GlioblastomaEarly Phase 1NCT04614909
Study of Pamiparib in Newly Diagnosed and rGBM
A Early Phase 1 study testing Pamiparib, Olaparib and Radiation therapy in people with Glioblastoma and Glioblastoma Multiforme, run by Nader Sanai at 1 site in United States.
Trial summary
This is an open-label, single-center Phase 0/2 study that will enroll up to 30 participants with newly diagnosed (N=12) and recurrent glioblastoma (N=18). The trial will be composed of a Phase 0 component (subdivided into Arm A, Arm B, and Arm C), and an Exploratory Phase 2 component. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Glioblastoma Multiforme, Glioblastoma Multiforme, Adult
- What is being tested?
- Pamiparib, Olaparib and Radiation therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2021to 28 May 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants undergoing resection for a suspected newly diagnosed glioblastoma who are also planned to follow the standard regimen or;
- 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.
- Participants must have measurable disease preoperatively, defined as at least 1 contrast-enhancing lesion, with 2 perpendicular measurements of at least 1 cm.
- Ability to understand and the willingness to sign a written informed consent document (personally or by the legally authorized representative, if applicable).
- Participant has voluntarily agreed to participate by giving written informed consent (personally or via legally authorized representative(s), and assent if applicable). Written informed consent for the protocol must be obtained prior to any screening procedures. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other procedures.
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- Age ≥18 at time of consent
- Have a performance status (PS) of ≤2 on the Eastern Cooperative Oncology (Group (ECOG) scale (Oken et al. 1982)
- Ability to swallow oral medications.
- Participant has adequate bone marrow and organ function
- 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.
- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to treatment and agreement to use such a method during study participation and for an additional 6 months after the end of treatment administration.
- For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner and for an additional 6 months after the end of treatment administration. Avoid sperm donation for duration of the study and for an additional 6 months after the end of treatment administration.
- Agreement to adhere to Lifestyle Considerations throughout study duration.
- Participants who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events [CTCAE] Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to Day 1. A washout period of at least 21 days is required between last chemotherapy dose and Day 1 (provided the participant did not receive radiotherapy).
- Females of child-bearing potential must agree not to breastfeed starting at screening, throughout the study period and for 6 months after final study drug administration
Who cannot join
- Current use of coumarin-derived anticoagulant for treatment, prophylaxis or otherwise, that cannot be discontinued prior to surgery. Therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed.
- Pregnancy or lactation.
- Known allergic reactions to components of the pamiparib capsule/olaparib.
- Active infection or fever >38.5°C requiring systemic antibiotic, antifungal or antiviral therapy within 4 weeks of Day 1.
- Known to have active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and active and chronic hepatitis.
- Known active systemic bacterial infection (requiring intravenous [IV] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C [for example, hepatitis B surface antigen positive]. Screening is not required for enrollment.
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- Any of the following cardiovascular criteria:
- Current evidence of cardiac ischemia
- Current symptomatic pulmonary embolism
- Acute myocardial infarction ≤ 6 months prior to Day 1
- Heart failure of New York Heart Association Classification III or IV (see Section 13.2) ≤ 6 months prior to Day 1
- Grade ≥ 2 ventricular arrhythmia ≤ 6 months prior to Day 1
- Cerebral vascular accident (CVA) or transient ischemic attack (TIA) ≤ 6 months prior to Day 1
- Participant has myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of MDS/AML
- Participant has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).
- Prior therapy with PARP inhibitors.
- 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.
- For Olaparib participants: Use or anticipated need for food and drugs known to be strong or moderate CYP3A inducers or inhibitors ≤10 days (or ≤5 half-lives, whichever is the shorter) prior to day 1.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
About this study
Official title: A Phase 0/2 Clinical Trial of Pamiparib in Newly-Diagnosed and Recurrent Glioblastoma Patients
This is an open-label, single-center Phase 0/2 study that will enroll up to 30 participants with newly diagnosed (N=12) and recurrent glioblastoma (N=18). The trial will be composed of a Phase 0 component (subdivided into Arm A, Arm B, and Arm C), and an Exploratory Phase 2 component. Participants with tumors demonstrating a PK response in the Phase 0 component of the study will graduate to an exploratory Phase 2 component that combines therapeutic dosing of pamiparib plus fractionated radiotherapy (for unmethylated MGMT promoter newly-diagnosed cases), pamiparib plus fractionated radiotherapy (for recurrent cases) or Olaparib plus fractionated radiotherapy (recurrent cases).
