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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03150810
Ethics application status
Date submitted
8/05/2017
Date registered
12/05/2017
Date last updated
19/07/2019

Titles & IDs
Public title
Study to Assess Safety, Tolerability and Clinical Activity of BGB-290 in Combination With Temozolomide (TMZ) in Subjects 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 - BGB-290
Treatment: Drugs - Temozolomide
Treatment: Drugs - BGB-290
Treatment: Drugs - Temozolomide

Experimental: Arm A (Dose Escalation) - Approximately 25 subjects to receive continuous BGB-290 and TMZ (Days 1 - 7 of 28 day cycle).

Experimental: Arm B (Dose Escalation) - Approximately 25 subjects to receive continuous BGB-290 and continuous TMZ (28-day cycle).

Experimental: Arm C (Dose Expansion) - Approximately 100 subjects to receive BGB-290 and TMZ.


Treatment: Drugs: BGB-290
BGB-290

Treatment: Drugs: Temozolomide
TMZ

Treatment: Drugs: BGB-290
Dose/schedule selected based on dose escalation phase.

Treatment: Drugs: Temozolomide
Dose/schedule selected based on dose escalation phase.

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 to 28 days post-dosing.
Primary outcome [2] 0 0
Incidence, nature and severity of adverse events as assessed by CTCAE.
Timepoint [2] 0 0
From first dose BGB-290 to 30 days post-dosing.]
Secondary outcome [1] 0 0
Pharmacokinetic (PK) parameters (Cmax) of BGB-290 and TMZ.
Timepoint [1] 0 0
From first dose BGB-290 to 30 days post-dosing.
Secondary outcome [2] 0 0
Pharmacokinetic (PK) parameters (Tmax) of BGB-290 and TMZ.
Timepoint [2] 0 0
From first dose BGB-290 to 30 days post-dosing.
Secondary outcome [3] 0 0
Objective response rate (ORR) as assessed using RECIST.
Timepoint [3] 0 0
From first dose BGB-290 to first documentation of disease progression, assessed up to 5 years.
Secondary outcome [4] 0 0
Duration of response (DOR).
Timepoint [4] 0 0
From first dose BGB-290 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 to first documentation of disease progression while subject 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 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 until date of death, assessed up to 5 years

Eligibility
Key inclusion criteria
All subjects

1. Age =18 years old.

2. Confirmed malignancy at advanced or metastatic stage.

3. ECOG status = 1.

4. Adequate bone marrow function.

5. Adequate renal and hepatic function.

6. 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
90 days after last dosing.

7. Must have measurable or evaluable disease per RECIST [Dose escalation phase only]

Additional inclusion criteria 8 - 12 are specific to tumor types in dose expansion
phase:

8. Ovarian cancer

1. Previously received at least 1 line of platinum containing chemotherapy.

2. No progression or recurrent disease in 6 months from last platinum containing
regimen.

9. Triple-Negative Breast Cancer

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

10. Prostate cancer

1. Documented progressive disease.

2. Chemotherapy-naïve or previously received =2 taxane-based regimens.

3. May be pre-or post-treatment with a novel androgen receptor targeted agent.

4. Completed in = 2 weeks radiation or treatment with anti-androgen agents.

11. Ovarian, breast and prostate cancer: If homologous recombinant deficiency (HRD) or
BRCA status unknown, need pre-screening for eligibility.

12. Small cell lung and gastric cancer: previously received = 2 prior lines of therapy.
Minimum age
18 Years
Maximum age
99 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
All subjects

1. Prior exposure to a PARP inhibitor.

2. Prior chemotherapy, biologic therapy, immunotherapy or investigational agents within 3
weeks prior to start of study treatment.

3. Refractory to platinum-based therapy.

4. Toxicity of = Grade 2 from prior therapy.

5. Major surgery or significant injury = 4 weeks prior to start of study treatment.

6. History of other active malignancies within 2 years with exception of (i) adequately
treated in situ carcinoma 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.

7. Untreated leptomeningeal or brain metastasis.

8. Active infection requiring systemic treatment.

9. Known human immunodeficiency virus (HIV) or active viral hepatitis.

10. Active, clinically significant cardiac disease or any Class 3 or 4 cardiac disease,
ventricular arrhythmia or CVA = 6 months prior to start of treatment.

11. Active, clinically significant gastrointestinal disease.

12. Use of any medications or food known to be strong or moderate cytochrome P450, family
3, subfamily A (CYP3A) inhibitors or strong inducers.

13. Pregnant or nursing females.

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
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Saint Vincent's Hospital - Darlinghurst
Recruitment hospital [3] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Michigan
Country [2] 0 0
United States of America
State/province [2] 0 0
Missouri
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Tennessee
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
Spain
State/province [6] 0 0
Barcelona
Country [7] 0 0
Spain
State/province [7] 0 0
Madrid
Country [8] 0 0
Spain
State/province [8] 0 0
Valencia
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Greater London
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Newcastle Upon Tyne
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Strathclyde
Country [12] 0 0
United Kingdom
State/province [12] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
BeiGene USA, Inc.
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
This study is to evaluate the safety, efficacy and clinical activity of BGB-290 and
temozolomide (TMZ) in subjects with locally advanced or metastatic solid tumors.
Trial website
https://clinicaltrials.gov/show/NCT03150810
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Claudia Andreu-Vieyra
Address 0 0
Country 0 0
Phone 0 0
1 (877) 828-5568
Fax 0 0
Email 0 0
clinicaltrials@beigene.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03150810