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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02660034




Registration number
NCT02660034
Ethics application status
Date submitted
11/01/2016
Date registered
21/01/2016
Date last updated
6/12/2018

Titles & IDs
Public title
The Safety, Pharmacokinetics and Antitumor Activity of BGB-A317 in Combination With BGB-290 in Subjects With Advanced Solid Tumors
Scientific title
A Phase 1/1b, Open Label, Multiple Dose, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics and Antitumor Activity of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Combination With the PARP Inhibitor BGB-290 in Subjects With Advanced Solid Tumors
Secondary ID [1] 0 0
BGB-A317/BGB-290_Study_001
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - tislelizumab
Treatment: Drugs - pamiparib

Experimental: Phase 1A - Approximately 50 subjects for the dose escalation until maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) determination

Experimental: Phase 1B - Approximately 180 subjects for expansion in eight selected arms with nine cohorts.


Other interventions: tislelizumab


Treatment: Drugs: pamiparib


Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part A: Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 - Safety and tolerability as assessed by the incidence and nature of AEs.
Timepoint [1] 0 0
from the day of first administration of study drugs up to 30 days after the last administration of pamiparib and up to 90 days after the last administration of tislelizumab.
Primary outcome [2] 0 0
Part A: Incidence and nature of Dose Limiting Toxicities
Timepoint [2] 0 0
from the day of first administration of study drugs up to 30 days after the last administration of pamiparib and up to 90 days after the last administration of tislelizumab.
Primary outcome [3] 0 0
Part A: Determination of maximum tolerated dose of the combination of tislelizumab and pamiparib
Timepoint [3] 0 0
from the day of first administration of study drugs up to 30 days after the last administration of pamiparib and up to 90 days after the last administration of tislelizumab.
Primary outcome [4] 0 0
Part B: Disease response as determined by Overall Response Rate per RECIST Version 1.1 - Anti-tumor activity as determined by the ORR. Radiological assessment of tumor response should be performed approximately every 9 ± 1 weeks in the first 12 months and approximately every 12 ± 1 weeks from screening until unequivocal PD is documented, the patient starts new anti-cancer therapies, patient withdraws consent from the trial, date of death from any cause, or completes a total of 2 years treatment.
Timepoint [4] 0 0
From randomisation until unequivocal PD is documented, the patient starts new anti-cancer therapies, patient withdraws consent from the trial, date of death from any cause, or completes a total of 2 years treatment.
Primary outcome [5] 0 0
Part B: Disease response as determined by Progression Free Survival per RECIST Version 1.1 - Anti-tumor activity as determined by the PFS. Radiological assessment of tumor response should be performed approximately every 9 ± 1 weeks in the first 12 months and approximately every 12 ± 1 weeks from screening until unequivocal PD is documented, the patient starts new anti-cancer therapies, patient withdraws consent from the trial, date of death from any cause, or completes a total of 2 years treatment.
Timepoint [5] 0 0
From randomisation until unequivocal PD is documented, the patient starts new anti-cancer therapies, patient withdraws consent from the trial, date of death from any cause, or completes a total of 2 years treatment.
Primary outcome [6] 0 0
Part B: Disease response as determined by Duration of Response per RECIST Version 1.1 - Anti-tumor activity as determined by the DOR. Radiological assessment of tumor response should be performed approximately every 9 ± 1 weeks in the first 12 months and approximately every 12 ± 1 weeks from screening until unequivocal PD is documented, the patient starts new anti-cancer therapies, patient withdraws consent from the trial, date of death from any cause, or completes a total of 2 years treatment.
