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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03150810




Registration number
NCT03150810
Ethics application status
Date submitted
8/05/2017
Date registered
12/05/2017

Titles & IDs
Public title
Study to Assess Safety, Tolerability and Clinical Activity of BGB-290 in Combination With Temozolomide (TMZ) in Participants With Locally Advanced or Metastatic Solid Tumors
Scientific title
A Phase 1b Study to Assess the Safety, Tolerability and Clinical Activity of BGB-290 in Combination With Temozolomide (TMZ) in Subjects With Locally Advanced or Metastatic Solid Tumors
Secondary ID [1] 0 0
2017-001553-14
Secondary ID [2] 0 0
BGB-290-103
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Locally Advanced or Metastatic Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pamiparib
Treatment: Drugs - Temozolomide

Experimental: Arm A (Dose Escalation) TMZ Pulse Dosing - Participants receive continuous BGB-290 and escalating flat doses of 40mg, 80mg, 100mg, 120mg (as 20 mg capsules) daily administered orally up to the maximum tolerated dose (MTD) of TMZ on Days 1 - 7 of a 28-day cycle.

Experimental: Arm B (Dose Escalation) TMZ Continuous Dosing - Participants receive continuous BGB-290 and escalating flat doses of 40mg, 80mg, 100mg, 120mg (as 20 mg capsules) daily administered orally up to the maximum tolerated dose (MTD) of TMZ on Days 1 - 28 of a 28-day cycle.

Experimental: Dose Expansion, 6 cohorts - Participants receive continuous BGB-290 and TMZ at the recommended phase 2 dose (RP2D) and schedule in 28 day cycles


Treatment: Drugs: Pamiparib
60 mg (20 mg capsules) administered orally twice a day

Treatment: Drugs: Temozolomide
Doses of up to 120 mg (as 20 mg capsules) administered orally once daily (QD) as specified in the treatment arm
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and nature of dose limiting toxicities (DLTs) as assessed by CTCAE.
Timepoint [1] 0 0
From first dose BGB-290 and TMZ to 28 days post-dosing
Primary outcome [2] 0 0
Number of participants experiencing Adverse Events (AEs)
Timepoint [2] 0 0
From first dose BGB-290 and TMZ to 30 days post-dosing
Primary outcome [3] 0 0
Number of participants experiencing Severe Adverse Events (SAEs)
Timepoint [3] 0 0
From first dose BGB-290 and TMZ to 30 days post-dosing
Primary outcome [4] 0 0
Objective Response Rate (ORR)
Timepoint [4] 0 0
From first dose BGB-290 and TMZ to first documentation of disease progression, assessed up to 5 years
Secondary outcome [1] 0 0
maximum observed plasma concentration (Cmax) of BGB-290 and TMZ.
Timepoint [1] 0 0
From first dose BGB-290 and TMZ to 30 days post-dosing
Secondary outcome [2] 0 0
lowest concentration reached before the next dose administered (Ctrough) of BGB-290 and TMZ.
Timepoint [2] 0 0
From first dose BGB-290 and TMZ to 30 days post-dosing
Secondary outcome [3] 0 0
time to reach maximum (peak) plasma concentration (Tmax) of BGB-290 and TMZ.
Timepoint [3] 0 0
From first dose BGB-290 and TMZ to 30 days post-dosing
Secondary outcome [4] 0 0
Duration of response (DOR).
Timepoint [4] 0 0
From first dose BGB-290 and TMZ to first documentation of disease progression, assessed up to 5 years
Secondary outcome [5] 0 0
Disease control rate (DCR)
Timepoint [5] 0 0
From first dose BGB-290 and TMZ to first documentation of disease progression while participant is alive, assessed to up 5 years
Secondary outcome [6] 0 0
Progression free survival (PFS)
Timepoint [6] 0 0
From first dose BGB-290 and TMZ to first documentation of disease progression or death, whichever is first, assessed up to 5 years
Secondary outcome [7] 0 0
Overall survival (OS)
Timepoint [7] 0 0
From first dose BGB-290 and TMZ until date of death, assessed up to 5 years

Eligibility
Key inclusion criteria
Key

1. Age =18 years old with advanced or metastatic stage solid tumors
2. Eastern Cooperative Oncology Group (ECOG) status = 1 and measurable disease per RECIST V1.1 (except for participants in dose escalation and prostate cancer participants)
3. Additional inclusion criteria for dose expansion cohorts:

Participants with homologous recombination deficiency (HRD+) or known BRCA mutant Ovarian cancer

a. Previously received at least 1 line of platinum containing chemotherapy and No progression or recurrent disease in 6 months from last platinum containing regimen. Participants with HRD+ or known breast cancer susceptibility gene (BRCA) mutant Triple-Negative Breast Cancer

a. 0 - 1 prior platinum-containing regimen (any treatment setting) and received = 3 prior regimens (advanced or metastatic setting).

Participants with HRD+ or known BRCA mutant Prostate cancer

1. Chemotherapy-naïve or previously received =2 taxane-based regimens.
2. May have pre-or post-treatment with a novel androgen receptor targeted agent. Participants Small cell lung and gastric cancer

a. Previously received = 2 prior lines of therapy. Participants with HRD+ NSCLC, head and neck cancer, esophageal cancer and soft tissue sarcomas

1. Must have tumors with with HRD+ as centrally determined
2. Must have received at least 1 but not more than 3 prior lines of therapy.

Treatment naïve patients with soft tissue sarcoma might be allowed if standard of care therapy is not suitable or available.

Key
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
All participants

1. Prior exposure to a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor.
2. Refractory to platinum-based therapy.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/06/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/05/2023
Sample size
Target
Accrual to date
Final
139
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Saint Vincent's Hospital - Darlinghurst
Recruitment hospital [2] 0 0
Icon Cancer Centre Wesley - Auchenflower
Recruitment hospital [3] 0 0
Icon Cancer Centre Chermside - Chermside
Recruitment hospital [4] 0 0
Icon Cancer Centre North Lakes - North Lakes
Recruitment hospital [5] 0 0
Icon Cancer Centre South Brisbane - South Brisbane
Recruitment hospital [6] 0 0
Icon Cancer Centre Southport - Southport
Recruitment hospital [7] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
4066 - Auchenflower
Recruitment postcode(s) [3] 0 0
4032 - Chermside
Recruitment postcode(s) [4] 0 0
4509 - North Lakes
Recruitment postcode(s) [5] 0 0
4101 - South Brisbane
Recruitment postcode(s) [6] 0 0
4215 - Southport
Recruitment postcode(s) [7] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
United States of America
State/province [2] 0 0
Tennessee
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
Spain
State/province [4] 0 0
Barcelona
Country [5] 0 0
Spain
State/province [5] 0 0
Madrid
Country [6] 0 0
Spain
State/province [6] 0 0
Sevilla
Country [7] 0 0
Spain
State/province [7] 0 0
Valencia
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Greater London
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Newcastle Upon Tyne
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Strathclyde

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
BeiGene
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Myriad Genetics, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Neal Gupta
Address 0 0
BeiGene
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03150810