- Being tested
- Pamiparib, Olaparib, Radiation therapy, Temozolomide
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PamiparibDrug
60mg administered orally BID for 4 days prior to surgical resection
OlaparibDrug
200mg administered orally BID for 4 days prior to surgical resection
Radiation therapyRadiation
Patients in Phase 2 will receive 6-7 weeks of radiation therapy per standard of care
TemozolomideDrug
Arm A and Arm B participants after RT is completed, will receive pamiparib in combination with TMZ (newly diagnosed participants). Arm C participants will receive olaparib with TMZ.
| Study group | Role | What they receive |
|---|---|---|
| Arm A Newly-diagnosed Glioblastoma Participant treated with Pamiparib | Experimental | 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. Receives: Drug: Pamiparib; Radiation: Radiation therapy; Drug: Temozolomide |
| Arm B Recurrent Glioblastoma Participant treated with Pamiparib | Experimental | 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. Receives: Drug: Pamiparib; Radiation: Radiation therapy; Drug: Temozolomide |
| Arm C Recurrent Glioblastoma Participant treated with Olaparib | Experimental | 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. Receives: Drug: Olaparib; Radiation: Radiation therapy; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic plasma PK profile parameters
Total and unbound pamiparib concentration in enhancing and non-enhancing tumor tissue.
Measured: Day 4 Intra-operative sample
Secondary outcomes (7)
Progression-free survival in participants with demonstrated PK effects
6-month progression-free survival (PFS6) rate measured from time of surgery to date of recurrence
Measured: 6 months
Overall survival
Median overall survival
Measured: 24 months
Drug-related toxicity
Incidence of drug-related toxicity
Measured: 24 months
Adverse events
Number of Adverse Events through study completion, assessed up to 24 months
Measured: 24 months
Treatment-emergent adverse events
Number of treatment-emergent adverse events
Measured: 24 months
Deaths
Number and incidence of deaths
Measured: 24 months
Pharmacodynamics (PD) of pamiparib
Quantification of PAR concentration in tumor homogenates
Measured: Day 4 Intra-operative sample
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start11 Jan 2021
- Primary completion21 Jul 2023
- Study completion28 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nader Sanai
- Sponsor type
- University, hospital or other
- Collaborators
- Barrow Neurological Institute, Ivy Brain Tumor Center, BeiGene
- Responsible party
- Sponsor-investigator, Nader Sanai, St. Joseph's Hospital and Medical Center, Phoenix
- Investigators
- Nader Sanai, MD, Principal investigator, Director, Ivy Brain Tumor Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614909
- Sponsor's protocol ID
- 2020-12
- Status last verified
- May 2026
- First submitted
- 28 Oct 2020
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 0/2 Clinical Trial of Pamiparib in Newly-Diagnosed and Recurrent Glioblastoma Patients
- ClinicalTrials.gov ID
- NCT04614909
- Acronym / sponsor ID
- 2020-12
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Nader SanaiUniversity, hospital or other
- Collaborators
- Barrow Neurological Institute, Ivy Brain Tumor Center, BeiGene
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 21 Jul 2023 (actual)
- Study completion
- 28 May 2025 (actual)
- First posted
- 4 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, single-center Phase 0/2 study that will enroll up to 30 participants with newly diagnosed (N=12) and recurrent glioblastoma (N=18). The trial will be composed of a Phase 0 component (subdivided into Arm A, Arm B, and Arm C), and an Exploratory Phase 2 component. Participants with tumors demonstrating a PK response in the Phase 0 component of the study will graduate to an exploratory Phase 2 component that combines therapeutic dosing of pamiparib plus fractionated radiotherapy (for unmethylated MGMT promoter newly-diagnosed cases), pamiparib plus fractionated radiotherapy (for recurrent cases) or Olaparib plus fractionated radiotherapy (recurrent cases).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A Newly-diagnosed Glioblastoma Participant treated with Pamiparib | Experimental | Drug: Pamiparib, Radiation: Radiation therapy, Drug: TemozolomideParticipants 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. |
| Arm B Recurrent Glioblastoma Participant treated with Pamiparib | Experimental | Drug: Pamiparib, Radiation: Radiation therapy, Drug: TemozolomideRecurrent 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. |
| Arm C Recurrent Glioblastoma Participant treated with Olaparib | Experimental | Drug: Olaparib, Radiation: Radiation therapy, Drug: TemozolomideArm 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Participants undergoing resection for a suspected newly diagnosed glioblastoma who are also planned to follow the standard regimen or;
- 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.