Timepoint [6] 0 0
From randomisation until unequivocal PD is documented, the patient starts new anti-cancer therapies, patient withdraws consent from the trial, date of death from any cause, or completes a total of 2 years treatment.
Primary outcome [7] 0 0
Part B: Disease response as determined by Disease Control Rate per RECIST Version 1.1 - Anti-tumor activity as determined by the DCR. Radiological assessment of tumor response should be performed approximately every 9 ± 1 weeks in the first 12 months and approximately every 12 ± 1 weeks from screening until unequivocal PD is documented, the patient starts new anti-cancer therapies, patient withdraws consent from the trial, date of death from any cause, or completes a total of 2 years treatment.
Timepoint [7] 0 0
From randomisation until unequivocal PD is documented, the patient starts new anti-cancer therapies, patient withdraws consent from the trial, date of death from any cause, or completes a total of 2 years treatment.
Primary outcome [8] 0 0
Part B: Disease response as determined by Clinical Benefit Rate per RECIST Version 1.1 - Anti-tumor activity as determined by the CBR. Radiological assessment of tumor response should be performed approximately every 9 ± 1 weeks in the first 12 months and approximately every 12 ± 1 weeks from screening until unequivocal PD is documented, the patient starts new anti-cancer therapies, patient withdraws consent from the trial, date of death from any cause, or completes a total of 2 years treatment.
Timepoint [8] 0 0
From randomisation until unequivocal PD is documented, the patient starts new anti-cancer therapies, patient withdraws consent from the trial, date of death from any cause, or completes a total of 2 years treatment.
Primary outcome [9] 0 0
Part B: Disease response as determined by overall survival - Anti-tumor activity as determined by the OS.
Timepoint [9] 0 0
From randomisation until the patient withdraws consent from the trial, date of death from any cause, or completes a total of 2 years treatment.
Secondary outcome [1] 0 0
Part A: Pharmacokinetic parameters, including but not limited to Ctrough of tislelizumab
Timepoint [1] 0 0
pre-dose in Cycle 1, 2, 3, 4, 5, 9 & 17 and at 4 hours in Cycles 2, 3 & 4 (each cycle is 21 days)
Secondary outcome [2] 0 0
Part A: Pharmacokinetic parameters, including but not limited to Cmax of pamiparib
Timepoint [2] 0 0
pre-dose in Cycle 2 & 3, and at 0.5, 1, 2, 4 & 7 hours post dose in Cycle 2 (each cycle is 21 days)
Secondary outcome [3] 0 0
Part A: Pharmacokinetic parameters, including but not limited to Tmax of pamiparib
Timepoint [3] 0 0
pre-dose in Cycle 2 & 3, and at 0.5, 1, 2, 4 & 7 hours post dose in Cycle 2 (each cycle is 21 days)
Secondary outcome [4] 0 0
Part A: Pharmacokinetic parameters, including but not limited to Ctrough of pamiparib
Timepoint [4] 0 0
pre-dose in Cycle 2 & 3, and at 0.5, 1, 2, 4 & 7 hours post dose in Cycle 2 (each cycle is 21 days)
Secondary outcome [5] 0 0
Part A: Disease response as determined by Overall Response Rate per RECIST Version 1.1 - Anti-tumor activity as determined by the ORR. Radiological assessment of tumor response should be performed approximately every 9 ± 1 weeks in the first 12 months and approximately every 12 ± 1 weeks from screening until unequivocal PD is documented, the patient starts new anti-cancer therapies, patient withdraws consent from the trial, date of death from any cause, or completes a total of 2 years treatment.
Timepoint [5] 0 0
From randomisation until unequivocal PD is documented, the patient starts new anti-cancer therapies, patient withdraws consent from the trial, date of death from any cause, or completes a total of 2 years treatment.
Secondary outcome [6] 0 0
Part A: Disease response as determined by Progression Free Survival per RECIST Version 1.1 - Anti-tumor activity as determined by the PFS. Radiological assessment of tumor response should be performed approximately every 9 ± 1 weeks in the first 12 months and approximately every 12 ± 1 weeks from screening until unequivocal PD is documented, the patient starts new anti-cancer therapies, patient withdraws consent from the trial, date of death from any cause, or completes a total of 2 years treatment.
