pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC) KRAS change KRASG12D mutation
Conditions
Interventions
Blood sample will be collected during the pre-screening period. If not present:
tumor biopsy is collected as well.
Sponsors
Astra Zeneca
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Sample Inclusion Criteria: For the IVD study, this will include tumour tissue sent as part of the main clinical trial that meets the central laboratory tissue sample quality requirements. All of the following requirements must be met for the sample to pass the Foundation Medicine pathology review for processing with the F1CDx: • Primary Specimen ID and Subject ID accompanying sample • FFPE specimens, including tumour resections and core needle biopsies. • Archival FFPE tumour samples from the most recently collected tumour tissue sample, derived from the primary or recurrent cancer site. • Optimal tissue volume of at least 0.6 mm3 or absolute minimum tissue volume of 0.2 mm3 • Final percent tumour nuclei of at least 20% (optimally 30% or greater) • Sufficient cellularity - determined by Foundation Medicine, Inc. pathologist discretion. • 10 x 4 micron sections on positively charged slides, minimum of 3 consecutive slides
Exclusion criteria
Exclusion criteria: Sample Exclusion Criteria: • Fine-needle aspirates (FNA) and effusion cytology samples/other sample types agreed with study team are NOT accepted. • Sample is fixed in anything other than 10% NBF (e.g. Bouins, B5, Holland*s, zinc buffered formalin). • Samples baked above 37 degrees Celsius. • Blocks larger than 30 x 25 mm cannot be processed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the clinical trial D0780C00001 (ALAFOSS-01) is to investigate the safety and tolerability, determine the MTD and/or OBD of AZD0022 as monotherapy and in combination with anti-cancer agents in participants with advanced tumours harbouring a KRASG12D mutation, as well as to estimate the anti-tumour activity of AZD0022 as a monotherapy and in combination with other anti-cancer agents. The same efficacy endpoint(s) will be used to establish the clinical performance of F1CDx as a CDx for AZD0022 in patients with NSCLC, CRC, or PDAC with a KRASG12D mutation who are most likely to benefit from AZD0022 as monotherapy or in combination with other anti-cancer agents. Data from this study may be used to support CDx approval from health authorities to demonstrate the device is safe and effective for its intended use. The primary endpoint of the assessment of safety and tolerability, and the MTD and/or OBD is to determine the incidence and severity of AEs/SAEs, incidence of DLTs (Dose escalation), clinically significant changes in vital signs, laboratory parameters, and ECG results, and discontinuation of AZD0022 due to toxicity. Efficacy endpoints of anti-tumour activity of AZD0022 as a monotherapy and in combination with other anti-cancer agents are defined as Radiological response evaluated according to RECIST v1.1 (ORR, CR rate, DoR, DCR, DRR, TTR, PFS, and change in tumour size) and OS. | — |
Countries
Netherlands
Outcome results
None listed