IVD1: The primary objective of this clinical performance study is to evaluate the effectiveness of the MyChoice® test in identifying HRRm or non-HRRm mCSPC patients as part of the enrolment criteria for EvoPAR-prostate01. This clinical performance…
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
IVD1: The clinical performance is defined as the ability of the device to act
as a companion diagnostic in mCSPC patients for treatment eligibility with
AZD5305 (Saruparib) plus SOC ADT + NHA. The primary endpoint of the main study
is to demonstrate superiority of AZD5305 (Saruparib) + physician*s choice NHA
relative to placebo + physician*s choice NHA by assessment of radiographic
progression-free survival (rPFS) in participants with mCSPC (in BRCAm and in
non-HRRm).
IVD2: The clinical performance is defined as the ability of the device to act
as a companion diagnostic in mCSPC patients for treatment eligibility with
AZD5305 (saruparib) plus SOC ADT + NHA. The primary endpoint of the main study
is to demonstrate superiority of AZD5305 (saruparib) + physician*s choice NHA
relative to placebo + physician*s choice NHA by assessment of radiographic
progression-free survival (rPFS) in participants with mCSPC (in BRCAm and in
non-HRRm).
Secondary outcome
N/A
Background summary
IVD1: This clinical performance study will utilize the Myriad MyChoice test to
prospectively select patients for further stratification and subsequent
randomization into the EvoPAR-prostate01 (D9723C0001) study, which is a
double-blind, Phase III study of AZD5305 (Saruparib) in combination with
physician*s choice new hormonal agents in patients with HRRm and non-HRRm
metastatic Castration-Sensitive Prostate Cancer. As such, use of the device
will be restricted to [pre-screening or screening] and will occur prior to the
receipt of any investigational therapy(ies). This stratification study will
prospectively test tumour FFPE using the MyChoice test to identify patients
with either HRRm or non-HRRm for the treatment with AZD5305 (Saruparib) plus
ADT/NHA, or placebo plus ADT/NHA.
The EvoPAR-prostate01 study will study the efficacy and safety of AZD5305
(Saruparib) plus ADT/NHA compared with placebo plus ADT/NHA in patients with
mCSPC in HRRm and non-HRRm populations separately.
The efficacy analyses conducted by AstraZeneca for EvoPar Prostate 01 to
evaluate the efficacy and safety of their investigational therapy will also
provide the basis for the clinical performance evaluation of the MyChoice to
identify HRRm or non HRRm patients who will benefit from AZD5305 (Saruparib) in
combination with new hormonal agents.
IVD2: This clinical performance study protocol (CPSP) relates to the use of the
FoundationOne®Liquid CDx (F1LCDx) assay as part of the EvoPAR-prostate01 drug
clinical study to identify HRRm or non-HRRm metastatic Castration-Sensitive
Prostate Cancer (mCSPC) patients. Whilst the clinical performance study and
corresponding CPSP will comply with relevant requirements under the IVDR
(Regulation (EU) 2017/746), the clinical study for the investigational
medicinal product (IMP) will comply with relevant requirements under the
clinical trials regulation (CTR; Regulation (EU) No 536/2014; link). This
document relates solely to IVDR requirements, and the diagnostic device used
for patient selection, unless otherwise specified.
The objective of this clinical performance study is to establish the clinical
performance of the F1LCDx assay as a companion diagnostic (CDx) for AZD5305
(saruparib, PARPi) in patients with mCSPC harbouring qualifying alterations in
HRR genes, specifically ATM, BARD1, BRCA1, BRCA2, CDK12, PALB2, RAD51B, RAD51C,
or RAD51D. This clinical performance study will be conducted in accordance with
the EU Regulation 2017/746 on in vitro Diagnostic Medical Devices and ISO
20916:2019 In vitro diagnostic medical devices * Clinical performance studies
using specimens from human subjects * Good study practice, and to provide data
to demonstrate the product is safe and effective for its intended use.
This clinical performance study plan (CPSP) will be executed in combination
with the clinical trial, EvoPAR-Prostate01(D9723C00001). D9723C00001 is a
Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of
AZD5305 (saruparib) in Combination with Physician*s Choice New Hormonal Agents
in Patients with HRRm and non-HRRm mCSPC.