Timepoint [6] 0 0
From randomisation until unequivocal PD is documented, the patient starts new anti-cancer therapies, patient withdraws consent from the trial, date of death from any cause, or completes a total of 2 years treatment.
Secondary outcome [7] 0 0
Part A: Disease response as determined by Duration of Response per RECIST Version 1.1 - Anti-tumor activity as determined by the DOR. Radiological assessment of tumor response should be performed approximately every 9 ± 1 weeks in the first 12 months and approximately every 12 ± 1 weeks from screening until unequivocal PD is documented, the patient starts new anti-cancer therapies, patient withdraws consent from the trial, date of death from any cause, or completes a total of 2 years treatment.
Timepoint [7] 0 0
From randomisation until unequivocal PD is documented, the patient starts new anti-cancer therapies, patient withdraws consent from the trial, date of death from any cause, or completes a total of 2 years treatment.
Secondary outcome [8] 0 0
Part A: Disease response as determined by Disease Control Rate per RECIST Version 1.1 - Anti-tumor activity as determined by the DCR. Radiological assessment of tumor response should be performed approximately every 9 ± 1 weeks in the first 12 months and approximately every 12 ± 1 weeks from screening until unequivocal PD is documented, the patient starts new anti-cancer therapies, patient withdraws consent from the trial, date of death from any cause, or completes a total of 2 years treatment.
Timepoint [8] 0 0
From randomisation until unequivocal PD is documented, the patient starts new anti-cancer therapies, patient withdraws consent from the trial, date of death from any cause, or completes a total of 2 years treatment.
Secondary outcome [9] 0 0
Part A: Disease response as determined by Clinical Benefit Rate per RECIST Version 1.1 - Anti-tumor activity as determined by the CBR. Radiological assessment of tumor response should be performed approximately every 9 ± 1 weeks in the first 12 months and approximately every 12 ± 1 weeks from screening until unequivocal PD is documented, the patient starts new anti-cancer therapies, patient withdraws consent from the trial, date of death from any cause, or completes a total of 2 years treatment.
Timepoint [9] 0 0
From randomisation until unequivocal PD is documented, the patient starts new anti-cancer therapies, patient withdraws consent from the trial, date of death from any cause, or completes a total of 2 years treatment.
Secondary outcome [10] 0 0
Part A: Disease response as determined by overall survival - Anti-tumor activity as determined by the OS.
Timepoint [10] 0 0
From randomisation until the patient withdraws consent from the trial, date of death from any cause, or completes a total of 2 years treatment.
Secondary outcome [11] 0 0
Part A: Immunogenicity of tislelizumab
Timepoint [11] 0 0
Blood for anti-tislelizumab antibodies should be collected within 24 hours before the start of the first dose of tislelizumab in Cycle 1, and Day 8 of Cycle 1, Day 1 of Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 9 and Cycle 17
Secondary outcome [12] 0 0
Part B: Safety and tolerability as assessed by the incidence and nature of AEs
Timepoint [12] 0 0
from the day of first administration of study drugs up to 30 days after the last administration of pamiparib and up to 90 days after the last administration of tislelizumab.
Secondary outcome [13] 0 0
Part B: Pharmacokinetic parameters, including but not limited to Ctrough of tislelizumab and Pamiparib
Timepoint [13] 0 0
Tislelizumab: Pre-dose in Cycle 1 (day 1 and day 8), and Cycles 2, 3, 4 5, 9 & 17. At 4 hours in Cycles 1 & 5. Pamiparib: Pre-dose and 2 hours post dose in Cycles 1 and 2 (each cycle is 21 days)
Secondary outcome [14] 0 0
Part B: Immunogenicity of tislelizumab
Timepoint [14] 0 0
Cycle 1 (Day 1 & Day 8), and Day 1 of Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 9 and Cycle 17

