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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: Dose Escalation: Pamiparib + Temozolomide (TMZ) 40 milligrams (mg) (Days 1-7) - Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 7 within a 28-day cycle

Experimental: Dose Escalation: Pamiparib + TMZ 60 mg (Days 1-7) - Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 60 mg once daily on Days 1 to 7 within a 28-day cycle

Experimental: Dose Escalation: Pamiparib + TMZ 80 mg (Days 1-7) - Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 80 mg once daily on Days 1 to 7 within a 28-day cycle

Experimental: Dose Escalation: Pamiparib + TMZ 100 mg (Days 1-7) - Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 100 mg once daily on Days 1 to 7 within a 28-day cycle

Experimental: Dose Escalation: Pamiparib + TMZ 120 mg (Days 1-7) - Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 120 mg once daily on Days 1 to 7 within a 28-day cycle

Experimental: Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-14) - Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 14 within a 28-day cycle

Experimental: Dose Escalation: Pamiparib + TMZ 20 mg (Days 1-28) - Pamiparib 60 mg twice daily in combination with TMZ 20 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle

Experimental: Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-28) - Pamiparib 60 mg twice daily in combination with TMZ 40 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle

Experimental: Dose Expansion: Gastric Cancer - Participants with gastric or gastroesophageal junction cancer received TMZ 60 mg administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle

Experimental: Dose Expansion: Ovarian Cancer - Participants with ovarian cancer, fallopian cancer, or primary peritoneal cancer received TMZ 60 mg administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle

Experimental: Dose Expansion: SCLC - Participants with Small Cell Lung Cancer (SCLC) received TMZ 60 mg administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle

Experimental: Dose Expansion: TNBC - Participants with triple negative breast cancer (TNBC) received TMZ 60 mg administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle

Experimental: Dose Expansion: Other HRD+ Cancers - Participants with non-small cell lung cancer (NSCLC), esophageal cancer, squamous head and neck cancer, or soft tissue sarcomas whose tumors are homologous recombination deficiency (HRD)+ received TMZ 60 mg administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle


Treatment: Drugs: Pamiparib
Administered by mouth as a capsule twice daily

Treatment: Drugs: Temozolomide
TMZ at various doses administered by mouth as a capsule once daily.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs)
Timepoint [1] 0 0
From first dose of study drug(s) to 28 days post-dose (up to approximately 1 year and 6 months)
Primary outcome [2] 0 0
Number of Participants Experiencing Adverse Events (AEs)
Timepoint [2] 0 0
From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
Primary outcome [3] 0 0
Objective Response Rate (ORR)
Timepoint [3] 0 0
Up to approximately 5 years and 10 months
Secondary outcome [1] 0 0
Maximum Observed Plasma Concentration (Cmax) of Pamiparib
Timepoint [1] 0 0
2 days before Cycle 1 Day 1 (Day -2) at predose, 30 min, 1, 2, 4, 6, 24, and 48 hours after dosing, and on Cycle 1 Day 15 at predose, 1, 2, and 4 hours postdose (each cycle is 28 days)
Secondary outcome [2] 0 0
Plasma Trough Concentrations of Pamiparib (Ctrough)
Timepoint [2] 0 0
Cycle 1 Day 15 predose
Secondary outcome [3] 0 0
Time to Reach Cmax (Tmax) of Pamiparib
Timepoint [3] 0 0
2 days before Cycle 1 Day 1 (Day -2) at predose, 30 min, 1, 2, 4, 6, 24, and 48 hours after dosing, and on Cycle 1 Day 15 at predose, 1, 2, and 4 hours postdose.
Secondary outcome [4] 0 0
Area Under the Curve From Time 0 to 4 Hours (AUC0-4h) of Pamiparib
Timepoint [4] 0 0
2 days before Cycle 1 Day 1 (Day -2) at predose, 30 min, 1, 2, and 4 hours after dosing, and on Cycle 1 Day 15 at predose, 1, 2, and 4 hours postdose.
Secondary outcome [5] 0 0
Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Pamiparib
Timepoint [5] 0 0
2 days before Cycle 1 Day 1 (Day -2) at predose, 30 min, 1, 2, 4, 6, 24, and 48 hours after dosing
Secondary outcome [6] 0 0
Terminal Elimination Half-life (t1/2) of Pamiparib
Timepoint [6] 0 0
2 days before Cycle 1 Day 1 (Day -2) at predose, 30 min, 1, 2, 4, 6, 24, and 48 hours after dosing (each cycle is 28 days)
Secondary outcome [7] 0 0
Apparent Clearance (CL/F) of Pamiparib
Timepoint [7] 0 0
2 days before Cycle 1 Day 1 (Day -2) at predose, 30 min, 1, 2, 4, 6, 24, and 48 hours after dosing (each cycle is 28 days)
Secondary outcome [8] 0 0
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Pamiparib
Timepoint [8] 0 0
2 days before Cycle 1 Day 1 (Day -2) at predose, 30 min, 1, 2, 4, 6, 24, and 48 hours after dosing (each cycle is 28 days)
Secondary outcome [9] 0 0
Plasma Concentration of Temozolomide (TMZ)
Timepoint [9] 0 0
Predose (within 30 min prior to dose) and 1 hour post dose on Cycle 1 Day 1 and Cycle 1 Day 7
Secondary outcome [10] 0 0
Disease Control Rate (DCR)
Timepoint [10] 0 0
Up to approximately 5 years and 10 months
Secondary outcome [11] 0 0
Duration of Response (DOR)
Timepoint [11] 0 0
Up to approximately 5 years and 10 months
Secondary outcome [12] 0 0
Progression Free Survival (PFS)
Timepoint [12] 0 0
Up to approximately 5 years and 10 months)
Secondary outcome [13] 0 0
Overall Survival (OS)
Timepoint [13] 0 0
Up to approximately 5 years and 10 months

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
3. Have disease either evaluable (dose-escalation cohort) or measurable (dose-escalation and -expansion cohorts) per RECIST V1.1, except for prostate cancer participants
4. Agree to provide archival tumor tissue
5. Additional inclusion criteria for dose expansion cohorts:

* Participants with homologous recombination deficiency (HRD+) or known BRCA mutant ovarian cancer Previously received at least one line of platinum-containing therapy in the advanced or metastatic setting and No progression or recurrent disease within 6 months from last platinum-containing regimen.
* Participants with HRD+ or known BRCA mutant triple-negative breast cancer Up to one prior platinum-containing treatment in any treatment setting and up to 3 prior lines of therapy in the advanced or metastatic setting
* Participants with HRD+ or known BRCA mutant prostate cancer Chemotherapy-naïve or previously received up to two taxane-based chemotherapy regimens, with documented prostate cancer progression
* Participants with small cell lung cancer and gastric cancer, previously received = 2 prior lines of therapy
* Other HRD+ solid tumors of multiple indications

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

1. Prior treatment with a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor.
2. Refractory to platinum-based therapy (dose-expansion cohort).

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
Chris Obrien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Saint Vincents Hospital Sydney - Darlinghurst
Recruitment hospital [3] 0 0
Icon Cancer Centre South Brisbane - South Brisbane
Recruitment hospital [4] 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
4101 - South Brisbane
Recruitment postcode(s) [4] 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
Sevilla
Country [9] 0 0
Spain
State/province [9] 0 0
Valencia
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Glasgow
Country [11] 0 0
United Kingdom
State/province [11] 0 0
High Heaton
Country [12] 0 0
United Kingdom
State/province [12] 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 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
Study Director
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?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03150810