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PARP Inhibitor

Pamiparib + Standard Care for Glioblastoma

Phase < 1

Recruiting

Research Sponsored by Nader Sanai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Confirmed negative serum pregnancy test (β-hCG) before starting study treatment or participant who is no longer of childbearing potential due to surgical, chemical, or natural menopause

Participants who have had a prior resection of histologically diagnosed glioblastoma (WHO grade IV), defined as participants who have progressed on or following standard therapy, which includes maximal surgical resection, temozolomide, and fractionated radiotherapy. Participants will also need to have radiation planned as part of the post-surgical treatment plan

Must not have

Prior therapy with PARP inhibitors

Active infection or fever >38.5°C requiring systemic antibiotic, antifungal or antiviral therapy within 4 weeks of Day 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing pamiparib and olaparib combined with radiation therapy in patients with newly diagnosed and recurrent glioblastoma. These drugs help make cancer cells more sensitive to radiation by stopping them from repairing their DNA. The goal is to see if this combination can improve treatment outcomes for this aggressive brain cancer. Pamiparib is a potent and selective PARP inhibitor with unique potential for the treatment of brain tumors.

Who is the study for?

Adults with new or recurrent glioblastoma who've had surgery and are set for standard treatment, including radiation. They must be able to swallow pills, have good organ function, not be pregnant or breastfeeding, use effective contraception, and not have severe infections or certain chronic diseases. Those with prior PARP inhibitor treatments or allergic reactions to trial drugs cannot join.

What is being tested?

The study is testing Pamiparib in combination with radiotherapy for newly diagnosed glioblastoma without MGMT promoter methylation and for recurrent cases. Olaparib plus radiotherapy is also being tested for recurrent cases after assessing PK response in Phase 0 of the trial.

What are the potential side effects?

Potential side effects include digestive issues (nausea, vomiting), blood disorders (anemia), fatigue, possible allergic reactions to medication components, and other common drug-related adverse effects.

Eligibility Criteria

Inclusion Criteria

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

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I am not pregnant or cannot become pregnant due to menopause or surgery.

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I had surgery for glioblastoma and have undergone standard treatment including radiation and temozolomide.

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I am mostly self-sufficient and can carry out daily activities.

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I am 18 years old or older.

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I am scheduled for surgery for a new glioblastoma diagnosis and will follow standard treatment.

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I have a tumor that can be measured and is at least 1 cm in size.

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I can swallow pills.

Exclusion Criteria

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

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I have been treated with PARP inhibitors before.

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I haven't needed antibiotics or antivirals for an infection or high fever in the last 4 weeks.

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I haven't used, nor do I plan to use, certain strong medications before starting Olaparib.

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I do not have any active infections requiring IV antibiotics or known viral infections like HIV or active hepatitis B or C.

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I do not have severe infections or serious liver diseases like cirrhosis.

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I am currently using a blood thinner that can't be stopped before surgery.

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I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.

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I have had recent serious heart or stroke issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Systemic plasma PK profile parameters

Secondary study objectives

Adverse events

Deaths

Drug-related toxicity

+4 more

Side effects data

From 2013 Phase 3 trial • 397 Patients • NCT00004054

78%

Menopausal symptoms

60%

Urinary frequency

52%

Impotence

47%

Late RT Toxicity: Bladder: NOS

39%

Diarrhea NOS

27%

Late RT Toxicity: Bowel: NOS

26%

Fatigue

26%

Late RT Toxicity: Other GU: NOS

21%

Proctitis NOS

21%

Dysuria

14%

Libido decreased

14%

Dermatitis radiation NOS

12%

Late RT Toxicity: Other: NOS

12%

Late RT Toxicity: Other GI: NOS

12%

Hemoglobin decreased

12%

Alanine aminotransferase increased

Gynaecomastia

Urinary retention

Pain-other

Aspartate aminotransferase increased

Rectal bleeding

Constipation

Leukopenia NOS

Edema NOS

Hematuria present

Renal/GU-Other

Arthralgia

Blood creatinine increased

Dyspnea NOS

Dermatitis exfoliative NOS

Depression NEC

Nausea

Hyperglycemia NOS

Lymphopenia

Myalgia

Peripheral sensory neuropathy

Platelet count decreased

Hyponatremia

Hypocalcemia

Blood albumin decreased

Stomatitis

Weight decreased

Anorexia

Hematologic-Other

Neutropenia

Alopecia

100%

80%

60%

40%

20%

Study treatment Arm

Hormones and RT

Hormones and RT Plus Chemotherapy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm C Recurrent glioblastoma treated with olaparib - ARM CLOSEDExperimental Treatment3 Interventions

Arm C will be an exploratory arm in recurrent glioblastoma patients (rGBM) treated with Olaparib for 4 days prior to surgical resection. Patients who proceed to Phase 2 will receive olaparib administered orally BID continuously in combination with 6-7 weeks of radiation therapy and pamiparib in combination with TMZ in the maintenance phase.

Group II: Arm B Recurrent glioblastoma treated with pamiparibExperimental Treatment3 Interventions

Recurrent glioblastoma (rGBM) patients who are scheduled for surgery and expected to receive postoperative fractionated radiotherapy (RT) will be treated with pamiparib for 4 days prior to surgical resection. Patients who proceed to Phase 2 will receive pamiparib administered orally BID continuously in combination with 6-7 weeks of radiation therapy and pamiparib in combination with TMZ in the maintenance phase.

Group III: Arm A Newly diagnosed glioblastoma treated with pamiparib- ARM CLOSEDExperimental Treatment3 Interventions

Participants undergoing resection for a presumed newly diagnosed glioblastoma (nGBM) will be treated with pamiparib for 4 days prior to surgical resection. Patients who proceed to Phase 2 will receive pamiparib administered orally BID continuously in combination with 6-7 weeks of radiation therapy and pamiparib in combination with TMZ in the maintenance phase.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pamiparib

2017

Completed Phase 2

~750

Radiation therapy

2013

Completed Phase 3

~2850