Eligibility
Key inclusion criteria
1. Patients have voluntarily agreed to participate by giving written informed consent.

2. Patients must have received standard of care in the primary treatment of their
disease.

3. Patients who have the below specified histologically confirmed malignancies that have
progressed to the advanced or metastatic stage.

1. In Part A, the patients must have an advanced malignancy including but not
limited to high-grade serous cancer of the ovary, fallopian tube, or peritoneum,
triple negative breast cancer, SCLC, primary peritoneal cancer, and any tumor
likely to harbor DNA damage repair deficiencies susceptible to treatment with a
PARP inhibitor or likely to be responsive to a PD-1 blocker.

2. In Part B, the patients recruited to one of the eight expansion arms must have
advanced solid tumors of the following types:

Arm 1: Patients with relapsed, platinum-sensitive high grade epithelial, non-mucinous,
ovarian cancer, fallopian tube, or primary peritoneal cancer (EOC) must meet the
following criteria:

i. Patients must have at least 2 prior platinum-containing treatments in any treatment
setting.

• Note: patients may have received additional therapy after the last
platinum-containing regimen if the other eligibility criteria are met.

ii. Patients must have platinum-sensitive recurrent disease and must not have
progressed (by RECIST v1.1 criteria) within 6 months of the completion of the last
platinum containing line of treatment

• Note: patients may receive additional non-platinum based chemotherapy for recurrence
after prior last platinum containing regimen if the criteria for platinum sensitivity
are met.

iii. Arm 1a: Patients with relapsed, platinum-sensitive high grade epithelial,
non-mucinous, ovarian cancer, fallopian tube, or primary peritoneal cancer (EOC) with
either known deleterious or suspected deleterious germline or somatic BRCA1/2
mutations or with HRD

• If HRD or BRCA1/2 mutation status from archival tissue is unknown or has not been
previously evaluated, then the archival tissue must undergo tissue screening using a
validated diagnostic test to determine eligibility. If the diagnostic test result is
BRCA1/2 or HRD positive the patient will be eligible for enrollment in Arm 1a iv. Arm
1b: Patients with relapsed, platinum-sensitive high grade EOC who otherwise meet the
above criteria and are without known germline or somatic BRCA1/2 mutations and without
HRD mutation

Arm 2: Patients with triple negative breast cancer must meet the following criteria:

i. Patients with 0-1 prior platinum-containing treatment in any treatment setting

• Note: patients could have received additional therapy after the last
platinum-containing line of treatment if the other eligibility criteria are met.

ii. Patients who have received at least 1 prior treatment but not more than 3 prior
lines of treatment in the advanced or metastatic setting.

iii. Known deleterious or suspected deleterious germline or somatic BRCA1/2 mutations
or with documented HRD

- If HRD or BRCA1/2 mutation status from archival tissue is unknown or has not been
previously evaluated, then the archival tissue must undergo tissue screening
using a validated diagnostic test to determine eligibility. If the diagnostic
test result is HRD positive, then the patient will be eligible for enrollment in
Arm 2

- If archival tissue is not available and the patient submits a fresh tumor biopsy,
then the diagnostic test needs to demonstrate somatic BRCA1/2 mutation or HRD
positivity.

Arm 3: Patients with metastatic castration-resistant prostate cancer, including but
not limited to mutations in homologous recombination (HR) pathways and/or defined by
HRD algorithms, and must meet the following criteria:

i. The patient may be either chemotherapy-naïve, but must have received prior
abiraterone acetate and/or enzalutamide treatment, or have previously had no more than
2 taxane-based chemotherapy lines of treatment including docetaxel and carbazitaxel.
If docetaxel is used more than once, this will be considered as 1 line of treatment.

ii. At least 2 weeks since the completion of prior flutamide, bicalutamide, and
nilutimide, or enzalutamide and abiraterone treatment.

iii. Documented prostate cancer with one of the following:

