A Study Assessing Pamiparib With Radiation and/or Temozolomide (TMZ) in Participants With Newly D… (NCT03150862) | Clinical Trial Compass
CompletedPhase 1/2
A Study Assessing Pamiparib With Radiation and/or Temozolomide (TMZ) in Participants With Newly Diagnosed or Recurrent Glioblastoma
United States, Australia, France116 participantsStarted 2017-07-24
Plain-language summary
The primary objective of this study is to evaluate the safety, efficacy and clinical activity of Pamiparib in combination with radiation therapy (RT) and/or temozolomide (TMZ) in participants with newly diagnosed or recurrent/refractory glioblastoma.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥ 18 years old.
. Confirmed diagnosis of glioblastoma (WHO Grade IV).
. Agreement to provide archival tumor tissue for exploratory biomarker analysis
. Ability to undergo serial MRIs.
. Eastern Cooperative Oncology Group (ECOG) status ≤ 1.
. Adequate hematologic and end-organ function
. Females of childbearing potential and non-sterile males must agree to use highly effective methods of birth control throughout the course of study and at least up to 6 months after last dosing.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase 1b Escalation Phase: Number of Participants With Dose-Limiting Toxicities (DLTs) as Assessed by CTCAE
Timeframe: Arm A:Day 1 Pamiparib dose until 4 weeks after the last RT; Arm B: Day 1 of Pamiparib and Temozolomide until 4 weeks after the last RT; Arm C: 1st cycle of 28 days
2
Phase 1b Escalation Phase: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as Assessed by CTCAE
Timeframe: From initiation of study treatment (for TEAE) or from the date informed consent has been signed (for SAE), until 30 days after last study treatment or initiation of new anticancer therapy, whichever occurs first (up to 3 years and 7.5 months)
3
Phase 1b Escalation Phase Arm C: Number of Participants With Clinically Relevant Changes in Vital Signs and Clinical Laboratory Measurements
Timeframe: From the date of first dose up to end of study (EOS) visit (up to 3 years and 7.5 months)
4
Phase 2 Arm A: Modified Disease Control Rate (DCR) as Assessed by Response Assessment in Neuro-Oncology (RANO) Criteria
Timeframe: From the date of first dose up to first documentation of disease progression while participant is alive ( up to 3 years and 7.5 months)
5
Phase 2 Arm C: Objective Response Rate (ORR) as Assessed Using RANO Criteria
Timeframe: From the date of first dose up to first documentation of disease progression while participant is alive (up to 3 years and 7.5 months)
. Prior chemotherapy, biologic therapy, immunotherapy or investigational agents ≤21 days prior to start of study treatment.
. Toxicity of ≥ Grade 2 from prior therapy.
. Major surgery or significant other injury ≤ 4 weeks prior to start of study treatment.
. History of other active malignancies within 2 years with exception of (i) adequately treated in situ cancer of the cervix, (ii) non-melanoma skin cancer, or (iii) localized adequately treated cancer with curative intent or malignancy diagnosed \> 2 years ago with no evidence of disease and no treatment ≤ 2 years prior to study treatment.
. Active infection requiring systemic treatment.
. Known human immunodeficiency virus (HIV) or active viral hepatitis.
. Active, clinically significant cardiac disease or any Class 3 or 4 cardiac disease, ventricular arrhythmia or Cerebrovascular Accident (CVA) ≤ 6 months prior to start of treatment.
. Active clinically significant gastrointestinal disease.
6
Phase 1b Arm C: Number of Cycles of Treatment Received by Participants
Timeframe: From the date of first dose up to EOS visit ( up to 3 years and 7.5 months)
7
Phase 1b Arm C: Average Dose Intensity of Pamiparib And TMZ Received Per Participant
Timeframe: From the date of first dose until EOS visit (up to 3 years and 7.5 months)