Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03150862
Registration number
NCT03150862
Ethics application status
Date submitted
8/05/2017
Date registered
12/05/2017
Date last updated
31/05/2022
Titles & IDs
Public title
A Study Assessing Pamiparib With Radiation and/or Temozolomide (TMZ) in Participants With Newly Diagnosed or Recurrent Glioblastoma
Query!
Scientific title
A Phase 1b/2 Study to Assess the Safety, Tolerability and Efficacy of BGB-290 in Combination With Radiation Therapy (RT) and/or Temozolomide (TMZ) in Subjects With First-line or Recurrent/Refractory Glioblastoma
Query!
Secondary ID [1]
0
0
2017-001554-33
Query!
Secondary ID [2]
0
0
BGB-290-104
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Brain and Central Nervous System Tumors
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Brain
Query!
Cancer
0
0
0
0
Query!
Neuroendocrine tumour (NET)
Query!
Cancer
0
0
0
0
Query!
Children's - Brain
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Pamiparib
Treatment: Drugs - TMZ
Treatment: Other - Radiation
Experimental: Arm A (Dose Escalation) - Participants with newly diagnosed unmethylated GBM will receive Pamiparib and radiation therapy.
Experimental: Arm B (Dose Escalation) - Participants with newly diagnosed unmethylated GBM will receive Pamiparib, radiation therapy (RT) and temozolomide (TMZ).
Experimental: Arm A (Dose Expansion) - Participants with newly diagnosed unmethylated GBM will receive Pamiparib and radiation therapy.
Experimental: Arm C (Dose Escalation) - Participants with recurrent/refractory methylated or unmethylated GBM will receive Pamiparib and TMZ.
Experimental: Arm C (Dose Expansion-Cohorts C1 and C2) - Participants with recurrent/refractory methylated or unmethylated GBM will receive Pamiparib and TMZ.
Treatment: Drugs: Pamiparib
Administered as specified in the treatment arm
Treatment: Drugs: TMZ
Administered as specified in the treatment arm
Treatment: Other: Radiation
Up to 60 Gy (total) over 6 - 7 weeks
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Intervention code [2]
0
0
Treatment: Other
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Phase 1b Escalation Phase: Number of Participants With Dose-Limiting Toxicities (DLTs) as Assessed by CTCAE
Query!
Assessment method [1]
0
0
A DLT is defined as one of the following toxicities occurring during the DLT assessment window:
Grade =3 non-hematologic, non-hepatic major organ adverse event (AE) Grade 4 neutropenia lasting >7 days Grade =3 febrile neutropenia Grade 3 thrombocytopenia with clinically significant bleeding Grade 4 thrombocytopenia lasting > 3 days and requiring transfusion, or any decreased platelet count <15,000/mm3/ <15.0 x 109/L Grade =4 anemia Grade =3 total bilirubin or hepatic transaminases (ALT or AST)
Query!
Timepoint [1]
0
0
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
Query!
Primary outcome [2]
0
0
Phase 1b Escalation Phase: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as Assessed by CTCAE
Query!
Assessment method [2]
0
0
A treatment-emergent adverse event (TEAE) is defined as an AE that had an onset date on or after first dose of study treatment or was worsening in severity from baseline (pretreatment) up to 30 days following permanent study treatment discontinuation or initiation of new anti-cancer therapy, whichever occurs first.
An SAE is any untoward medical occurrence that, at any dose meets at least one of the following criteria: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is considered a significant medical AE based on medical judgment.
Query!
Timepoint [2]
0
0
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)
Query!
Primary outcome [3]
0
0
Phase 1b Escalation Phase Arm C: Number of Participants With Clinically Relevant Changes in Vital Signs and Clinical Laboratory Measurements
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
From the date of first dose up to end of study (EOS) visit (up to 3 years and 7.5 months)
Query!
Primary outcome [4]
0
0
Phase 2 Arm A: Modified Disease Control Rate (DCR) as Assessed by Response Assessment in Neuro-Oncology (RANO) Criteria
Query!
Assessment method [4]
0
0
Modified DCR is defined as the percentage of participants with complete response (CR), partial response (PR) or stable disease (SD) per RANO criteria as the response assessment at the end-of-treatment (EOT) visit.
Query!
Timepoint [4]
0
0
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)
Query!
Primary outcome [5]
0
0
Phase 2 Arm C: Objective Response Rate (ORR) as Assessed Using RANO Criteria
Query!
Assessment method [5]
0
0
ORR (objective response rate) is defined as percentage of participants with best overall response of CR or PR per RANO criteria (confirmed by a subsequent tumor assessment at least four weeks apart).
