated Temozolomide-sensitizing Therapy of Glioblastoma

Gupta, Shiv K., Sani H. Kizilbash, Brett L. Carlson, Ann C. Mladek, Felix Boakye-Agyeman, Katrina K. Bakken, Jenny L. Pokorny, et al.. 2015. “Delineation Ofmgmthypermethylation as a Biomarker for Veliparib-mediated Temozolomide-sensitizing Therapy of Glioblastoma”. Journal of the National Cancer Institute. Oxford University Press (OUP). doi:10.1093/jnci/djv369.

clinicaltrials.govStudy

Temozolomide With or Without Veliparib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

2014. "Temozolomide With or Without Veliparib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02152982.

All > Recurrent Glioblastoma > Glioblastoma Multiforme