- Participants must have measurable disease preoperatively, defined as at least 1 contrast-enhancing lesion, with 2 perpendicular measurements of at least 1 cm.
- Ability to understand and the willingness to sign a written informed consent document (personally or by the legally authorized representative, if applicable).
- Participant has voluntarily agreed to participate by giving written informed consent (personally or via legally authorized representative(s), and assent if applicable). Written informed consent for the protocol must be obtained prior to any screening procedures. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.
Key exclusion criteria (18 listed)
- Current use of coumarin-derived anticoagulant for treatment, prophylaxis or otherwise, that cannot be discontinued prior to surgery. Therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed.
- Pregnancy or lactation.
- Known allergic reactions to components of the pamiparib capsule/olaparib.
- Active infection or fever >38.5°C requiring systemic antibiotic, antifungal or antiviral therapy within 4 weeks of Day 1.
- Known to have active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and active and chronic hepatitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pamiparib60mg administered orally BID for 4 days prior to surgical resection | Drug | Arm A Newly-diagnosed Glioblastoma Participant treated with Pamiparib, Arm B Recurrent Glioblastoma Participant treated with Pamiparib |
| Olaparib200mg administered orally BID for 4 days prior to surgical resection | Drug | Arm C Recurrent Glioblastoma Participant treated with Olaparib |
| Radiation therapyPatients in Phase 2 will receive 6-7 weeks of radiation therapy per standard of care | Radiation | Arm A Newly-diagnosed Glioblastoma Participant treated with Pamiparib, Arm B Recurrent Glioblastoma Participant treated with Pamiparib, Arm C Recurrent Glioblastoma Participant treated with Olaparib |
| TemozolomideArm A and Arm B participants after RT is completed, will receive pamiparib in combination with TMZ (newly diagnosed participants). Arm C participants will receive olaparib with TMZ. | Drug | Arm A Newly-diagnosed Glioblastoma Participant treated with Pamiparib, Arm B Recurrent Glioblastoma Participant treated with Pamiparib, Arm C Recurrent Glioblastoma Participant treated with Olaparib |
Primary outcome
Systemic plasma PK profile parameters
Time frame: Day 4 Intra-operative sample
Total and unbound pamiparib concentration in enhancing and non-enhancing tumor tissue.
7 secondary outcomes
Progression-free survival in participants with demonstrated PK effects
Time frame: 6 months
Overall survival
Time frame: 24 months
Drug-related toxicity
Time frame: 24 months
Adverse events
Time frame: 24 months
Treatment-emergent adverse events
Time frame: 24 months
Deaths
Time frame: 24 months
Pharmacodynamics (PD) of pamiparib
Time frame: Day 4 Intra-operative sample
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nader Sanai, MD principal investigator
Director, Ivy Brain Tumor Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Pamiparib, Olaparib and Radiation therapy in people with Glioblastoma and Glioblastoma Multiforme, run by Nader Sanai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systemic plasma PK profile parameters (time frame: Day 4 Intra-operative sample). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.