Query!
Timepoint [5]
0
0
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)
Query!
Primary outcome [6]
0
0
Phase 1b Arm C: Number of Cycles of Treatment Received by Participants
Query!
Assessment method [6]
0
0
Data shows the number of participants who received treatment for the given number of cycles.
Query!
Timepoint [6]
0
0
From the date of first dose up to EOS visit ( up to 3 years and 7.5 months)
Query!
Primary outcome [7]
0
0
Phase 1b Arm C: Average Dose Intensity of Pamiparib And TMZ Received Per Participant
Query!
Assessment method [7]
0
0
The average dose intensity per participant = total dose (mg) per participant / duration of treatment (days).
Query!
Timepoint [7]
0
0
From the date of first dose until EOS visit (up to 3 years and 7.5 months)
Query!
Secondary outcome [1]
0
0
Phase 1B and Phase 2: Pharmacokinetics: Ctrough of Pamiparib
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Pre-dose, 2 hours post dose on Days 1 and 15 of radiation Therapy
Query!
Secondary outcome [2]
0
0
Phase 1b Arm A and Arm B Escalation Phase: Modified Disease Control Rate as Assessed by RANO Criteria
Query!
Assessment method [2]
0
0
Modified DCR is defined as the percentage of participants with complete response (CR), partial response (PR) or stable disease (SD) per RANO criteria as the response assessment at the end-of-treatment (EOT) visit.
Query!
Timepoint [2]
0
0
From the date of first dose up to first documentation of disease progression while participant is alive (approximately 3 years and 7.5 months)
Query!
Secondary outcome [3]
0
0
Phase 1b Escalation Phase Arm C: Disease Control Rate as Assessed by RANO Criteria
Query!
Assessment method [3]
0
0
DCR is defined as the percentage of participants with best overall response of CR, PR or SD per RANO criteria. CR or PR will be confirmed by a subsequent tumor assessment at least four weeks apart
Query!
Timepoint [3]
0
0
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)
Query!
Secondary outcome [4]
0
0
Phase 1b and Phase 2 Arms A and B: ORR as Assessed Using RANO Criteria
Query!
Assessment method [4]
0
0
ORR is defined as percentage of participants with best overall response of CR or PR per RANO criteria (confirmed by a subsequent tumor assessment at least four weeks apart).
Query!
Timepoint [4]
0
0
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)
Query!
Secondary outcome [5]
0
0
Phase 1b and Phase 2 Arms A, B and C: Clinical Benefit Rate as Assessed Using RANO Criteria
Query!
Assessment method [5]
0
0
Clinical benefit rate (CBR) is defined as the percentage of participants with best overall response of CR, PR or SD = 24 weeks per RANO criteria (confirmed by a subsequent tumor assessment at least four weeks apart).
Query!
Timepoint [5]
0
0
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)
Query!
Secondary outcome [6]
0
0
Phase 1b and Phase 2 Arms A, B and C: Duration of Response (DOR) as Assessed Using RANO Criteria
Query!
Assessment method [6]
0
0
DOR is defined as the time from the date of the earliest documented response to disease progression or death for any cause whichever occurs earlier (confirmed by a subsequent tumor assessment at least four weeks apart).
Query!
Timepoint [6]
0
0
From first documentation of CR or PR to first documentation of disease progression or death (up to 3 years and 7.5 months)
Query!
Secondary outcome [7]
0
0
Phase 1b and Phase 2 Arms A, B and C: Progression Free Survival (PFS) as Assessed Using RANO Criteria
Query!
Assessment method [7]
0
0
PFS is defined as the time from the first dose date to disease progression per RANO criteria or death, whichever occurs first.
Query!
Timepoint [7]
0
0
From the date of first dose up to first documentation of disease progression or death (up to 3 years and 7.5 months)
Query!
Secondary outcome [8]
0
0
Phase 1b and Phase 2 Arms A, B and C: Overall Survival (OS)
Query!
Assessment method [8]
0
0
OS is defined as the time from the first dose date to date of death for any cause.
Query!
Timepoint [8]
0
0
From the date of first dose up to the date of death (up to 3 years and 7.5 months)
Query!
Secondary outcome [9]
0
0
Phase 2 Arms A and C Expansion Phase: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Query!
Assessment method [9]
0
0
A treatment-emergent adverse event (TEAE) is defined as an AE that had an onset date on or after first dose of study treatment or was worsening in severity from baseline (pretreatment) up to 30 days following permanent study treatment discontinuation or initiation of new anti-cancer therapy, whichever occurs first. An SAE is any untoward medical occurrence that, at any dose meets at least one of the following criteria: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is considered a significant medical AE based on medical judgment.