- Surgically or medically castrated. The testosterone levels do not need to be
checked if the patient has undergone surgical castration for > 4 months. Patients
receiving chemical castration should have testosterone levels checked at baseline
and confirmed to be in the castrate levels (< 0.5 ng/mL or 1.735 nM). In all
cases the luteinizing hormone-releasing hormone (LHRH) antagonist/agonist is to
be continued in these patients

- Patients with only non-measurable bone lesions must have disease progression
based on PCWG3 with 2 or more new lesions or have prostate-specific antigen (PSA)
progression before enrolment iv. Known deleterious or suspected deleterious
germline or somatic BRCA1/2 mutations or with documented HRD

- If HRD or BRCA1/2 mutation status from archival tissue is unknown or has not been
previously evaluated, then the archival tissue must undergo tissue screening
using a validated diagnostic test to determine eligibility. If the diagnostic
test result is HRD positive, then the patient will be eligible for enrollment in
Arm 3

- If archival tissue is not available and the patient submits a fresh tumor biopsy,
then the diagnostic test needs to demonstrate somatic BRCA1/2 mutation or HRD
positivity.

Arm 4: Patients with extensive-stage disease small cell lung cancer (SCLC) must meet
the following criterion:

i. Patients received at least 1 and not more than 2 prior lines of treatment ii. At
least 1 prior line of treatment must have contained a platinum agent

Arm 5: Patients with HER2-negative gastric or gastroesophageal junction cancer must
meet the following criteria:

i. Patients with HER2-negative may have received at least 1 and not more than 2 prior
lines of treatment

Arm 6: Patients with locally advanced or metastatic urothelial (muscle-invasive
bladder, ureter, urethra or renal pelvis) cancer must meet the following criteria:

i. Patients received at least 1 and not more than 2 prior lines of treatment in the
advanced or metastatic disease setting ii. At least 1 prior line of treatment must
have contained a platinum agent

Arm 7: Patients with advanced or metastatic pancreatic adenocarcinoma must meet the
following criteria:

i. Received at least one but not more than 2 lines of treatment in either an advanced
or metastatic setting; ii. At least 1 prior treatment for advanced or metastatic
disease must have contained a platinum agent iii. Patients with known deleterious
germline or somatic BRCA1/2 mutation can be considered for the study even if
platinum-naive

Arm 8: (NOTE: CLOSED TO ENROLLMENT) Patients with advanced or metastatic recurrent
non-ovarian gynecological cancers (endometrial cancer, cancer of the cervix and
patients with tumors known to be MMR deficient or HRD positive) must meet the
following criteria:

i. Patients with a complete response, partial response or stable disease from at least
1 prior platinum-containing treatment in any treatment setting.

ii. The Sponsor medical monitor will approve tumor types for Arm 8 prior to screening

• Note: Excluded tumor types include patients with bone or soft tissue sarcoma;
central nervous system (CNS) malignancies; colorectal cancer (except microsatellite
instability-high [MSI H] colorectal cancer is permitted); cutaneous or ocular
melanoma; hematologic malignancies; HER2-negative breast cancer without BRCA mutation;
mesothelioma, papillary, follicular, medullary or Hürthle cell thyroid cancer; unknown
primary malignancy

4. Patients who were treated with chemotherapy or any investigational therapies, if
eligible, must have been completed at least 4 weeks or at least 5 half-lives
(whichever is longer, but no less than 3 weeks) before the study drug administration,
and all AEs have either returned to baseline or

5. At least 2 weeks from palliative radiotherapy

6. Patients must have archival tumor tissue or agree to a tumor biopsy for mutation and
biomarkers analysis unless previously discussed with sponsor's medical monitor or its
designee (fresh tumor biopsies are recommended at baseline in patients with readily
accessible tumor lesions and who consent to the biopsies). Patients with ovarian,
fallopian tube, primary peritoneal, or breast cancer in Part A and all patients
enrolled in Part B must also agree to provide fresh blood sample at the baseline for
the evaluation of BRCA mutations and/or confirmation of prior BRCA results or other
homologous recombination deficiency mutations even if it was previously tested