Study objective
IVD1: The primary objective of this clinical performance study is to evaluate
the effectiveness of the MyChoice® test in identifying HRRm or non-HRRm mCSPC
patients as part of the enrolment criteria for EvoPAR-prostate01. This clinical
performance study is intended to obtain clinical evidence for use of this
device as a CDx in mCSPC patients for treatment eligibility with AZD5305
(Saruparib) plus ADT/NHA. This clinical performance study is to support the AZ
EvoPAR-prostate01 clinical trial (D9723C00001) by determining HRR gene mutation
status in FFPE tumour samples from mCSPC subjects as part of enrolling patients
in AZ EvoPAR-prostate01 clinical trial (D9723C00001).
IVD2: This clinical performance study will evaluate the effectiveness of the
F1LCDx test in identifying HRR status in metastatic castration sensitive
prostate cancer patients and generate clinical validation data for the
diagnostic device.
This clinical performance study is to support the AZ EvoPAR-Prostate01 clinical
trial (D9723C00001) by determining HRR gene mutation status in ctDNA from mCSPC
subjects as part of enrolling patients in AZ EvoPAR-Prostate01 clinical trial
(D9723C00001).
Study design
Myriad MyChoice® and F1LCDx assay will be used to assess the HRRm expression
from tumor specimens and blood (ctDNA) collected from patients who are being
screened to determine eligibilty to participate in AstraZeneca study
EvoPAR-Prostate01.
IVD1: Myriad MyChoice® is a qualitative, semi-automated next generation
sequencing-based in vitro diagnostic test to detect and classify single
nucleotide variants, insertions and deletions, and large rearrangements in a
multi-gene panel and to calculate the genomic instability score (GIS) using DNA
isolated from fixed tumor tissue specimens. The test is intended to be used as
a companion diagnostic to select patients with specific cancer types for
treatment with targeted therapy as listed in the table below.
IVD2: F1LCDx utilizes ctDNA isolated from plasma derived from the
anti-coagulated peripheral whole blood of cancer patients. The test is intended
to be used as a CDx to identify patients who may benefit from treatment with
targeted therapies in accordance with the approved therapeutic product
labeling. Additionally, F1LCDx is intended to provide tumour mutation profiling
for patients with malignant neoplasms.
Intervention
Blood sample will be collected during the HRRm biomarker period. If not
present: tumor biopsy is collected as well.
Study burden and risks
A blood sample is taken during the biomarker testing period and a new biopsy
may have to be taken if no or not enough tissue is available.
Prinses Beatrixlaan 582
Den Haag 2595BM
NL
Prinses Beatrixlaan 582
Den Haag 2595BM
NL
Listed location countries
Age
Inclusion criteria
IVD1:
- Provision of a FFPE tumour tissue sample and a blood sample (for ctDNA) as
specified.
- FFPE samples from primary or metastatic sites.
- Archival or newly acquired FFPE tumour tissue samples are permitted provided
they are taken as part of routine clinical practice.
- Specimens must be either a solid tumour prepared as an FFPE block or FFPE
slide sections that are 4-5 microns thick.
IVD2:
- 2 x 10mL Streck Cell-Free DNA BCT collection tubes of whole blood must be
submitted prior to study enrollment for testing with F1LCDx.
- Samples to be provided prior to starting ADT, if possible.
- To ship as soon as possible after collection within the 14 days stability
window at temperature range of 6°C to 37°C.
Exclusion criteria
IVD1:
- Tumour Content (<20%)*.
- Number of slides (<21)*.
- Stained or broken slides.
- Bone metastasis samples with acid decalcification treatment, brain metastasis
and central nervous system metastasis.
- Specimen taken from previously irradiated lesion.
* if a sample does fall below these levels, the site should contact the
AstraZeneca study team for advice before excluding the sample.
IVD2:
- Tissue, other liquid samples besides whole blood are excluded.
- Samples yielding plasma volume <2.5mL.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL85496.000.23 |