Query!
Timepoint [9]
0
0
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)
Query!
Secondary outcome [10]
0
0
Phase 2 Expansion Phase Arm A and C: Number of Participants With Clinically Relevant Changes in Vital Signs and Clinical Laboratory Measurements
Query!
Assessment method [10]
0
0
Query!
Timepoint [10]
0
0
From the date of first dose up to EOS visit (up to 3 years and 7.5 months)
Query!
Secondary outcome [11]
0
0
Phase 2 Arms A and C Expansion Phase: Number of Cycles of Treatment Received by Participants
Query!
Assessment method [11]
0
0
Data shows the number of participants who received treatment for the given number of cycles.
Query!
Timepoint [11]
0
0
From date of first dose up to EOS Visit (up to 3 years and 7.5 months)
Query!
Secondary outcome [12]
0
0
Phase 2 Arms A and C Expansion Phase: Average Dose Intensity of Pamiparib and TMZ Received Per Participant
Query!
Assessment method [12]
0
0
The average dose intensity per participant = total dose (mg) per participant / duration of treatment (days).
Query!
Timepoint [12]
0
0
From date of first dose up to EOS Visit (up to 3 years and 7.5 months)
Query!
Eligibility
Key inclusion criteria
Key All participants
1. Age = 18 years old.
2. Confirmed diagnosis of glioblastoma (WHO Grade IV).
3. Agreement to provide archival tumor tissue for exploratory biomarker analysis
4. Ability to undergo serial MRIs.
5. Eastern Cooperative Oncology Group (ECOG) status = 1.
6. Adequate hematologic and end-organ function
7. 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.
8. Ability to swallow whole capsules.
Participants in Arms A and B (not Arm C) must meet inclusion criteria # 9 - 11:
9. No previous treatment for GBM except surgery.
10. Able to start radiation therapy = 49 days after surgery but = 14 days after a biopsy
or =28 days after an open biopsy or craniotomy with adequate wound healing.
11. Documented unmethylated MGMT promoter status.
Participants in Arm C Escalation (Phase 1b) must meet inclusion criteria # 12 - 15:
12. Documentation of MGMT promoter status
13. No prior systemic chemotherapy other than TMZ for GBM.
14. Histologically confirmed secondary glioblastoma
15. Disease that is evaluable or measurable as defined by Response Assessment in
Neuro-Oncology (RANO) criteria
Participants in Arm C Expansion (Phase 2), must meet criteria # 16 - 18:
16. Histologically confirmed de novo (primary) glioblastoma with unequivocal first
progressive disease (PD) after RT with concurrent/adjuvant TMZ chemotherapy
17. Disease that is measurable as defined by RANO criteria
18. Documentation of MGMT promoter status
Key
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
All participants
1. Prior chemotherapy, biologic therapy, immunotherapy or investigational agents =21 days
prior to start of study treatment.
2. Toxicity of = Grade 2 from prior therapy.
3. Major surgery or significant other injury = 4 weeks prior to start of study treatment.
4. 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.
5. Active infection requiring systemic treatment.
6. Known human immunodeficiency virus (HIV) or active viral hepatitis.
7. 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.
8. Active clinically significant gastrointestinal disease.
9. Active bleeding disorder = 6 months prior to start of treatment.
10. Need for therapeutic anti-coagulation with heparin, warfarin or other anticoagulants.
11. Use of any medications or food known to be strong or moderate cytochrome P450, family
3, subfamily A (CYP3A) inhibitors or strong inducers.
12. Pregnant or nursing females.
13. Significant intercurrent illness that may result in participant's death prior to death
from glioblastoma.
Arms B and C Only:
14. Known hypersensitivity to any component of TMZ or decarbazine (DTIC).
15. Have hereditary problems of galactose intolerance
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 1/Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
24/07/2017
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
17/03/2021
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
116
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Colorado
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Massachusetts
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Michigan
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Missouri
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
New York
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Ohio
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Oklahoma
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Pennsylvania
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Tennessee
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Utah
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Virginia
Query!
Country [14]
0
0
Netherlands
Query!
State/province [14]
0
0
Rotterdam
Query!
Country [15]
0
0
Switzerland
Query!
State/province [15]
0
0
Zurich
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
BeiGene USA, Inc.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief 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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT03150862
Query!
Trial related presentations / publications
Query!
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
Query!
Contacts
Principal investigator
Name
0
0
Study Director
Query!
Address
0
0
BeiGene
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03150862
Download to PDF