7. Patients must have measurable disease as defined in RECIST v1.1. Patients with
metastatic castration-resistant prostate cancer and epithelial, non-mucinous, ovarian
cancer, fallopian tube, or primary peritoneal cancer may use separate disease-specific
criteria

8. Patients must be a male or female = 18 years of age on the day of signing informed
consent

9. Patients must have an ECOG Performance Status (PS) = 1

10. Patients must have a life expectancy = 12 weeks

11. Patient must have adequate organ function

12. Females of childbearing potential must be willing to use a highly effective method of
birth control for the duration of the study, and for at least 6 months after the last
dose of investigational drug, and have a negative serum pregnancy test within 7 days
of the first dose of study drug(s)

13. Non-sterile males and their female partners must be willing to use a highly effective
method of birth control for the duration of the study and for at least 6 months after
the last dose of investigational drug. Nonsterile males must avoid sperm donation for
the duration of the study and for at least 6 months after last study drug

14. Female patient must agree not to breastfeed starting at screening and throughout the
study period, and for 6 months after the final study drug administration
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

1. Platinum-resistant/refractory disease, defined as progressive disease at the first
tumor assessment while receiving platinum-containing chemotherapy

2. Patient has history of severe hypersensitivity reactions to other monoclonal
antibodies (mAbs).

3. Any major surgery within 28 days before first dose of study drugs.

4. Prior allogeneic stem cell transplantation or organ transplantation.

5. Patients with toxicities (as a result of prior anticancer therapy) which have not
recovered to baseline or stabilized, except for AEs not considered a likely safety
risk (eg, alopecia, neuropathy and specific laboratory abnormalities).

6. Concurrent participation in another therapeutic clinical trial.

7. Prior malignancy within the previous 2 years except for locally curable non-melanoma
dermatologic cancers that have been apparently cured, such as basal or squamous cell
skin cancer, or carcinoma in situ of the skin, cervix, breast, bladder, or prostate.

8. Symptomatic CNS metastasis or leptomeningeal disease. Note: Baseline MRI of the brain
and spinal cord is required for SCLC patients enrolled in Arm 4 if they have a history
of CNS disease.

Note: Patients with previously treated CNS metastatic disease are eligible for any arm
if CNS metastatic disease is asymptomatic, clinically stable, and does not require
corticosteroids or anticonvulsants within a minimum of 4 weeks of enrollment.

9. Prior therapies targeting PD-1, programmed death-ligand 1 (PD-L1), or PARP. The
exception to this criterion are patients eligible for Arm 9; where patients may have
received either a PD-1 inhibitor or PD-L1 inhibitor.

10. Active autoimmune diseases or history of autoimmune diseases that may relapse.

Note: Patients with the following diseases are not excluded and may proceed to further
screening:

1. Controlled Type I diabetes.

2. Hypothyroidism managed with no treatment other than with hormone replacement
therapy.

3. Controlled celiac disease.

4. Skin diseases not requiring systemic treatment (eg, vitiligo, psoriasis,
alopecia).

5. Any other disease that is not expected to recur in the absence of external
triggering factors.

11. Any condition that required systemic treatment with either corticosteroids (> 10 mg
daily of prednisone or equivalent) or other immunosuppressive medication within 2
weeks of the study drug administration.

Note: Patients who are currently or have previously been on any of the following
steroid regimens are not excluded:

1. Adrenal replacement steroid (dose = 10 mg daily of prednisone or equivalent).

2. Topical, ocular, intra-articular, intranasal, or inhalational corticosteroid with
minimal systemic absorption.

3. Short course (= 7 days) of corticosteroid prescribed prophylactically (eg, for
contrast dye allergy) or for the treatment of a non-autoimmune condition (eg,
delayed-type hypersensitivity reaction caused by contact allergen).

