Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial is for people with newly diagnosed or recurrent glioblastoma, a type of brain cancer. It will have 30 participants and will be conducted in three phases. In the first phase, participants will be given a drug to see if it shrinks their tumor. If it does, they will move on to the second phase where they will be given the drug along with radiation therapy. The last phase is for people who have a certain protein in their tumor.
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.Check my eligibility
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.See study design
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 belowSelect...
I am not pregnant or cannot become pregnant due to menopause or surgery.
Select...
I had surgery for glioblastoma and have undergone standard treatment including radiation and temozolomide.
Select...
I am mostly self-sufficient and can carry out daily activities.
Select...
I am 18 years old or older.
Select...
I am scheduled for surgery for a new glioblastoma diagnosis and will follow standard treatment.
Select...
I have a tumor that can be measured and is at least 1 cm in size.
Select...
I can swallow pills.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Systemic plasma PK profile parameters
Secondary outcome measures
Adverse events
Deaths
Drug-related toxicity
+4 moreSide effects data
From 2013 Phase 3 trial • 397 Patients • NCT0000405478%
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 GI: NOS
12%
Late RT Toxicity: Other: NOS
12%
Hemoglobin decreased
12%
Alanine aminotransferase increased
9%
Gynaecomastia
8%
Urinary retention
7%
Pain-other
7%
Aspartate aminotransferase increased
6%
Rectal bleeding
6%
Constipation
6%
Leukopenia NOS
4%
Edema NOS
4%
Hematuria present
4%
Renal/GU-Other
3%
Arthralgia
3%
Blood creatinine increased
3%
Dyspnea NOS
3%
Dermatitis exfoliative NOS
2%
Nausea
2%
Hyperglycemia NOS
2%
Depression NEC
2%
Lymphopenia
2%
Myalgia
2%
Peripheral sensory neuropathy
1%
Stomatitis
1%
Platelet count decreased
1%
Blood albumin decreased
1%
Weight decreased
1%
Anorexia
1%
Hypocalcemia
1%
Hyponatremia
1%
Hematologic-Other
1%
Neutropenia
1%
Alopecia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Hormones and RT
Hormones and RT Plus Chemotherapy
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
Temozolomide
2010
Completed Phase 3
~1930
Olaparib
2007
Completed Phase 4
~2140
Find a Location
Who is running the clinical trial?
Nader SanaiLead Sponsor
8 Previous Clinical Trials
298 Total Patients Enrolled
6 Trials studying Glioblastoma
196 Patients Enrolled for Glioblastoma
BeiGeneIndustry Sponsor
175 Previous Clinical Trials
28,784 Total Patients Enrolled
1 Trials studying Glioblastoma
60 Patients Enrolled for Glioblastoma
Ivy Brain Tumor CenterOTHER
10 Previous Clinical Trials
347 Total Patients Enrolled
7 Trials studying Glioblastoma
223 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with PARP inhibitors before.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.I am willing and able to follow the trial's schedule and procedures.I haven't needed antibiotics or antivirals for an infection or high fever in the last 4 weeks.I am mostly self-sufficient and can carry out daily activities.I am 18 years old or older.I am scheduled for surgery for a new glioblastoma diagnosis and will follow standard treatment.I agree not to breastfeed during and for 6 months after the study.I have a tumor that can be measured and is at least 1 cm in size.My bone marrow and organs are functioning well.I can swallow pills.I haven't used, nor do I plan to use, certain strong medications before starting Olaparib.I have recovered from chemotherapy side effects, except for possible hair loss or mild nerve pain.I am a man who can father children and will use contraception during the study and for 6 months after.I do not have any active infections requiring IV antibiotics or known viral infections like HIV or active hepatitis B or C.I can understand and am willing to sign the consent form myself or have someone legally authorized to do so.I do not have severe infections or serious liver diseases like cirrhosis.I am currently using a blood thinner that can't be stopped before surgery.I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.You are allergic to any of the ingredients in the pamiparib or olaparib capsules.I have had recent serious heart or stroke issues.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A Newly diagnosed glioblastoma treated with pamiparib- ARM CLOSED
- Group 2: Arm B Recurrent glioblastoma treated with pamiparib
- Group 3: Arm C Recurrent glioblastoma treated with olaparib - ARM CLOSED
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this an original clinical experiment?
"Currently, there are 389 extant medical trials related to Radiation therapy in 1748 cities and 61 countries. The inaugural experiment involving this therapeutic approach was conducted by Schering-Plough back in 2002 with 60 participants; it obtained Phase 2 drug approval status before being concluded. Since then, a total of 414 such studies have been successfully completed."
Answered by AI
Are there any open spots remaining in this medical research project?
"According to the data hosted on clinicaltrials.gov, this medical trial is currently searching for participants. It was first posted in November of 2021 and recently updated in May of 2022."
Answered by AI
What conditions typically warrant radiotherapy as a treatment?
"Radiation therapy is a common approach for managing advanced directives, in addition to other illnesses such as progression disease and nitrosourea treatment. It can also be employed after chemotherapy treatments."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger