45 Participants Needed

Pamiparib + Standard Care for Glioblastoma

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify if you must stop taking your current medications. However, there is a required washout period of at least 21 days after your last chemotherapy dose before starting the trial, provided you did not receive radiotherapy. Additionally, if you are using coumarin-derived anticoagulants, you must discontinue them before surgery. It's best to discuss your specific medications with the trial team.

Will I have to stop taking my current medications?

The trial does not specify if you must stop all current medications, but you cannot use coumarin-derived anticoagulants unless they can be stopped before surgery. If you have been on chemotherapy, a 21-day washout period (time without taking the medication) is required before starting the trial.

What safety data exists for Pamiparib and standard care in glioblastoma treatment?

The research indicates that Pamiparib, a PARP inhibitor, has been evaluated for its safety and efficacy in combination with temozolomide (TMZ) for brain tumors. Pamiparib shows strong anti-tumor synergy with TMZ and improved penetration across the blood-brain barrier. It has been tested in clinical trials, such as NCT03150862, for its potential in treating brain tumors. Additionally, a Phase I trial of Veliparib, another PARP inhibitor, with standard radiation and TMZ in glioblastoma patients was conducted to determine safety and maximum tolerated dose, suggesting a similar approach could be applicable to Pamiparib.12345

Is Pamiparib safe for use in humans?

Pamiparib, a drug being studied for brain tumors, has shown good safety in early trials, especially when combined with another drug called temozolomide. It is designed to work well in the brain and has been tested in combination with standard treatments for brain tumors.12345

Is the drug Pamiparib a promising treatment for glioblastoma?

Yes, Pamiparib is a promising drug for glioblastoma because it can effectively target brain tumors, works well with another cancer drug called temozolomide, and can cross the blood-brain barrier to reach the tumor.24678

What makes the drug Pamiparib unique for treating glioblastoma?

Pamiparib is unique because it is a potent PARP inhibitor that can cross the blood-brain barrier more effectively than other similar drugs, making it particularly promising for treating brain tumors like glioblastoma. It also shows strong synergy with temozolomide, a standard treatment for brain tumors, potentially overcoming resistance and improving treatment outcomes.24678

What data supports the idea that Pamiparib + Standard Care for Glioblastoma is an effective treatment?

The available research does not provide specific data on the effectiveness of Pamiparib combined with standard care for glioblastoma. Instead, it focuses on other drugs and treatments like buparlisib and iniparib, which are being tested for glioblastoma. There is also a study on Pamiparib's presence in human plasma and brain tumors, but it does not discuss its effectiveness for glioblastoma. Therefore, there is no direct evidence from the provided information to support the effectiveness of Pamiparib + Standard Care for glioblastoma.2691011

What data supports the effectiveness of the drug Pamiparib in treating glioblastoma?

Pamiparib is a drug that can be measured in both blood and brain tumors, which helps researchers understand how it works in the body. While specific effectiveness data for Pamiparib in glioblastoma is not provided, its ability to reach brain tumors is a positive sign for its potential use in treating this condition.2691011

Who Is on the Research Team?

NS

Nader Sanai, MD

Principal Investigator

Director, Ivy Brain Tumor Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Agreement to adhere to Lifestyle Considerations throughout study duration
I am not pregnant or cannot become pregnant due to menopause or surgery.
I had surgery for glioblastoma and have undergone standard treatment including radiation and temozolomide.
See 12 more

Exclusion Criteria

I have been treated with PARP inhibitors before.
Treatment with another investigational drug or other intervention within 30 days prior to enrollment or within 5 half-lives of the investigational product, whichever is longer
I haven't needed antibiotics or antivirals for an infection or high fever in the last 4 weeks.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 0

Participants receive pamiparib or olaparib for 4 days prior to surgical resection

1 week
1 visit (in-person)

Exploratory Phase 2

Participants receive pamiparib or olaparib in combination with 6-7 weeks of radiation therapy and pamiparib in combination with TMZ in the maintenance phase

6-7 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

  • Olaparib
  • Pamiparib
  • Radiation therapy
Trial Overview 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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Arm C Recurrent Glioblastoma Participant treated with OlaparibExperimental 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 Participant 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 Participant treated with PamiparibExperimental 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.