12. With severe chronic or active infections requiring systemic antibacterial, antifungal
or antiviral therapy, including tuberculosis infection, etc.

13. History of interstitial lung disease, non-infectious pneumonitis or uncontrolled
systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung
diseases, etc.

14. History of non-viral hepatitis or cirrhosis.

15. Positive human immunodeficiency virus (HIV) status.

16. A known history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.

17. History of alcohol abuse.

18. Underlying medical conditions or alcohol or drug abuse or dependence that, in the
investigator's opinion, will be unfavorable for the administration of study drug or
affect the explanation of drug toxicity or adverse events; or insufficient compliance
during the study according to investigator's judgement.

19. Inability to swallow oral medications (capsules and tablets) without chewing,
breaking, crushing, opening or otherwise altering the product formulation. Patients
should not have gastrointestinal illnesses that would preclude the absorption of
pamiparib, which is an oral agent.

20. Has been administered a live vaccine within 4 weeks (28 days) of initiation of study
therapy.

21. Any of the following cardiovascular criteria:

1. Current evidence of cardiac ischemia.

2. Current symptomatic pulmonary embolism.

3. Acute myocardial infarction = 6 months prior to Day 1.

4. Heart failure of New York Heart Association Classification III or IV = 6 months
prior to Day 1.

5. Grade = 2 ventricular arrhythmia = 6 months prior to Day 1.

6. History of cerebrovascular accident within 6 months before first dose of study
drugs.

22. Use or have anticipated need for food or drugs known to be strong or moderate
cytochrome P450 (CYP)3A inhibitors or strong CYP3A inducers = 10 days (or = 5
half-lives, whichever is shorter) prior to Day 1

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
Single group
Other design features
Phase
Phase 1
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)
ACT,NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
The Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Mid North Coast Cancer Institute - Coffs Harbour
Recruitment hospital [3] 0 0
Calvary Mater Newcastle - Newcastle
Recruitment hospital [4] 0 0
Westmead Hospital - Parramatta
Recruitment hospital [5] 0 0
Prince of Wales - Randwick
Recruitment hospital [6] 0 0
Northern Cancer Institute - St Leonards
Recruitment hospital [7] 0 0
Icon Cancer Care - Brisbane
Recruitment hospital [8] 0 0
Monash Health - Clayton
Recruitment hospital [9] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [10] 0 0
Linear Clinical Research Ltd - Nedlands
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [3] 0 0
2298 - Newcastle
Recruitment postcode(s) [4] 0 0
- Parramatta
Recruitment postcode(s) [5] 0 0
- Randwick
Recruitment postcode(s) [6] 0 0
2065 - St Leonards
Recruitment postcode(s) [7] 0 0
4101 - Brisbane
Recruitment postcode(s) [8] 0 0
- Clayton
Recruitment postcode(s) [9] 0 0
- Melbourne
Recruitment postcode(s) [10] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Tennessee
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Virginia
Country [11] 0 0
France
State/province [11] 0 0
Paris
Country [12] 0 0
France
State/province [12] 0 0
Rennes
Country [13] 0 0
New Zealand
State/province [13] 0 0
Auckland
Country [14] 0 0
New Zealand
State/province [14] 0 0
Wellington
Country [15] 0 0
Spain
State/province [15] 0 0
Barcelona
Country [16] 0 0
Spain
State/province [16] 0 0
Valencia
Country [17] 0 0
United Kingdom
State/province [17] 0 0
London

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 Genetic Laboratories, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The Safety, Pharmacokinetics and Antitumor Activity of the Anti-PD-1 Monoclonal Antibody
BGB-A317 in Combination With the PARP Inhibitor BGB-290 in Subjects With Advanced Solid
Tumors
Trial website
https://clinicaltrials.gov/show/NCT02660034
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Virginia Paton, MD.
Address 0 0
BeiGene
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Rob Stewart
Address 0 0
Country 0 0
Phone 0 0
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/NCT02660034