A Study Assessing Pamiparib With Radiation and/or Temozolomide (TMZ) in Participants With Newly Dā¦ (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 States116 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 range18 Years
SexALL
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Inclusion criteria
ā. Age ā„ 18 years old.
ā. Confirmed diagnosis of glioblastoma (WHO Grade IV).
ā. Agreement to provide archival tumor tissue for exploratory biomarker analysis
ā. Ability to undergo serial MRIs.
ā. Eastern Cooperative Oncology Group (ECOG) status ā¤ 1.
ā. Adequate hematologic and end-organ function
ā. 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.
ā. Ability to swallow whole capsules.
Exclusion criteria
ā. Prior chemotherapy, biologic therapy, immunotherapy or investigational agents ā¤21 days prior to start of study treatment.
ā. Toxicity of ā„ Grade 2 from prior therapy.
ā. Major surgery or significant other injury ā¤ 4 weeks prior to start of study treatment.
ā. 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 ā¤ 2 years prior to study treatment.
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)
ā. Active infection requiring systemic treatment.
ā. Known human immunodeficiency virus (HIV) or active viral hepatitis.
ā. Active, clinically significant cardiac disease or any Class 3 or 4 cardiac disease, ventricular arrhythmia or Cerebrovascular Accident (CVA) ā¤ 6 months prior to start of treatment.
ā. Active clinically significant gastrointestinal disease.
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)