Pamiparib is already approved in China for the following indications:

🇨🇳
Approved in China as Pamiparib for:
  • Ovarian cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nader Sanai

Lead Sponsor

Trials
11
Recruited
440+

BeiGene

Industry Sponsor

Trials
216
Recruited
32,500+

Ivy Brain Tumor Center

Collaborator

Trials
12
Recruited
910+

Barrow Neurological Institute

Collaborator

Trials
27
Recruited
7,100+

Published Research Related to This Trial

In a phase II trial involving 65 patients with recurrent glioblastoma, the pan-PI3K inhibitor buparlisib showed minimal efficacy as a single agent, with only 8% of patients achieving 6-month progression-free survival.
Despite demonstrating significant brain penetration and some reduction in PI3K pathway activity in tumor tissue, the incomplete blockade of the pathway likely contributed to the lack of clinical effectiveness, suggesting that more effective PI3K inhibitors may be needed.
Buparlisib in Patients With Recurrent Glioblastoma Harboring Phosphatidylinositol 3-Kinase Pathway Activation: An Open-Label, Multicenter, Multi-Arm, Phase II Trial.Wen, PY., Touat, M., Alexander, BM., et al.[2020]
A highly sensitive and validated method was developed to measure pamiparib concentrations in human plasma and brain tumor tissue, allowing for accurate pharmacokinetic assessments in patients with glioma.
Pamiparib, a PARP1 and PARP2 inhibitor, demonstrated stability in plasma for at least 6 months at -80°C, indicating its potential for effective long-term treatment in glioma patients.
Development and validation of a liquid chromatography coupled with tandem mass spectrometry method for determining total and unbound pamiparib in human plasma and brain tumors.Jiang, J., Bao, X., Yue, Y., et al.[2023]
In a phase I study involving patients with newly diagnosed glioblastoma, the maximum tolerated dose (MTD) of buparlisib when combined with temozolomide was determined to be 80 mg/day, but the MTD for the combination with both temozolomide and radiotherapy could not be established due to significant dose-limiting toxicities.
The study reported high rates of adverse events, particularly nausea and fatigue, leading to treatment discontinuations, which contributed to Novartis's decision to halt further development of buparlisib for this indication.
Phase I, open-label, multicentre study of buparlisib in combination with temozolomide or with concomitant radiation therapy and temozolomide in patients with newly diagnosed glioblastoma.Wen, PY., Rodon, JA., Mason, W., et al.[2021]

Citations

Buparlisib in Patients With Recurrent Glioblastoma Harboring Phosphatidylinositol 3-Kinase Pathway Activation: An Open-Label, Multicenter, Multi-Arm, Phase II Trial. [2020]
Development and validation of a liquid chromatography coupled with tandem mass spectrometry method for determining total and unbound pamiparib in human plasma and brain tumors. [2023]
Phase I, open-label, multicentre study of buparlisib in combination with temozolomide or with concomitant radiation therapy and temozolomide in patients with newly diagnosed glioblastoma. [2021]
Phase II Study of Iniparib with Concurrent Chemoradiation in Patients with Newly Diagnosed Glioblastoma. [2020]
NRG/RTOG 0837: Randomized, phase II, double-blind, placebo-controlled trial of chemoradiation with or without cediranib in newly diagnosed glioblastoma. [2023]
Phase II trial of dacomitinib, a pan-human EGFR tyrosine kinase inhibitor, in recurrent glioblastoma patients with EGFR amplification. [2022]
Phase 2 trial of dasatinib in target-selected patients with recurrent glioblastoma (RTOG 0627). [2019]
Pamiparib is a potent and selective PARP inhibitor with unique potential for the treatment of brain tumor. [2021]
A Multi-Site Phase I Trial of Veliparib with Standard Radiation and Temozolomide in Patients with Newly Diagnosed Glioblastoma Multiforme (GBM). [2023]
Pamiparib in patients with locally advanced or metastatic HER2-negative breast cancer with germline BRCA mutations: a phase II study. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
PARP inhibition restores extrinsic apoptotic sensitivity in glioblastoma. [2018]
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